The outbreak that sickened the two Connecticut residents and 16 others nationally, including 1 person in California who died, was probably caused by eating “leafy greens,” but a specific leafy green couldn’t be identified, the Centers for Disease Control and Prevention (CDC) reported. The Canadian government’s Public Health Agency announced on Dec. 11 that the outbreak was linked to romaine lettuce.

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After outbreak of E. coli contamination in December, Rep. Rosa DeLauro was critical of the CDC’s “stunning lack of guidance.”

Maura Downes, the communications director for the Connecticut Department of Public Health, confirmed that two state residents were sickened by the E. coli outbreak.

“One of the two Connecticut patients did develop HUS (hemolytic-uremic syndrome), which required hospitalization,” she said. “That patient has since recovered and has been discharged from the hospital.”

Rep. Rosa DeLauro, D-Conn., said the CDC’s “stunning lack of guidance” during the outbreak is “unconscionable,” because the agency didn’t provide the public with information about the outbreak until late December and seems “content” with ending its investigation without finding the cause of the contamination. The CDC says it alerted the public after lab tests showed the E. coli bacteria strain that affected people in the U.S. was closely related to the one in Canada.

An analysis of CDC’s most recent data by C-HIT reveals that more consumers in Connecticut have been sickened by eating contaminated foods this decade than in any other New England state.

From Jan. 1, 2010, through Dec. 31, 2016, there were 156 food-borne disease outbreaks in Connecticut reported to the CDC, causing 5,258 people to become ill, 852 people to require hospital care and 17 deaths. A food-borne disease outbreak is defined as the occurrence of two or more similar illnesses resulting from the ingestion of a common food.

During the same years in Massachusetts, which has nearly double Connecticut’s population, there were 154 outbreaks, causing 5,072 illnesses, 660 hospitalizations and 16 deaths.

Recent concerns about the inability of the CDC and the Food and Drug Administration to safeguard Americans from recalled tainted foods follow a critical report released in December by the U.S. Department of Health and Human Services’ Office of Inspector General. The report reviewed 30 of the 1,557 food recalls reported to the FDA between Oct. 1, 2012, and May 4, 2015, and found the agency didn’t “always have an efficient and effective food-recall process that ensured the safety of the nation’s food supply.”

The FDA could not always ensure that companies initiated recalls promptly, and the agency didn’t always evaluate health hazards in a timely manner, the report said. It also pointed out deficiencies in the FDA’s recall data and said the agency “obtained incomplete or inaccurate” information from companies initiating recalls.

FDA Commissioner Scott Gottlieb released a statement Dec. 26 admitting “the recall process does not work as well as we’d like,” and “much work remains to be done if we’re going to provide the highest assurance of safety.”

On Jan. 18, Gottlieb issued another statement saying the agency developed draft guidance to make sure that companies promptly communicate recalls to the public and provide “more timely and more accurate information.”

The FDA will, “in some situations,” he says, begin identifying specific stores “that may have sold a potentially unsafe, recalled food” and is developing a new policy about what information can be made public “to identify a hazardous recalled food.”

DeLauro, who has called for the release of names and locations of retailers and distributors where recalled food was sold, said “too often months go by before retailers take contaminated food off the market, while more and more people fall ill.” Retailers’ delay in taking tainted food off the market “stems primarily from the FDA not exercising its mandatory recall authority,” she said. “The primary mission of the FDA is to ensure the food our families eat is safe, not to protect the trade secrets of food corporations.”

Tony Corbo, a senior lobbyist for the nonprofit Food & Water Watch, said the CDC works with the FDA when there is a multistate food-borne illness outbreak and relies on state agencies to determine whether it was caused by a specific food. “Sometimes, that takes time,” and, if the CDC has been unable to identify the source of the contamination, it is difficult for the FDA to ask for a recall, he said.

During the most recent outbreak, the CDC’s laboratory finding of an E. coli strain related to the one found in Canada “suggests that the infections are caused by the same source but is not enough to prove a link,” said CDC spokeswoman LaKia Bryant.

Regardless of the facts in the recent outbreak, Corbo said the FDA needs to improve its recall process and agreed with the inspector general’s report.

In the 30 recalls analyzed by the inspector general, the average time to initiate a recall was 57 days. Initiation ranged from nine days to 303 days after the FDA learned a product was potentially hazardous.

The FDA was aware for 161 days that various nut butter products made by an Oregon company, nSpired Natural Foods, were contaminated from salmonella before the company agreed to recall its products in 2014, the inspector general’s report said. At least 14 people, including at least one in Connecticut, became ill from the products which were sold under the Kroger, Safeway, Whole Foods and Trader Joe’s brands.

The report contains nothing “surprising,” said Lora Rae Anderson, a spokeswoman for the Connecticut Department of Consumer Protection.

“The FDA is part of a massive organization and has the difficulties inherent in any organization so large,” Anderson said. “Nimbleness and completion have been problems as documented in the report.”

To learn about E. coli and what you can do to lower your risk of infection click here.

Glyphosate, the active ingredient in the world’s top-selling weed killer, Roundup, is a suspected carcinogen that’s used in agriculture, on golf courses, ballfields and other public venues, and for lawn care, experts said. It can be found in more than 750 products sold in the U.S., reports the National Pesticide Information Center.

Health concerns have been raised about Roundup for decades, concerns consistently disputed by its manufacturer, Monsanto. Earlier this year, a group of environmental health scientists called for the federal government to reassess whether glyphosate is a cancer risk.

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Glyphosate can be found in more than 750 products in the U.S.

The New York- and Connecticut-based Citizens Campaign for the Environment supports glyphosate “restrictions or prohibitions,” said Connecticut program director Louis Burch.   Glyphosate poses a risk to young children “due to their rapidly growing bodies and developing immune systems,” he said. It also hurts aquatic life and can harm bees and other pollinators, he said.

The U.S. Environmental Protection Agency limits glyphosate residue content in food and in the amount workers can be exposed to. Calling the limits inadequate, critics say the U.S. Food and Drug Administration—which is mandated to enforce those limits on many foods—has failed to do its job.

The Government Accountability Office reported in 2014 that the FDA doesn’t test “for several commonly used pesticides,” including glyphosate, “the most used agricultural pesticide.”

FDA spokeswoman Megan McSeveney said that because of the cost of the tests, the agency “has not routinely” looked for glyphosate. In 2016, the development of a “streamlined” method allowed the FDA to start testing for residues in soybeans, corn, milk and eggs. The analyses were put on hold for a few months when testing was transferred to new laboratories but resumed this year, McSeveney said.

Preliminary results of the new tests, which were presented at a conference last year, showed no violations for glyphosate residues, but the testing continues. All results “must go through the FDA’s quality-control process to be verified,” McSeveney said.

Monsanto says glyphosate has been used by farmers, homeowners and others for more than 40 years and, if used properly, “does not present an unreasonable risk of adverse effects to humans, wildlife or the environment.”

In July, however, California added glyphosate to its list of chemicals known to cause cancer. The move follows a 2015 determination by the World Health Organization’s International Agency for Research on Cancer that glyphosate was “probably carcinogenic to humans.”

In Connecticut, a bill to ban the use of herbicides on highway medians and railroad rights of way won environment committee approval, but was not voted on by the end of the legislative session.

Lori Brown, executive director, Conn. League of Conservation Voters.

Glyphosate is a “dreadful substance” that has hurt consumers, applicators, wildlife and the environment, said Lori Brown, executive director of the Connecticut League of Conservation Voters. She said she supports action at every level of government to do “whatever it takes to get it out of the environment.”

U.S. Sen. Richard Blumenthal said he’s “concerned with the growing body of evidence linking glyphosate to serious health problems, including cancer.

