A Texas-based nutrition company pleaded guilty to selling misbranded workout supplements.
With lax FDA regulations on supplements, it can be hard to know which products are healthy and safe.
A Texas nutrition company pleaded guilty to distributing misbranded workout supplements this January. The company, known as Defyned Brands or 5 Star Nutrition LLC, has agreed to forfeit $4.5 million and follow “certain compliance reporting requirements,” as part of their guilty plea, according to the Department of Justice (DOJ).
Specifically, Defyned Brands misbranded products Epivar, Alpha Shredded, and Laxobolic, according to the DOJ. What the products should have been branded as instead, or any health risks they may have presented, is unclear.
Workout supplements have been a source of conflicting opinions in recent years, with some fitness enthusiasts touting their benefits on exercise potential and others criticizing their use of sometimes harmful chemicals or added sugars. There are layers to each side of the argument, thickened by the ever-growing supplement industry. The pre-workout supplement market alone is projected to reach $28.58 billion by 2031.
Are low-level regulations on workout supplements elevating health risks?
Most workout supplements, and nutritional supplements in general, do not require approval from the Food and Drug Administration (FDA) before hitting the market. This can lead to inconsistencies in the integrity and quality of the group, as well as unanswered questions about an individual product’s health benefits.
Still, the FDA doesn’t ignore workout supplements altogether, either. (The regulations they do have in place are part of what has landed Defyned Brands in trouble.)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides some structure around supplement regulation. Under the FD&C Act, supplement manufacturers are responsible for ensuring that supplements meet certain requirements, including not violating any federal law, being adulterated, or being misbranded – as was the problem with the company in Texas.
Supplements that contain new dietary ingredients require more oversight and companies show the FDA info suggesting their product “will reasonably be expected to be safe” before marketing.
According to the FDA, “If a manufacturer or distributor makes a structure/function claim (a claim about effects on a structure or function of the human body), a claim of a benefit related to a classical nutrient deficiency disease, or a claim of general well-being in the labeling of a dietary supplement, the firm must have substantiation that the claim is truthful and not misleading.”
The responsibility of “substantiation” falls to the firms themselves, but the FDA has the authority to double-check and enforce rules. This can play out if they investigate adverse reports, among other scenarios.
Unfortunately, checking up on companies after problems have occurred isn’t exactly a proactive approach to a healthy lifestyle — which, for some frequent gym-goers, is a high priority.
Louise Hateley, a physiotherapist and the Director of In Stride Health Clinic in Australia, says she often talks to clients about safe supplement use in their workout routines. In these conversations, she says she encourages people to be critical when selecting a supplement and to use the product sparingly – and recommends that other doctors and sports professionals engage in similar discussions. Choosing supplements from companies that use third-party testers is also a good idea, Hateley says.
“It's important to understand that dietary supplements are subject to laxer FDA regulation than other medications and foods,” Hateley says. “It is important to advise patients to carefully read labels, to avoid falling for overly dramatic health claims, and to think about their medical problems and fitness objectives.”
She adds that everyone is different, and a supplement that may feel safe and is effective for one person could have a different impact on someone else. Further, if you or your patient are wary of supplements for the above reasons (or others), reap benefits through food instead. Hateley recommends looking for hearty sources of protein and carbs after a vigorous workout to aid in muscle repair.
What this means for you
A Texas workout supplement company pleaded guilty to distributing misbranded products. Companies that manufacture workout supplements are subject to relaxed rules and regulations, leading to inconsistencies in the market.