FDA Lacks Ability to Effectively Safeguard Public From Risky Supplements

The Food and Drug Administration cautioned consumers in January to avoid a product called GoLean Detox. The agency’s laboratory analysis showed that the product contained ingredients from two potentially dangerous drugs, even though it was advertised as an all-natural herbal supplement to help with weight loss.  

Despite the warning, the company continues to regularly post on its social media accounts that GoLean Detox is “100% natural and organic.” Its website even calls GoLean the “perfect choice” for nursing mothers. 

Although FDA has oversight of supplements, the GoLean case shows that the agency may not be able to sufficiently protect consumers from harm caused by products that have been illegally laced with drugs. This situation is not unique: According to a recent study, after FDA found prohibited stimulants in a number of supplements on the market, sent warning letters to the manufacturers, and issued public health notices, several brands continued to use the banned ingredients.

These problems stem in part from the agency’s lack of basic information about all supplements on the market and its lack of authority, according to its current interpretation of federal law, to order recalls of drug-tainted supplement products. Safety issues linked to undeclared ingredients occur across a range of supplements but are most common in those marketed for weight loss, sexual enhancement, or athletic performance.

Weight loss

Weight loss supplements, which have sales of over $2 billion per year, sometimes contain ingredients that act as stimulants, appetite suppressants, diuretics, laxatives, or antidepressants. Adverse events associated with adulterated weight loss supplements include cardiac symptoms (such as palpitations, chest pain, or elevated heart rate), nausea, vomiting, seizures, and death.

In the case of GoLean Detox, FDA found two drug ingredients that could cause harm: sibutramine, which was removed from the U.S. market in 2010 after being linked to heart problems, and phenolphthalein, which has never been approved in the U.S. and has been linked to an increased risk of cancer.

Sexual enhancement

Since March 2015, FDA has issued warnings about 195 dietary supplements marketed for sexual enhancement that contain “varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients.” For example, the agency warned about a supplement marketed under the brand name Rhino, following reports that users experienced symptoms such as severe headaches, chest pains, complications that required surgical intervention, and dangerous drops in blood pressure.

Sexual enhancement (or “male performance”) supplements are linked to an estimated 500 or more emergency room visits annually. These products have been found to contain undeclared drugs, such as the active ingredients in Viagra (sildenafil) and Cialis (thiosildenafil), and sometimes in higher doses than in those prescription products.

In 2017, a 55-year-old man died after experiencing seizures caused by supplements for erectile dysfunction, including some that contained sildenafil and a related chemical. In some instances, men who cannot use Viagra or Cialis, because doing so could lead to harmful interactions with other regular medications, turn to supplements without realizing that they contain ingredients they should avoid.

Athletic performance

Sales of sports nutrition products reached an estimated $6 billion in 2017, and athletic performance supplements are popular with athletes and members of the military. Common ingredients include amino acids, protein, creatine, and caffeine, but some products contain hazardous ingredients that are not reflected on product labeling and are not lawfully marketed as dietary ingredients. These include steroids, steroid analogues, and an amphetamine derivative called DMAA, which is associated with increased blood pressure and heart attacks.

FDA has warned of the dangers associated with athletic performance supplements, noting that they have been linked to life-threatening reactions, including liver toxicity, and increased risk of heart attack and stroke.

FDA limited by incomplete knowledge, gaps in authority

The agency’s capacity to protect consumers from unsafe products is limited by its incomplete knowledge of what supplement products are on the market and their specific ingredients. This problem could be solved by requiring manufacturers to submit information—such as product names, ingredients, and labels—for every supplement they sell. If FDA had this information, it could quickly identify problems that arise with a product or an ingredient and act to protect consumers from similar products.   

In addition, although FDA has the authority to require a recall of most dietary supplement products, it does not have that authority for most drug products. Drug recalls are voluntary: FDA can request but not require that a company conduct one. The agency’s current policy is that since it cannot mandate a drug recall, it cannot mandate a recall of a supplement that contains a drug ingredient. This interpretation, however, undermines consumer health and safety and should be changed, by legislation if necessary.   

Sandra Eskin directs The Pew Charitable Trusts’ safe food project.