“I would support a limitation or ban on the use of glyphosate and encourage further investigation into its potentially devastating effects,” he said.

The Northeast Organic Farming Association of Connecticut, referring to glyphosate as a “chemical poison,” says more than 100 million pounds are applied annually on U.S. food crops.

But the Connecticut Environmental Council, which represents golf course superintendents, pest control companies and groundskeepers, said if instructions on the product’s label are followed, it has no concerns about the safety of glyphosate.

“I consider it a valuable tool in controlling weeds such as poison ivy and grass along fence lines,” said Michael Wallace, the group’s president.

North Haven-based Environment and Human Health, Inc.,—a group of doctors and public health professionals—said glyphosate shouldn’t be sold to everyone who walks into a store to buy it.

“The public has been using this product for years and been told it was safe, but scientists are now finding out it is dangerous to human health,” said Nancy Alderman, the group’s president.

“Industry is still claiming, as they always have, that it is perfectly safe, and there is a whole population of people unaware of the product’s health hazards. Roundup should become a restricted pesticide that would require a pesticide permit to use it,” Alderman said.

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Nancy Alderman, president, Environment and Human Health, Inc.

Last year, scientists representing the Food and Agriculture Organization of the United Nations and WHO reported that “there is some evidence of a positive association between glyphosate exposure and risk of non-Hodgkin lymphoma,” but “the only large cohort study of high quality found no evidence of an association at any exposure level.” They also said “glyphosate is unlikely to pose a carcinogenic risk to humans from exposure through the diet.”

Monsanto, which says WHO’s cancer research agency “overlooked decades of thorough and science-based analysis by regulatory agencies around the world,” has also been hit with hundreds of lawsuits by individuals who say the multinational corporation failed to warn that exposure to Roundup could cause non-Hodgkin lymphoma, a cancer that starts in white blood cells.

Monsanto spokeswoman Charla Lord said, “No other pesticide has been more extensively tested than glyphosate.” Regulatory authorities in the U.S. and other countries “have publicly reaffirmed that glyphosate does not cause cancer,” she said, and “the “overwhelming conclusion of experts worldwide, including the Environmental Protection Agency, has been that glyphosate can be used safely according to label instructions.”

But Burch, of the Citizens Campaign for the Environment, said the group will continue to push for limits on the use of chemical pesticides and herbicides. “Our members continue to be concerned about [their] unintended effects.”

Despite the violations, the state Department of Energy & Environmental Protection (DEEP) fined only two of the 29 companies found to be in noncompliance with their permits—a record that state environmental advocates called alarming, but that the agency said is justified.

The 29 companies discharged excessive amounts of pollutants during at least one three-month period from October 2013 to September 2016. At least 19 companies exceeded by more than 100 percent the amounts they were allowed to discharge, according to the U.S. Environmental Protection Agency (EPA) data.

The data also show that 23 of the 60 companies were found in noncompliance with terms of their permits for at least half of the three years—for reasons ranging from excessive discharges to submitting late discharge reports. Thirteen companies were found in significant noncompliance—the most serious level of violation—for three months or more.

While DEEP has the authority to fine or take court action against polluters, EPA records show it more commonly issues notices of violation or noncompliance or warning notices, opting to work with violators for months or years to correct the problems.

Oswald Inglese, DEEP’s director of water permitting and enforcement, said that while the agency receives and generates a large volume of compliance monitoring information monthly, reviewing all the information with limited resources “far exceeds the capacity of department staff.”

Only two companies, Allnex USA of Wallingford and ReEnergy Sterling, were fined for violations of their National Pollutant Discharge Elimination System (NPDES) permits over the three-year period. DEEP levied a $52,000 fine in 2014 against Allnex, which discharges into the Quinnipiac River, and a $45,000 fine in 2014 against ReEnergy Sterling, which discharged into the Moosup River.

State environmental groups say DEEP needs stronger enforcement instead of allowing companies to remain in noncompliance for months or years. The groups say DEEP should fine companies immediately. The lax enforcement, the groups say, results in the pollution of some of the state’s most popular waterways, such as the Connecticut, Naugatuck, Housatonic, Thames and Quinnipiac rivers.

“The record of noncompliance with NPDES permits in Connecticut is extremely disturbing,” said Margaret Miner, executive director of Rivers Alliance of Connecticut. “While some of the violations are undoubtedly minor, some are serious, and all deserve scrutiny.”

“Personally, I think if companies are blatantly and maliciously disobeying the law, they should face consequences, regardless of what the state’s budget situation is,” said Rep. James M. Albis, D-East Haven, the House deputy majority leader. “The reality is that we need enforcement and compliance staff to ensure that this is happening, and in difficult budget times, these types of staff tend to be on the chopping block, or positions are not filled after retirements.”

Inglese said the agency uses computer algorithms to determine which companies are in significant noncompliance and then investigates whether an enforcement response is warranted. The agency often works with violators to determine why they are noncompliant and to get them into compliance.

“Any violation is grounds for enforcement action, but that does not mean that all noncompliance is immediately actionable or always subject to formal enforcement and penalties,” Inglese said.

Companies found in noncompliance for many months or years are not automatic candidates for fines, he added. “Case-by-case circumstances vary and must be evaluated based on their specific situations.”

He said companies may be noncompliant while implementing “a long-term plan to reduce or eliminate noncompliance,” or because of an error on a permit application or “external impediments” beyond their control. Some companies have been involved in bankruptcy proceedings or facility shutdowns that leave behind unresolved environmental problems, he said.

DEEP’s enforcement response “is primarily focused on occurrences of significant noncompliance,” Inglese said. “Those that are not considered significant noncompliance are recorded and noted for further evaluation and possible action at any time in the future.”

The federal Clean Water Act prohibits companies except those holding NPDES permits from directly discharging pollutants through a “point source”—such as a pipe, ditch, channel or tunnel—into a body of water.

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Allnex of Wallingford was fined $52,000 for violations of its wastewater permit in 2014.

The permits limit what kinds of materials can be discharged and their amounts, and set monitoring and reporting requirements to ensure that the discharge does not contaminate the water and impact public health. Industrial permit holders are required to self-report discharge data monthly to DEEP, which provides the data to the EPA. The EPA segments the data quarterly so that noncompliance in a single month is reflected as noncompliance for an entire quarter.

Under the Clean Water Act, any noncompliance is considered a violation and grounds for enforcement or loss of a permit.

Four industrial permit holders—Connecticut Galvanizing of Glastonbury, UniMetal Surface Finishing in Thomaston, Plainfield Renewable Energy in Plainfield and the U.S. Navy’s submarine base in Groton—were found in noncompliance every quarter from October 2013 to September 2016, the data show. None were fined by DEEP.

Connecticut Galvanizing, which discharges into the wetlands of Hubbard and Salmon brooks, was issued a violation notice in 2012 and two more in 2014, Inglese said. By mid-2014, DEEP “escalated the matter into a mediation effort between Connecticut Galvanizing and other involved parties” to allow the company to install a storm water treatment system required by its permit, he said.

In all of 2015 and 2016, Connecticut Galvanizing discharged much more copper, lead and zinc than its permit allowed, but it was not issued a violation notice. In late 2015, for example, the company discharged storm water runoff into Salmon Brook that contained 223,000 percent more zinc and 1,980 percent more lead than allowed.

“All parties were aware of Connecticut Galvanizing’s noncompliance, so the issuance of further notices of violation was viewed as redundant,” Inglese said.

Connecticut Galvanizing paid a $45,000 fine to the federal government and nearly $150,000 to the Farmington River Watershed Association to settle a lawsuit brought by the Environment Connecticut and Toxins Action Network, under the Clean Water Act in October 2016.

