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Popular weight-loss and workout supplements on sale in hundreds of vitamin shops across the nation contain a chemical nearly identical to amphetamine, the powerful stimulant, and pose dangers to the health of those who take them, according to a new study. The Canadian health authorities in December called the chemical, BMPEA, “a serious health risk,” and pulled supplements that contain it from store shelves.

The Food and Drug Administration documented two years ago that nine such supplements contained the same chemical, but never made public the names of the products or the companies that made them. Neither has it recalled the products nor issued a health alert to consumers as it has done with other tainted supplements. The F.D.A. said in a statement that its review of supplements containing the stimulant “does not identify a specific safety concern at this time.”

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.

The Supplements Found to Contain BMPEA

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Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group.

“To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,” said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Dr. Fabricant disagreed, saying in an interview that having industry officials run the F.D.A.’s supplement division was “an incredible benefit to the agency.” He said that during his tenure, the division worked to get unsafe products off the market and issued a mandatory recall of a supplement involved in a deadly multistate outbreak of liver disease. “I did more there in three and a half years than was done in the 16 years prior,” he said.

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

The F.D.A. was the first to begin investigating products that turned out to contain BMPEA. As early as 2013, scientists at the agency said in an article published last year that they noticed many popular supplements listed among their ingredients a little-known plant called acacia rigidula, a shrub native to Mexico and southern Texas.

The plant’s presence in so many supplements was a red flag, said Dr. Pieter A. Cohen, the lead author of the new study published Tuesday and an assistant professor at Harvard Medical School. He said it is not uncommon for companies to spike weight-loss and exercise supplements with amphetamine-like chemicals, then hide them on their labels under the names of obscure plants to give the impression they are natural botanical extracts.

The F.D.A. tested 21 popular supplements that listed acacia rigidula on their labels and found nine of them tested positive for varying amounts of BMPEA, the agency reported last year in The Journal of Pharmaceutical and Biomedical Analysis. F.D.A. officials did not, however, name the specific products.

Although BMPEA was first synthesized in the 1930s as a replacement for amphetamine, it was never introduced as a pharmaceutical drug and its side effects were never studied in humans.

Under federal law, dietary supplements — with some exceptions — can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.

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It was only after trying unsuccessfully to find out from the F.D.A. which supplements contained BMPEA that Dr. Cohen and academics at other universities conducted their own tests, identifying the stimulant in 11 of 21 products. Their findings were published in the journal Drug Testing and Analysis.

In December, the Canadian health authorities said they forced a recall of a supplement that lists acacia rigidula as an ingredient — JetFuel Superburn — after the product was found to contain BMPEA and another amphetamine-like stimulant. The Canadian government issued a public health alert about BMPEA to consumers: “Amphetamine stimulants can increase blood pressure, heart rate and body temperature; lead to serious cardiovascular complications (including stroke) at high doses; suppress sleep and appetite, and be addictive.”

As of Tuesday morning, three of the supplements — JetFuel Superburn, JetFuel T-300 and MX-LS7 — found in Dr. Cohen’s study to contain BMPEA were for sale at Vitamin Shoppe, one of the country’s largest retailers of supplements, with hundreds of locations. None list BMPEA as an ingredient. One of the products is the same one that the Canadian health authorities pulled from stores. Vitamin Shoppe later announced that it was pulling these products and all others that list acacia rigidula on their labels.

“We are concerned by the findings outlined in the study,” the company said in a statement. “The Vitamin Shoppe decided to remove these products because the safety of these products is now in question and may not be in compliance with F.D.A. regulations. In addition, the Vitamin Shoppe continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe.”

The other supplements Dr. Cohen’s study listed as containing BMPEA were Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.

On Tuesday, one of the leading supplement industry trade groups, the Council for Responsible Nutrition, called on the F.D.A. “to enforce the law” and remove products containing BMPEA from the market “before there are serious health consequences.”

