An ‘utterly unregulated Wild West’: FDA needs more oversight of dietary supplements
Boston University sophomore Stanley Huang started taking weight loss supplements in high school when he joined the cross country and track teams. He substituted supplements for meals. Huang said in an interview that he lost weight but also muscle and became so tired he regularly fell asleep at school.
New York’s ban on the sale of weight loss and muscle building supplements to minors, which Huang advocated for, is scheduled to go into effect in late April. Similar legislation is under consideration in Massachusetts. The California Legislature passed a similar ban in 2022, but the state’s governor, Gavin Newsom, vetoed it.
These bills stem from a national campaign led by STRIPED, The Strategic Training Initiative for the Prevention of Eating Disorders, based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital. The initiative reflects serious concerns among public health experts about the safety and efficacy of dietary supplements, which can include everything from multivitamins to supposed sexual enhancement elixirs.
Dr. Greg Hagan, past president of the Massachusetts chapter of the American Academy of Pediatrics, called the industry an “utterly unregulated Wild West market” of products that “range from useless to harmful.”
However, well-intentioned state bans on the sale of weight loss and muscle building supplements to minors are being stymied by litigation from the dietary supplement industry and the lack of a clear consensus about what products should be age restricted. A better solution would be for Congress to reform the outdated regulations governing all dietary supplements so the Food and Drug Administration can do a better job ensuring supplements are safe for all consumers, whether they are children or adults, and removing products from the market when problems arise.
How did we get here? In 1994, Congress passed a law governing supplements differently from food or medicine. The FDA does not approve supplements before they are sold unless they contain an ingredient not already in food and does not evaluate their efficacy. The agency can ensure that labeling is truthful and products are not adulterated and can investigate reports of serious side effects.
Some supplements are valuable health aids, like iron pills for someone with anemia. But supplements are not harmless. An estimated 23,000 Americans visit emergency departments annually due to adverse effects from dietary supplements, according to a 2015 New England Journal of Medicine report. There is evidence that young women who use diet pills are more likely to be diagnosed with an eating disorder, although it is not clear if supplement use causes or is a symptom of eating disorders.
The efficacy of supplements that make generalized health-related claims is questionable. The American Academy of Pediatrics cautions young athletes against using weight gain or protein supplements, citing the potential for “problems with safety, contamination, and quality,” while a commentary in the AMA Journal of Ethics says doctors cannot ethically recommend weight loss supplements because “these products’ safety and efficacy are unknown, ingredient lists might not be complete, and advertising could be misleading.”
The biggest safety problem is that supplements are frequently adulterated. They might include prescription medication, unapproved drugs, or drugs that were withdrawn from the market.
Between 2007 and 2016, the FDA identified 776 adulterated dietary supplements, mostly intended for sexual performance, weight loss, or muscle building. The FDA in 2021 published a list of 72 weight loss supplements tainted with prescription drugs and chemicals. Several contained sibutramine, a drug withdrawn from the US market because it increased risks of heart attack and stroke. In November 2023, the FDA warned consumers against using products with the unapproved drug tianeptine, also known as “gas station heroin,” which was being marketed as a mood-enhancement supplement but caused seizures and loss of consciousness.
When the FDA identifies tainted products, it usually relies on companies to voluntarily recall them. A 2018 report by Dr. Pieter Cohen, a Cambridge Health Alliance internist, found that about half the supplements the FDA considered tainted remained on the market, and the FDA almost never used mandatory product recalls. A paper Cohen published in 2021 found that after the FDA warned dietary supplement companies against using phenibut — a drug approved in Russia but not the United States due to risks of coma and death — three of the four supplement products that advertised as including the drug had increased drug quantity.
Labels can also be inaccurate. Cohen tested generic drugs and dietary supplements containing the active ingredient galantamine, used in drugs to treat dementia and marketed in supplements to improve memory. All the drugs contained an amount of galantamine within 5 percent of the amount listed on the label. The supplements contained between 2 percent and 110 percent of the labeled quantity.
Supplement company representatives say these problems primarily reflect bad actors who sell unreliable products online. Some manufacturers have products certified by third-party verifiers to ensure manufacturing processes and labeling adhere to professional standards.
The best way to eliminate bad actors and ensure all companies offer safe products is by strengthening federal law. Senators Dick Durbin and Mike Braun introduced a bill in 2022, a version of which is expected to be reintroduced this year, that would require supplement producers to list their products in a new public FDA database with an ingredient list, copy of the label, and any health claims. This bill, supported by industry trade group the Council for Responsible Nutrition and the American Medical Association, is a good start.
It should be paired with additional steps to give the FDA greater oversight authority. This probably means expanding the FDA’s oversight budget and clarifying its authority to impose mandatory recalls and fines when a supplement contains an unauthorized ingredient or is inaccurately labeled. (Today, the agency’s authority is unclear when a supplement is tainted with a prescription drug.) It means giving the FDA authority to review and act on information submitted to the database — for example, to forbid the sale of a product containing a dangerous ingredient like phenibut or tianeptine before sales begin. Congress could also consider requiring supplement companies to use a thirdparty verifier or tightening standards around when an ingredient counts as a “new dietary ingredient” that requires FDA approval.
A Massachusetts law requiring adult involvement before a teen buys a weight loss or muscle building supplement would be a reasonable policy. But to truly protect public safety, the federal government must close any loopholes that have allowed dangerous products to reach and remain on the market.