Connecticut Galvanizing did not respond to requests for comment.

UniMetal, a metal finisher of parts for the aerospace, automotive and other industries, was in significant noncompliance in 2016, according to the EPA data. The company discharged 293 percent more cyanide, 40 percent more copper and 16 percent more nitrogen into the Naugatuck River than its permit allows.

Two DEEP violation notices remain open in that case, Inglese said. The company hired technical consultants to determine the cause of the noncompliance and is undergoing a toxicity identification and reduction evaluation, he said.

UniMetal President George LaCapra Jr. said the company “has a long history of being a responsible steward of the community and highly respects the waters of Connecticut.”

He said the company is cooperating with DEEP “on how to best meet our current and future NPDES permit obligations.”

Plainfield Renewable Energy, which discharged into the Quinebaug River, was issued two violation notices in 2014 “for sampling and reporting errors and multiple effluent violations” in 2013 and 2014, Inglese said. The noncompliance has since been resolved.

Plainfield Renewable Energy was “a distressed asset,” and most of its violations occurred before it was purchased in July 2015 by Greenleaf Power, said Matt Ross, a spokesman for Greenleaf Power, which owns and operates biomass facilities in the United States and Canada.

Since taking over operations, there have been only four minor permit issues, Ross said. “All issues have been reported and addressed, and, in each case, did not rise to the level of regulatory enforcement,” he said.

The Navy submarine base in Groton had multiple effluent violations and discharged oil and grease far above its permitted limits into the Thames River. The submarine base discharged 100 percent more oil and grease in July-September 2016, and 690 percent more oil and grease in July-September 2015.

The submarine base did not immediately respond to repeated requests for comment. On April 6, Chris Zendan, public affairs officer, wrote in an e-mail, “As CT DEEP noted, case-by-case circumstances, related to an activity’s noncompliance for many months or years, can vary and must be evaluated based on their specific situations. The base is dedicated to being a good steward of the environment and works diligently with the EPA and CT DEEP to that end.”

He wrote, “In this effluent case…SUBASE believes the findings may be in error and has been investigating the issue with DEEP since late 2015.”

Eight companies were found in noncompliance in 10 to 12 quarters from October 2013 to September 2016, the data show. Shelton-based Autoswage Products, for example, was found in noncompliance in 10 quarters, including the last quarter of 2013, when it discharged 517 percent more copper and 58 percent more iron into the Housatonic River than its permit allowed.

Vern Williams Photo.

Autoswage of Shelton discharged more copper and iron into the Housatonic River than allowed in 2013. It no longer has a discharge permit.

Autoswage President Keith Brenton said the company, which manufactures contact and connector pins, recently emerged from bankruptcy and has no plans to discharge wastewater in the future. The DEEP says it denied renewal of Autoswage’s discharge permit, and the company has not discharged since December 2013.

Allnex, one of the two companies fined over the three years, is a manufacturer of coating resins. Records show it discharged 258 percent more aluminum than allowed in 2014, and 3,020 percent more acrylonitrile than allowed in 2015. Acrylonitrile is a poisonous compound used widely in the manufacture of plastics, adhesives and synthetic rubber.

Frank DiCristina, Allnex’s site manager in Wallingford, said that since 2013, the company has embarked on “a systematic program to ensure the highest level of environmental compliance and voluntary improvement beyond compliance.”

DiCristina says Allnex reduced toxic emissions by 80 percent from 2012 to 2015, installed a new operating control system for its wastewater treatment plant, and implemented a community advisory board comprised of local citizens, conservation groups and others.

But EPA records show that, after the company was fined in 2014, DEEP found subsequent effluent violations and issued a notice of violation in March 2015. Allnex provided “an adequate response,” Inglese said, and the notice of violation was closed three months later. Records show Allnex was out of compliance in every quarter of 2015, including two after the notice of violation was closed, and the first three quarters of 2016.

ReEnergy Sterling was fined for discharging polluted storm water and groundwater into the Moosup River “on various occasions,” and failing to “properly operate and maintain their storm water retention basin,” according to DEEP. ReEnergy Sterling was a waste-to-energy facility that used waste tires as a fuel source.

Sarah Boggess, a spokeswoman for ReEnergy Holdings, said the Sterling energy plant was shut down in October 2013 and sold in September 2016. The fine related to a higher amount of zinc than allowed in storm water during a rainstorm when the plant was shut down for repairs in December 2011, she said.

Roger Reynolds, the legal director of Connecticut Fund for the Environment/Save the Sound, said companies found in noncompliance should be immediately fined and not given months to comply. Reynolds said his group conducts its own investigations of violations, and if appropriate, will file suit against violators.

He said DEEP is staffed by “good people” who are “radically under-resourced,” and “don’t do a whole lot of enforcement.”

DEEP officials say that many rivers, streams and lakes are now cleaner than they have been in the past 100 years, and that once badly polluted rivers, such as the Willimantic, Naugatuck, Pequabuck, Quinnipiac, Connecticut and Farmington, are now used for many recreational pursuits.

Miner, of the Rivers Alliance, said more work needs to be done, pointing out that only 30 percent of accessible river miles in Connecticut meet Clean Water Act standards for swimming and fishing.

Eight states, including Vermont and Maine, now have laws prohibiting or limiting the weaponization of drones, and Connecticut is expected to take up a similar ban in the next legislative session. A proposal in Connecticut to make it a felony to carry a weapon or an explosive in a drone was approved by the House during the 2016 legislative session, but the Senate failed to take action.

“Hopefully, next year, we will get the legislation across the finish line,” said Rep. Stephen Dargan, D-West Haven, co-chair of the legislature’s Public Safety and Security Committee.

YouTube.

Drones with flamethrowers like this one built by Austin Haughwout would be banned in CT.

Nationally, there were 632,068 drones registered as of December, according to Alison Duquette, a spokeswoman for the Federal Aviation Administration (FAA). In Connecticut, a C-HIT analysis of the FAA’s most recent state-by-state database reveals that 5,731 drones were registered as of May.

Connecticut has been at the center of the drone controversy since the videos by Haughwout made national news, spurring investigations by the Clinton police and the FAA. No charges were brought against Haughwout and his father, Bret Haughwout, but the two men are expected to disclose information under oath about their use of weaponized drones before the FAA in the coming months, their attorney said. The men initially refused to comply with federal subpoenas to disclose information, but U.S. District Court Judge Jeffrey Meyer ruled in July that they must comply.

Their attorney, Mario Cerame, said he is prepared to contest any enforcement action or fines against his clients. He argues that the Haughwouts’ drone flights occurred before the FAA established in August specific regulations pertaining to drones.

Agency regulations prior to August, he said, were intended to apply to traditional aircraft with pilots —including airplanes, helicopters and blimps—and not to small, unmanned aircraft like drones.

An FAA spokesperson, Les Dorr, says that while the agency cannot discuss pending litigation, the FAA has the authority to “take enforcement action against anyone who operates an aircraft in a careless or reckless manner” and to levy fines against violators.

Many people fly drones for pleasure, and businesses and government agencies use them for numerous purposes, including assessment of farm crops, power lines, road conditions and storm damage. The FAA expects annual drone sales to jump from 2.5 million this year to 7 million in 2020.

“Civilian drones are incredibly useful devices that can and will improve our everyday lives,” Peter Sachs, a Connecticut lawyer and drone advocate, said. “Weapons are intended to cause damage, injury and even death. Attaching any sort of weapon to a civilian drone serves no useful purpose and does nothing to improve our lives.”

State Legislatures Get Involved

As drone popularity soars, lawmakers in New England and other states are expressing concerns about the dangers of civilians, and in some instances, of law enforcement officials, using weaponized drones.