Bastiaan Venhuis, a scientist who studies tainted supplements at the National Institute for Public Health and the Environment in the Netherlands, said that the physiological effects of BMPEA are most likely very similar to those of DMAA, an amphetamine-like stimulant that can cause heart attacks and strokes.

Supplements containing DMAA were banned from military bases by the Department of Defense in 2011 after they were implicated in the deaths of two soldiers. The F.D.A. issued a health alert warning consumers about DMAA 16 months later — long after Australia, Britain, Canada and Sweden had banned it.

“I think health authorities should be concerned,” Dr. Venhuis said of BMPEA.

Dr. Cohen said the F.D.A. appeared to be waiting for evidence that BMPEA was harming consumers. “If they wait long enough,” he said, “I suspect they will have that level of evidence to remove it from the market.”

Regulation of the supplements industry has long been contentious. Under a 1994 law, supplements are exempt from the rigorous oversight applied to prescription drugs and medical devices. They do not have to undergo federal reviews of their safety or effectiveness before they are sold to the public, and as a result tainted supplements are usually pulled from the market only after consumers are harmed.

The Natural Products Association played a crucial role in the passage of that law — the Dietary Supplement Health and Education Act — which was sponsored by Senator Orrin G. Hatch, Republican of Utah, where many supplement companies are headquartered. Mr. Hatch has long been a top recipient of campaign contributions from the Natural Products Association, and his son, Scott Hatch, is a founding partner at a Washington firm that lobbies for the organization.



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In 2013 and 2014, the Natural Products Association spent nearly $1.5 million lobbying the Food and Drug Administration, members of the House and Senate, and the Federal Trade Commission, according to the nonpartisan Center for Responsive Politics. The trade association has lobbied against the Dietary Supplement Labeling Act, a bill that would require supplement labels to carry basic information about side effects and ingredients that could be harmful to children and pregnant women.

Both the F.D.A. officials with industry ties came to the agency from senior positions at the Natural Products Association. Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency’s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.

Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency “has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.”

Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had “an excellent safety record.”

“The industry itself supports and has implemented strong self-regulatory mechanisms,” she said in an industry news release at the time.

Ethicists disagree. “There are just too many other people who could have that job who don’t have these conflicts,” said Arthur L. Caplan, the head of the division of medical ethics at New York University Langone Medical Center.

Public health experts said that the agency has moved too slowly when alerted to dangerous supplements. In February 2013, Dr. Kenneth R. Spaeth, the division chief of occupational and environmental medicine at North Shore University Hospital in New York, reported to the F.D.A. that 20 of his patients developed muscle aches, fatigue and liver damage after using a brand of B vitamins. Some female patients had stopped having their periods and started growing facial hair. He said he told the F.D.A. he suspected the vitamins were contaminated with anabolic steroids.

Dr. Spaeth said he got no response for weeks and called the agency numerous times. He also sent multiple emails to Dr. Fabricant and other F.D.A. officials, pleading with them to get the vitamins off the market.

In response to a request under the Freedom of Information Act, the F.D.A. said it was “unable to locate” any records of Dr. Spaeth’s communications. Dr. Spaeth provided The New York Times with the emails.

“I am hoping you folks are taking this seriously,” Dr. Spaeth wrote to Dr. Fabricant and other F.D.A. officials in an email on April 17, 2013. “I have 20 very worried patients and I have little to offer them. Particularly about what they’ve been exposed to and the possible long term risks.”

On July 26 of that year — nearly six months after Dr. Spaeth first contacted the F.D.A. — the agency issued a public health alert warning consumers not to take the vitamins and saying it had asked the company that made them, Purity First Health Products, to recall them.

“The bottom line is that I feel the F.D.A. did not do everything they could to protect the health of my patients and anyone else taking these supplements,” Dr. Spaeth said.

Dr. Fabricant said that the agency needed time to build a case against the vitamins because it had a legal burden to prove that they were dangerous before it could seek to have them recalled.

“I understand his frustration,” Dr. Fabricant said of Dr. Spaeth. “But at the same time, I don’t think you can say anything about the agency not taking the case seriously. We acted very swiftly.”



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