The top regulatory considerations for sports nutrition companies
“The sports nutrition category has typically been the 'red-headed stepchild’ of the dietary supplement industry,” Collins, a partner and co-founder of law firm Collins Gann McCloskey & Barry told an audience at the inaugural NutraIngredients-USA Sports Nutrition Summit in San Diego last week.
That characterization comes from the category’s history, he explained. “There’s a certain percentage of people, particularly men, who want to be jacked,” said Collins, who also serves as Legal Counsel to the International Society of Sports Nutrition (ISSN).
Before the ‘healthy active lifestyle’ trend of everyday increased protein intake, or the continual blurring of the line between a typical snack and beverage versus performance enhancing nutrition, sports nutrition products catered mostly to bodybuilders—the percentage of people who aspire to look like Arnold Schwarzenegger.
To cater to an audience that want to achieve that look, it wasn’t uncommon for anabolic steroids, a drug, to make its way into dietary supplements.
Because of the category’s history, nature and audience, the regulatory scrutiny it receives is distinct from the rest of the dietary supplements industry. Here are some of the highlights from Collins’ presentation at the Summit:
Stay abreast of the laws, even those of other states
Every now and then, state governments may propose or even pass a law targeting the sports nutrition category, creating a jigsaw puzzle of laws that companies have to navigate.
Examples of laws that have been enacted include California’s Prop 65, which means, depending on formulation, some brands need to put a Prop 65 warning on their labeling to be compliant for commerce in California.
Other examples included a proposal struck down more than once in Massachusetts to restrict sale of weight loss and muscle supplements to behind the cashier counter, discouraging sales to adolescents, as well as an Arizona pharmacy board plan to regulate supplements in the state like OTC drugs.
“Even if you’re not based in these states, laws like these could affect your company,” Collins said. His tip? Keep an in-house counsel, or at least stay abreast of the law.
CBD ingredients in sports nutrition, not a good idea right now
Cannabidiol, or CBD for short, is currently the darling of the consumer packaged goods industry.
Stakeholders in the CBD industry are so optimistic that the compound will become obtain full legality that, even though the FDA has unequivocally said it is not a legal food and beverage ingredient, product development in the space continues anyway, and retailers large and small are stocking walls of shelves with products containing the ingredient.
“The reality is the genie is so far out of the bottle that it’s hard to put it back in,” Collins said. “It is so abundant throughout the US at this point that it would be hard for FDA to go after everyone making it. It’s still illegal, so it’s more of an enforcement issue.”
CBD is often discussed as an anti-inflammatory, so in a sports nutrition context, formulators are interested in exploring the ingredient for recovery products, Collins explained.
But there are ramifications specific to sports nutrition product buyers. THC, the compound in the marijuana family of plants that give the psychoactive high, is still banned in sports by associations like WADA.
“What if an athlete takes 10 servings of this CBD supplement, causing a drug-tested athlete to test positive?” Collins asked.
“So I would suggest that CBD in a sports nutrition product has a high level of other risks compared to other products.”
Shady ingredients, a game of whack-a-mole
Because of the lack of a pre-market notification requirement in the supplements space, the industry has seen ingredients come and go after the regulators and lawmakers scrutinize a certain substance.
For example, in the 1990s, synthetic pro-hormones were more rampant in the sports nutrition space. Because they were synthetic, Collins explained, “and they certainly didn’t exist in the food supply chain,” they weren’t DSHEA compliant, and thus, illegal.
After various attempts to suppress the sale of these prohormones, the Designer Anabolic Steroid Control Act passed in 2014, killing the supply chain. “But just because the supply is dead, it doesn’t mean demand goes away,” Collins said.
What comes next is a cycle that he described as a game of whack-a-mole. With a diminished supply of these steroids, Selective Androgen Receptor Modulators (or SARMS) sprang up in the last few years. (Read more about the industry effort to curb SARMS HERE).
Similarly, when Ephedra, a fat burner, went out of the picture, DMAAs came in. “When one thing goes down, something comes up,” he said.