Nevada, North Carolina, Oregon, Vermont, Wisconsin, Maine, North Dakota and Virginia have laws addressing weaponization of drones, said Amanda Essex, a policy associate at the National Conference of State Legislatures.

Five states, Nevada, North Carolina, Oregon, Vermont and Wisconsin prohibit possession or use of a weaponized drone by anyone. Maine and Virginia prohibit weaponized drones for use by law enforcement or public agencies. North Dakota prohibits law enforcement from attaching lethal weapons to drones, but the state’s law doesn’t address Tasers, tear gas or any other weapon considered non-lethal.

In Connecticut, the Senate “never got a chance” to vote on a proposed drone bill because budget deliberations took up too much time, said Sachs, who worked with Connecticut lawmakers on the bill. “The upcoming session will be different, and it will pass. No one in the legislature is opposed to it,” he said. The bill that failed included a provision to allow law enforcement bomb squads to equip drones with explosive detection, detonation or disposal equipment.

Paul Fitzgerald, the Connecticut Police Chiefs Association’s legislative committee co-chair and Berlin’s police chief, says the state’s police chiefs plan to draft a policy that will not allow weapons of any kind on any drones used by law enforcement. It will be based on a policy that was developed by the Virginia-based International Association of Chiefs of Police and will be shared with the state legislature, Fitzgerald says.Weaponization issues aside, Fitzgerald says drones “can be a great tool in the future to help with search and rescue, traffic investigation, crime investigation and event security.”

The American Civil Liberties Union of Connecticut supports legislation to prevent police from weaponizing drones, says the group’s spokeswoman, Meghan Smith.

“Drones have a legitimate place in some law enforcement operations, such as search and rescue efforts or accident scene recreation,” Smith says. “Given their immense capabilities for surveillance and weaponization, however, we strongly support requiring police to get a warrant before using them for spying and preventing police from attaching weapons to them.”

The new FAA regulations that went into effect in August make no mention of weapons but prohibit drones from carrying “hazardous materials” or operating in a “careless or reckless manner.” The rules also state that “no person may allow an object to be dropped from a small unmanned aircraft in a manner that creates an undue hazard” to people or property.

“The FAA is concerned about anything that can impact aviation safety,” says Alison Duquette, a spokeswoman for the agency. “We work with local, state and federal law enforcement agencies to investigate unauthorized or unsafe unmanned aircraft systems operations.”

FAA rules state that drones must weigh less than 55 pounds, must stay in the line of sight of the operator and can reach a maximum ground speed of 100 mph. Maximum allowable altitude is 400 feet above the ground, but a drone can ascend higher if it is within 400 feet of a structure.

All drones, including model aircraft used by hobbyists, must be registered with the FAA. Drones that are not model aircraft must be operated by someone with a remote pilot airman certificate or under the direct supervision of a person with such a certificate.

Since the drone incidents, Austin Haughwout has been arrested twice. In October, he was charged with fourth-degree sexual assault, enticing a minor and risk of injury to a minor. In July, Clinton police charged him with possession of child pornography, risk of injury to a minor and criminal attempt to commit sexual assault in the fourth degree.

The infant’s grandfather, Rickie Hanes of North Haven, on behalf of the baby’s estate, is suing the hospital and the supplement manufacturer, Solgar, and its parent company NBTY.

Yale New Haven, Solgar and NBTY argued in court in August that various claims against them—including reckless disregard for safety and fraudulent misrepresentation of a product’s safety—should be eliminated.

Angelo Ziotas, an attorney representing the Lee-White estate, says a written ruling by New Haven Superior Court Judge Steven Ecker will likely come by the end of December, and the judge has set June 2017 as the date to complete discovery and fall 2018 as the trial date.

Lee-White, the son of Samantha Pineapple Lee and Aaron White, was born prematurely by C-section on Oct. 3, 2014, at Yale New Haven and died eight days later.

The lawsuit alleges that Lee-White was given contaminated probiotic ABC Dophilus Powder on several occasions during feedings at the hospital. The powder—a dietary supplement that Solgar claimed contained beneficial bacteria—was contaminated with a fungus, Rhizopus oryzae, when it left the company’s Leonia, N.J., manufacturing facility, the suit alleges.

Lee-White’s mother, father and grandmother, Betty White, saw bulges in the baby’s stomach after he was first “poisoned” by the powder, but were told by hospital staff that the bulges were related to the infant’s prematurity, according to the lawsuit.

Ziotas says he and relatives of Lee-White will not comment about the lawsuit.

Dana Marnane, public relations director for Yale New Haven Health System, says “the death of a child is tragic, and our deepest sympathies go out to the family. The hospital is aware that the FDA reported on Nov. 14, 2014, Solgar Inc. voluntarily recalled ABC Dophilus Powder.  This product was used at YNHH at the time.  Any allegation directed to the hospital in the complaint will be defended.”

In November 2014, U.S. Food & Drug Administration scientists confirmed the presence of Rhizopus oryzae, a mold species, in unopened containers of ABC Dophilus Powder at the hospital.

The infant, according to the FDA, “suffered from gastrointestinal mucormycosis,” a fungal infection. The U.S. Centers for Disease Control and Prevention determined that mold caused the mucormycosis.

The FDA alerted healthcare providers in December 2014 about the risks of using dietary supplements formulated to contain live bacteria or yeast in people with compromised immune systems. The agency encouraged providers who use dietary supplements containing live bacteria or yeast as drugs—“to treat, mitigate, cure or prevent a disease or condition” —to submit an investigational new drug application for FDA review.

Jodi Katz, NBTY’s director of corporate communications, says Solgar completed “its ABC Dophilus product investigation in collaboration with the CDC and the FDA.”  The investigation, she says, thoroughly examined the product’s “supply chain under Solgar’s control”—the source of the raw materials, the manufacture and packaging of the ABC Dophilus powder and its transportation and delivery to the hospital pharmacy where is was dispensed.

“After numerous facility and equipment inspections, the diligent review of relevant standard operating procedures and the robust testing of hundreds of product samples by the FDA, CDC, industry-leading independent third-party laboratories and Solgar, Solgar can confirm that the contaminant at issue was not identified at any point within the product’s supply chain under Solgar’s control,” Katz says.

No other “serious adverse events” were reported “for any other ABC Dophilus product originating from the same manufacturing lot of the implicated product, including other ABC Dophilus products from the same manufacturing lot that had been dispensed by the same hospital pharmacy,” Katz says.

Last year, U.S. Sen. Richard Blumenthal, D-Conn., told C-HIT that Lee-White’s death underlines the need for better oversight of the dietary supplements industry. Blumenthal called the dietary supplement marketplace “a dangerous Wild West of inadequate regulation” that deprives consumers “of basic health and safety information” and results “in serious injuries and deaths.”

Many adults ingest dietary supplements, which the FDA defines as vitamins, minerals, herbs, extracts and other products “that aim to add nutritional value to a diet.” Unlike drugs, which are subject to FDA approval, companies can manufacture and sell supplements without the agency’s approval.

A C-HIT analysis last year revealed that every week since Jan. 1, 2008, the FDA has identified an average of two dietary supplements being sold to consumers that were “tainted” and “potentially hazardous.”

Industry leaders say that an overwhelming majority of dietary supplements companies sell safe products that include no illegal ingredients and are beneficial to millions of Americans. The FDA has stated that “some supplements are useful in reducing the risk of certain diseases.”

The FDA documents show the five doctors were alerted as part of a wide-reaching federal probe involving Gallant Pharma International Inc., which sold more than $12.4 million in unapproved chemotherapy and injectable cosmetic drugs in the United States before the government shut down the operation in 2013.

The letters to the doctors, dated April 1, 2015, say that “In addition to putting patients at risk, receiving misbranded or adulterated drugs and devices in interstate commerce and delivering or offering to deliver those drugs and devices to (or use on) others violates federal law.”

None of the doctors has been charged with wrongdoing, and only one acknowledged receiving the letter from the FDA.

FDA letter sent to doctors.

The case comes to light as drug companies and pharmacies are urging Congress and law enforcement officials to crack down on an increasing number of dangerous unapproved and counterfeit drugs being sold to doctors and consumers nationwide. Sales of counterfeit drugs and drugs not approved by FDA have soared into a multi-billion dollar industry with the growth of the Internet, and drug companies say efforts by governments to tackle illegal online drug sales are not sufficient.

U.S. Sen. Richard Blumenthal, D-Conn., said the FDA should be referring its Gallant Pharma investigation results to state medical commissions that have “licensing oversight over physicians.”

If the FDA believes a provider violated federal law, “The Department of Justice can take criminal enforcement action in the same manner as when health care providers overprescribe opioids or commit Medicaid fraud,” Blumenthal said. He said he planned to contact the FDA “to determine if there is any need for further Congressional action.”

Gallant distributed more than 17,000 units of unapproved drugs to medical practices in the United States between August 2009 and August 2013, and “it is not known, whether any of the drugs or devices are still in distribution,” the FDA said.

Individuals who ingest fake or counterfeit drugs may be at risk of a number of dangerous health consequences, including unexpected side effects, allergic reactions, or a worsening of their medical condition, according to the FDA.

In a recent briefing to House staffers, Thomas Kubic, who represents 33 drug manufacturers as CEO of the Pharmaceutical Security Institute, outlined the Department of Justice actions against Gallant and other illegal drug sellers.

“Although there have been some enforcement operations, we haven’t seen a decrease in unapproved and counterfeit drugs,” Kubic said, in an interview with C-HIT. “Criminals are making billions of dollars from counterfeits.”

Of the five doctors who were mailed FDA letters, only two would fully discuss Gallant.

Dr. David Kloth, the medical director of Connecticut Pain Care in Danbury, said three or four of his patients with chronic headaches and other “pain syndromes” were denied Botox injections by their insurance carriers in 2011 and wanted to pay on their own for the drug.

“We had heard of a mail-order pharmacy in Canada that would provide them the drug at half the cost ($350 instead of $550 per vial),” Kloth said. Only one of his patients agreed to buy the Botox, he said, and the patient had “no detrimental effects.”

“We stopped using this company because of the difficulties with the process and our concerns about the legality of buying from Canada,” Kloth said.

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More than $699,000 of Gallant drugs and devices were sold to doctors and hospitals in Connecticut and Massachusetts.

Kloth said the drug received from Gallant was the same product—in an identical bottle and packaging—as a more expensive one supplied by Allergan, which sells FDA-approved Botox. The Gallant product, he said, “was made by Allergan, shipped to Canada, and we bought the exact same material but from a Canada distribution pharmacy at a fraction of the cost.”

Dr. Jeffrey Gold, an ophthalmologist at Laser Body Solutions in Hamden who was sent an FDA letter, said he had never heard of Gallant Pharma, didn’t buy drugs from the company and didn’t recall receiving a letter from the FDA informing him that he may have bought drugs from the company. He said he uses Botox made by Allergan.

Dr. Jonathan Kost, the medical director of pain programming at Hartford Hospital, said he hadn’t heard of Gallant Pharma and was unaware of the FDA letter.

Dr. David Feingold of Physical Medicine & Rehab of Hartford, LLC did not respond to repeated requests for comment.

Dr. Matthew Raymond of CT Rehabilitation & Spasticity Care, LLC of Southington also did not respond to repeated requests for comment.

According to a grand jury indictment against one of Gallant’s employees, Patricia Durr of Massachusetts sold more than $699,000 of Gallant drugs and devices to doctors and hospitals in Connecticut and Massachusetts. Also, Durr sold “240 vials of misbranded Botox for $90,000 to a doctor in Southington, Connecticut.” The name of the doctor was not disclosed.

FDA spokesman Chris Kelly said that the agency does not have the authority to monitor doctor-patient affairs and does not know how many patients may have taken or been harmed by the drugs.

Criminal Case Against Gallant

In May 2014, Gallant Pharma co-owners Talib Khan and Syed Huda were sentenced to three years in prison after they and 10 others employed or associated with the company pled guilty to criminal charges.

The FDA in July 2015 permanently debarred Khan, Huda and three others who pled guilty, including Durr. The debarring prohibits them from “providing services in any capacity to a person having an approved or pending drug product application.”

Durr refused comment to C-HIT about drug sales she made in New England.

According to a 2013 grand jury indictment, Gallant Pharma executives working in Virginia had foreign accomplices ship drugs to the United Kingdom and Canada, and then other accomplices in those countries shipped them to Virginia. Many of Gallant’s drugs were subject to strict temperature controls to protect drug potency, but the company, according to the Department of Justice, received and shipped the drugs with ice packs that “sometimes melted—not with dry ice used by legitimate drug distributors.”

Also, many of Gallant’s drugs did not have a FDA-required “black box” warning indicating they could have life-threatening adverse effects, the Justice Department said.

Roger Bate, economist and author.

Roger Bate, an economist and an expert on international health policy and counterfeit drugs, said it’s “extremely vital” that drugs for cancer, epilepsy and some other conditions are “perfectly manufactured” and properly shipped. If not, the drugs “may be fatal or useless,” said Bate, author of “Making A Killing: The Deadly Implications of the Counterfeit Drug Trade.”

Gabriel Levitt, the president of PharmacyChecker.com, says many drugs available in foreign countries are the same ones sold domestically but are much cheaper, or foreign versions of FDA-approved drugs that are safe, effective and less expensive.

Bate and Levitt agree that the FDA needs to identify the safest online pharmacies abroad, as well as crack down on rogue operations. Too often, they say, drug companies and U.S. pharmacies push law enforcement authorities to act and try to maximize profits by lumping together unscrupulous counterfeit drug sellers with sellers of safe, less expensive drugs.

“We are all for cracking down on people selling unsafe, dangerous medications,” Levitt said, “but we are really against conflating those issues with Americans who buy safe, effective medications abroad because they can’t afford them domestically.”

Kloth, the Danbury doctor, said Americans “are being ripped off” by drug prices, and complained that the federal government “does nothing to protect the American people from these exorbitant prices.”

He said he recently bought medication at a pharmacy that cost more than $300, though it cost $10 to produce and was sold for less than $40 several years ago. “Why should the same medication be half the cost in Canada?” he asked.

Blumenthal said consumers should be allowed to buy drugs that are more affordable from foreign pharmacies, but that “very rigorous safeguards” must be in place to protect against unsafe drugs.

The FDA “must aggressively pursue any illegal importation,” he said.

The doctors say that the out-of-pocket costs for insulin, ranging from $25 to upwards of $600 a month, depending on insurance coverage, are forcing many of their low-income patients to choose between treatment and paying their bills.

“Some of my patients have to make the choice between rent or insulin,” said Dr. Bismruta Misra, an endocrinologist with the Stamford Health Medical Group. “So they spread out taking insulin [injecting it less frequently than a doctor has prescribed] or don’t take it.”

Experts and recent studies point to drug companies’ long-standing patents and the lack of generic or “biosimilar” insulin as key reasons why the drug is so expensive.

A study by Philip Clarke, a professor of health economics at the University of Melbourne in Australia, reported that the price of insulin has tripled from 2002-2013. The findings were published in a research letter in the April 5 issue of the Journal of the American Medical Association.

Studies report that the cost of insulin has risen by triple-digit percentages.

In the United States. Just three pharmaceutical companies hold patents that allow them to manufacture insulin: Eli Lilly, Sanofi and Novo Nordisk. Put together, the three made more than $12 billion in profits in 2014, with insulin accounting for a large portion. All three hiked their prices in the last five years by 168 to 325 percent, says Dr. Kasia Lipska, an endocrinologist at the Yale School of Medicine.

A diabetic needing insulin but unable to buy it “ultimately will hit our emergency room,” said Dr. Cunegundo Vergara, who specializes in internal medicine at Hartford Hospital.

Vergara says “plenty” of low-income diabetics in the Hartford area are living without physician-prescribed insulin.

Similarly, in New Haven, Dr. Anne Camp, an endocrinologist at the Fair Haven Community Health Center, said she has seen “many patients referred to me because their diabetes is out of control, and the major reason is that they can’t afford their insulin. Many other patients are prescribed insulin, and they don’t return for a follow-up, because they are too embarrassed to admit they can’t afford it.”

About 257,000 Connecticut adults (8.9 percent) have been diagnosed with diabetes. Hispanics and African Americans are more than twice as likely to have the disease compared with whites and they are at greater risk of dying from diabetes-related causes, according to the latest data from state Department of Public Health. Diabetes was the seventh leading cause of death in Connecticut in 2013, killing 664 people.

The U.S. Centers for Disease Control and Prevention reports that the number of Americans diagnosed with diabetes increased from 5.5 million in 1980 to 22 million in 2014. Type 2 diabetes is the most common form.

The higher rates of Type 2 diabetes among African Americans and Hispanics “appear to be based on a number of factors, including [differences in] access to healthy foods, physical activity and genetics,” said Dana Marnane, a vice president for public relations at Greenwich Hospital. The hospital reported a 19.5 percent increase in patients discharged with diabetes as a primary or secondary diagnosis in fiscal year 2015, compared with 2014.

Diabetes is a disease in which blood sugar levels are higher than normal. Insulin keeps blood sugar from rising too high. Without insulin for an extended period of time, a diabetic increases the likelihood of heart attack, stroke or death.

Lipska, the Yale endocrinologist, criticized pharmacy benefit managers—who negotiate with drug companies on behalf of employer and government insurance programs—for being more focused on accepting rebates from drug manufacturers than on bargaining for lower drug prices.

To make insulin more affordable, Lipska said, more competition is needed among insulin manufacturers, and biosimilar products must be made available for patients in the United States. There also is a need for better pricing transparency and regulation, she said.

Eli Lilly spokeswoman Julie Williams said she could not disclose the average cost to manufacture, package and distribute insulin to each user, because manufacturing and distribution costs are proprietary. Eli Lilly introduced the world’s first commercial insulin in 1923.

A biosimilar product hasn’t emerged from other manufacturers, she said, “because developing and manufacturing insulin requires billions of dollars in investment, along with deep scientific and technical expertise.”

She said the reason people say insulin is expensive “are complex and go beyond the medicine’s list price,” Williams said. “One of the primary reasons is the advent of new insurance plan designs—particularly the increased use of high-deductible health plans, which shift more of the cost to the individual.”

Many low-income Americans get insulin through Medicaid, and in Connecticut Medicaid covers insulin and diabetes supplies at no cost. Lilly offers patient- assistance programs that provide free medicine for one year to low-income patients who meet specific financial qualifications. But Williams acknowledged, “Additional solutions are needed so all patients have access to their medicine.”

Novo Nordisk and Sanofi did not return calls seeking comment.

The American Diabetes Association, which represents 441,000 people, says that no diabetic should go without insulin because of “prohibitive costs or accessibility issues.”   The association says that “many parties, including pharmacy benefit managers, insurers and retailers are involved in the path of medications” from manufacturer to patient. The ADA advocates “transparency by all parties in their pricing policies and a continued dialogue” to develop lasting, affordable solutions.”

At the Fair Haven clinic, many patients turn to discount retailers, such as Wal-Mart, where a cheaper but older type of insulin is sold, Camp said. But many doctors won’t prescribe it because it often isn’t as effective in managing and treating diabetes, Camp said.

The retail cost for a month’s supply for a typical Fair Haven clinic patient who uses 100 units of insulin daily to treat Type 2 diabetes is about $600 to $800, Camp said. And diabetic patients commonly have other health problems, including high blood pressure and high cholesterol that also require medication and treatment.

“What person making $30,000 a year can lay down $600 a month for insulin?’’ asked Camp, whose clinic treats about 16,000 patients annually, 72 percent Hispanic, 20 percent African American and 80 percent below the federal poverty level.

About 25 percent of the clinic’s patients have no health insurance, and those with private insurance often have “enormous deductibles, such as $4,000 a year,” she said.

Fair Haven participates in the federal 340B program, which requires drug manufacturers to provide outpatient drugs to eligible health care organizations at significantly reduced prices.

“In this country,” Camp said, “we have the potential for really good diabetes treatment. Yet, sadly, because diabetes has become such a high-cost condition, many people can’t get access to it.”

Nationally, the number of cases involving all three common sexually transmitted diseases increased for the first time since 2006, the CDC reports.

The 2014 Sexually Transmitted Disease Surveillance Report, which was released in November, shows that, nationally, the number of reported cases of syphilis increased 15 percent over the number reported in 2013. The number of gonorrhea cases rose 5 percent last year, and reported chlamydia cases increased by 3 percent.

Statistics for the state show a slightly different picture. Connecticut last year reported 13,382 cases of chlamydia and 169 cases of syphilis, 607 more chlamydia cases and 36 more syphilis cases than in 2013. Gonorrhea cases fell from 2,860 in 2013 to 2,333 last year.

“For all three diseases, Connecticut’s rates are below the national average,” says Dr. Lynn Sosa, deputy state epidemiologist with the Department of Public Health.

According to the CDC, Connecticut last year ranked 40th of the 50 states in the number of reported chlamydia cases per 100,000 residents. The state ranked 37th in gonorrhea cases and 37th in primary and secondary syphilis cases.

Sosa says there are many reasons for the big increase of chlamydia cases last year, including advances in tests to diagnose chlamydia and more efforts to increase screening of persons at risk.

Sexually active women younger than 25 years old are encouraged to have annual screenings, she says.

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Syphilis cases in CT increased last year.

As in other regions of the country, there is a wide disparity in Connecticut in the rate of sexually transmitted diseases among races and ethnicities.

The rates of reported cases of chlamydia and gonorrhea are five times higher for Hispanic residents than for white residents in Connecticut, Sosa says. For African American residents, the rate of reported chlamydia cases is nearly 17 times higher than the rate for whites and 24 times higher for gonorrhea.

Nationally, the CDC reports, the gonorrhea rate among Hispanics last year was 73.3 cases per 100,000 population; nearly double the rate among whites. The rate of chlamydia and primary and secondary syphilis among Hispanics was also double the rate among whites.

Hartford and New Haven last year reported the most chlamydia and gonorrhea cases in the state. There were 1,666 chlamydia and 398 gonorrhea cases in Hartford and 1,400 chlamydia and 250 gonorrhea cases in New Haven.

In both cities last year, the numbers of chlamydia and primary and secondary syphilis cases increased over the 2013 numbers, while the number of gonorrhea cases decreased. The increase of chlamydia cases in Hartford was small — seven more than in 2013.

Hartford reported the most primary and secondary syphilis cases last year — 13. New Haven, Bridgeport and Waterbury tied for the second-highest total — each reporting 11.

In Connecticut’s most populous city, Bridgeport, the city’s communicable disease clinic has seen a slight increase in syphilis cases but a stable number overall of sexually transmitted diseases, according to Kristin duBay Horton, the director of health at the Bridgeport Health Department.

Horton said that the number of patient visits to the clinic has decreased, likely as a result of the Affordable Care Act, which has provided people with health insurance and created more health care options.

To reduce the likelihood of contracting a sexually transmitted disease, Connecticut residents should use condoms and have safer sex practices, including limiting the number of partners and having partners tested, Horton says.

There’s been an increase in the number of people using PrEP (pre-exposure prophylaxis) — a pill to prevent HIV infection — and these people “are less likely to use condoms and follow other preventative measures,” she says.

Dr. Jonathan Mermin, the director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention, says sexually transmitted diseases particularly affect young women and men, but the agency’s new data suggest “an increasing burden among gay and bisexual men.”

Primary and secondary syphilis among men who have sex with men has been increasing since at least 2000, the CDC says. More than half of men who have sex with men and were diagnosed with syphilis last year were also HIV-positive, the agency says. Infection with syphilis can cause sores on the genitals, which make it easier to transmit and acquire HIV.

Syphilis is currently the only STD for which information on the gender of the sex partner is reported. The CDC reports that a growing body of evidence indicates that men having sex with men are experiencing similar increases in gonorrhea and chlamydia infections, underscoring the need to further understand what is contributing to the increase.

The CDC recommends screening at least once a year for syphilis, chlamydia and gonorrhea for all sexually active men who have sex with men.

The agency says the most reliable way to avoid sexually transmitted diseases is abstinence. Another effective strategy for reducing the risk is mutual monogamy, which, according to the CDC, “means that you agree to be sexually active with only one person, who has agreed to be sexually active only with you.” The CDC also recommends vaccinations to prevent hepatitis B and HPV (human papillomavirus). Vaccines for males and females can protect against some of the most common types of HPV, which are spread by sexual contact. The CDC recommends three vaccination shots before becoming sexually active.

The supplements contained prescription drug ingredients, controlled substances or untested pharmaceutical ingredients, which is prohibited by federal law and “can pose considerable dangers to consumers,” including stroke, liver damage, kidney failure and death, according to the FDA.

Annual sales of dietary supplements reached $35 billion.

C-HIT’s analysis of FDA data reveals 615 dietary supplements that were identified as tainted since Jan. 1, 2008. In the first half of this year alone, 59 tainted dietary supplements were posted on the FDA’s site.

In July, the U.S. Department of Justice took court action against two supplement companies in Montana and Iowa for illegally selling or distributing prohibited or misbranded products. While some violations prompt legal action, regulators acknowledge that they are overmatched in their ability to monitor the supplements.

The FDA says the tainted supplements in its database are a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the Internet and in retail establishments.

U.S. Sen. Richard Blumenthal, D-Conn., is calling for a crackdown on the dietary supplements industry. He is working with U.S. Sen. Dick Durbin, D-Ill., to reintroduce the Dietary Supplement Labeling Act, which, Blumenthal says, would help consumers distinguish between supplements that are safe and those that may have serious side effects or drug interactions. The bill would require more information on product labels and give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health-benefit claims.

“The dietary supplement market is a dangerous Wild West of inadequate regulation” that deprives consumers “of basic health and safety information” and results “in serious injuries and deaths.” Blumenthal says. “Without more transparency regarding the dangers of these products—and more scrutiny over the often outrageous health benefit claims—consumers simply have no way to know what they are taking.”

Industry leaders say, however, that an overwhelming majority of companies sell safe products that include no illegal ingredients and are beneficial to millions of Americans.

Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade group that represents supplement manufacturers, says the 150 “legitimate, mainstream” companies in his organization are responsible for a majority of industry sales and are committed to quality products and compliance with federal regulations.

Most adults ingest dietary supplements, which the FDA defines as vitamins, minerals, herbs, extracts and other products “that aim to add nutritional value to a diet.”

During the past 15 years, the industry has exploded in popularity, pushing annual sales to $35 billion, according to the trade group. About 150 million adults nationally, or 7 out of every 10, ingest dietary supplements, the organization says. The supplements are sold in various forms, tablets, capsules, powders, energy bars and liquids.

Unlike drugs, which are subject to FDA approval, companies can manufacture and sell supplements without the agency’s approval. The FDA can take action if a dietary supplement contains undeclared ingredients, is found unsafe or if there are false or misleading claims about it.

Concerns about the safety of dietary supplements were raised after a pre-mature infant died in October 2014 in a Connecticut hospital after being treated with a probiotic supplement that was found to contain mold. In November, FDA scientists confirmed the presence of a mold species, Rhizopus oryzae, in unopened containers of Solgar ABC Dophilus Powder, which had been collected at the Connecticut hospital where the infant died. The FDA did not reveal the name of the child or the hospital.

According to the FDA, the infant “suffered from gastrointestinal mucormycosis,” a fungal infection, and the U.S. Centers for Disease Control and Prevention determined that mold caused the mucormycosis.   Both agencies issued warnings following the infant’s death.

“The contaminant at issue was not identified at any point within the product’s supply chain under Solgar’s control,” says Andrea Staub, a spokeswoman for NBTY, the company that owns Solgar.

Staub says the findings were determined after “numerous facility and equipment inspections,” a review of operating procedures and tests of product samples by the FDA, CDC, independent laboratories and Solgar.

Blumenthal says the infant’s death underlines the need for better oversight of the supplements industry.

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Sen. Blumenthal is calling for a crackdown on the dietary supplement industry.

The FDA states that “some supplements are useful in reducing the risk of certain diseases” and can make related claims on their labels. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.

Dietary supplements “are not intended to treat, diagnose, cure or alleviate the effects of diseases,” according to the FDA.

Mister says small companies, particularly many that sell their products on the Internet, are giving the industry a bad rap. The “fringes of the industry” sell products they call dietary supplements to “get them under the FDA’s radar screen” but include anabolic steroids or other illegal drugs, Mister says.

Supplements marketed for weight loss, bodybuilding and sexual enhancement, which are often labeled as “all natural,” are the most frequent violators, the FDA says.

C-HIT’s analysis of another FDA database found numerous warning letters sent in recent years to dietary supplement manufacturers, including four in Connecticut. Warning letters are issued for significant violations that “may lead to enforcement action if not promptly and adequately corrected.”

In July 2014, the FDA issued a warning letter to Klein Laboratories after inspecting its manufacturing facility in North Haven. The label for the company’s bodybuilding product, Osteojuv, “revealed serious violations” of federal regulations, including claims that it targets pain and inflammation, according to the FDA. Klein Laboratories did not respond to a request for comment.

In May 2012, a warning letter was sent to Middletown-based NatureMost of New England because its C-Complex tablets “failed to establish” required “component specifications for identity, purity, strength and composition.

The company’s CEO, Robert Trigo, says his “products have always been above board,” and “it’s very easy to get a warning letter” for many reasons. He says the product was discontinued.

A May 2011 warning letter was issued to Farmington-based Prostar after FDA inspectors “found a number of violations” of manufacturing regulations, including Prostar’s “release” of two bodybuilding products, Ultra Ripped capsules and Higher Power 100% Whey Power protein shake, before product testing was completed and reviewed.

Brian Rubino, Prostar’s vice president, said that the company submitted a corrective action plan that the FDA approved.

In February 2011, the FDA issued a warning letter to Middletown-based RHG 7 Company, which operates under the name Vital Nutrients. The agency said the company’s four supplements were “prepared, packed or held under conditions” that did not meet federal regulations. In 2008, the FDA also sent a warning letter to the company pointing out its DMSA dietary supplement was a drug.

Sarah Roller, a lawyer representing Vital Nutrients, said the company “promptly and successfully” resolved both matters. After the 2011 warning letter, Vital Nutrients “knuckled down” and was told by the FDA that it was in compliance with federal regulations. After the 2008 warning, the company “immediately discontinued” use of DMSA and hasn’t used the ingredient since, she says.

In the last eight months, the FDA has acknowledged that two generic versions of the attention-deficit/hyperactivity disorder drug Concerta it approved may not work as effectively as the brand-name product. The agency told the drugs’ manufacturers to confirm their effectiveness or withdraw them from the market.

The FDA also is looking into findings by a researcher at Boston’s Brigham and Women’s Hospital that generic versions of Pfizer’s cholesterol-lowering drug Lipitor manufactured outside of the U.S. contains impurities that inhibit the drug’s therapeutic effect.

The FDA said that, as a number of popular drugs come off patent through 2015, it lacks the resources to independently police generics.

“FDA is aware that there are reports noting that some people may experience an undesired effect when switching from a brand-name drug to a generic formulation or from one generic drug to another generic drug,” the agency states on its website. The FDA “is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur.”

The website adds, “The agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies.”

The FDA’s lack of resources worries some policymakers and researchers. The most recent statistics show the agency approved 154 new generic drugs in the first five months of fiscal year 2015. It approved 409 new generic drugs in fiscal year 2014.

“The FDA is grossly underfunded and needs greater investments in order to ensure consumer safety,” said U.S. Rep. Rosa DeLauro, who represents the 3^rd Congressional District and is a former chairwoman of the agriculture appropriations subcommittee, which funds the FDA.

Brigham and Women’s researcher R. Preston Mason said that generic drugs “may suffer from poor quality or may not be as beneficial for patients” as the brand-name drugs.

More than eight in 10 prescriptions in the U.S. are filled using generic drugs, which provide cost savings over brand-name products. The Affordable Care Act, enacted in 2010, gives consumers more access to generic drugs, and the FDA in March approved its first generic biologic drug—a product from a living organism.

FDA Testing And Oversight

The agency has fielded criticism about its lack of testing of generics and quality-control problems among manufacturers in India. Bloomberg News disclosed last year that the FDA had launched a $20 million program to increase testing of generic drugs—10 times the amount of money it previously had available. That program came after the agency cited quality-control problems, fraud and manufacturing violations at facilities in India, where about 40 percent of America’s generic and over-the-counter drugs are manufactured.

The U.S. Department of Health and Human Services Office of Inspector General recently released a 2015 “work plan” that includes a planned review of how often the FDA inspects generic drug manufacturers and the enforcement actions taken when deficiencies are found.

Despite the concerns about adequate oversight, FDA officials and some consumer advocates say Americans should feel safe using generic drugs and confident about their effectiveness.

“The FDA goes to great lengths to ensure that the brand and generic drugs perform as expected,” said FDA spokeswoman Sandy Walsh. All generic drugs approved by the agency “have the same high quality, strength, purity and stability as brand-name drugs.” Manufacturing, packaging and testing sites for generic drugs must pass the same quality standards as those for brand-name drugs, she said.

According to the FDA, a generic drug is identical—or bioequivalent—to a brand-name drug “in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

Dr. Michael Carome, director of the nonprofit Public Citizen’s Health Research Group, said the FDA’s standards and process for approving generic drugs “are appropriate for ensuring their safety and effectiveness.” He said consumers should ask for generic drugs because they are cheaper than brand-name products.

According to the Congressional Budget Office, generic drugs save consumers an estimated $8 billion to $10 billion annually at retail pharmacies.

“If you look at drug recalls for various quality problems,” Carome said, “the number of recalls for brand-name drugs occurs at a similar, if not greater rate, compared to generic drugs.”

Generic vs. Brand-Name Drugs

“Switching to an approved generic has resulted in severe problems for some patients,” and the risks of switching between different generics are not well understood, Mason said. “In principle, it is quite possible for two generic drugs to be equivalent to the innovator, but not to each other.”

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R. Preston Mason of Brigham and Women’s Hospital, Boston.

Substituting generic drugs for brand-name products “is of great concern to health care providers, principally because the development of generic products no longer requires extensive trials in patients,” Mason said. Bioequivalency standards “only require the generic drug to show bioequivalence with the brand-name drug in normal and healthy subjects, and not in the target patient population.”

Joe Graedon, who provides consumer information on The People’s Pharmacy website, said he was an “enthusiastic” booster of generic drugs for more than 25 years, until he received many complaints from patients. He criticizes the FDA for not sharing with doctors, pharmacists and patients the bioequivalence data that generic drug makers are required to show to prove their products are absorbed into the blood stream at the same rate as the original brand-name medicines.

Last November, the agency expressed its concern about the bioequivalence of two approved generic versions of Concerta manufactured by Kudco Ireland and Mallinckrodt Pharmaceuticals. The Kudco name is no longer used by Kremers Urban Pharmaceuticals, which now manufactures one of the generics.

On June 8, UCB, the Belgium-based parent company of Kremers Urban, announced that Kremers Urban has submitted to the FDA final results of new bioequivalence studies and requested a meeting with the agency. Kremers Urban “plans to continue making its product available to patients,” UCB said.

Mallinckrodt spokeswoman Rhonda Sciarra said the company’s generic products “are safe and effective” and “have consistently met all quality specifications and the regulatory requirements originally defined by the FDA.” Mallinckrodt “has continued to engage with the FDA regarding a scientific evaluation of these issues,” Sciarra said.

Problems with the generic versions of Wellbutrin and Toprol XL also have been reported.

In 2013, the FDA announced that a generic version of Wellbutrin XL 300 mg, a popular antidepressant manufactured by GlaxoSmithKline, had been found not to be bioequivalent to the drug and would be pulled off the market. Walsh said some versions of the 300 mg strength were not initially tested in healthy volunteers due to the possible risk of seizures.

The FDA’s Walsh said the agency’s approach to the generic Wellbutrin issue was overly cautious.

Ohio-based cardiologist Dr. Harry Lever, who works at the Cleveland Clinic, brought concerns about the generic version of the heart drug Toprol XL to the FDA in 2012. Last year, two large Indian manufacturers announced recalls of the drug. The FDA also banned imports from a generics manufacturer in India, Ranbaxy Laboratories, in the past few years.

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Joe Graedon of the People’s Pharmacy.

Lever and Graedon say the FDA doesn’t have adequate resources and enough inspectors to oversee generic drug manufacturers abroad, particularly in India and China.

Dr. Aaron Kesselheim, associate professor of medicine at Harvard Medical School, said the FDA “needs more resources to oversee drugs made overseas in India and elsewhere.” He adds, however, that there is no evidence that drugs made in India “are poor quality or unsafe across the board, or any evidence of subpar quality generic drugs being available to any measurable extent in the U.S.”

FDA spokesman Chris Kelly said there are 526 drug-manufacturing facilities registered with the FDA in India, and 10 FDA drug investigators there. In China, there are 517 facilities registered with the FDA. The agency had three drug inspectors there in November and plans to increase the number to 13, Kelly said.

The FDA also sends U.S.-based staff and inspectors on short-term trips “to ensure the safety of FDA-regulated products,” he said.

Dinesh Thakur, a former Ranbaxy director and whistleblower who reported the company’s falsification of data, said the 2012 Food and Drug Administration Safety and Innovation Act has given the FDA “additional tools and resources to more closely monitor the production processes” at foreign facilities. The act expanded the FDA’s authority to ensure the safety, effectiveness and quality of imported drugs.

“The question now is how—and whether—these facilities will address these lapses, fix their problems and produce good-quality products,” Thakur said. “I am not so sure that they have the intent and the capability to do so.”