“I’m being told that there are potentially 10 to 15 states that could see similar legislation introduced in the next year or two,” said Robert Marriott, director of regulatory affairs at the American Herbal Products Association. “Some in the industry have described this as a category killer.”
Marriott was part of a panel discussion titled "The Regulatory Landscape: Clouds on the Horizon or a Bright New Dawn?" in which speakers portrayed the legislation as both ambiguous and exacting.
Regarding the rigor of the legislation, Marriott noted that most online retailers need to perform an age verification check at the point of sale for certain products sold to minors, and some states are considering age verification at the point of delivery for specific supplements.
The scope of impact may also include products that merely mention "metabolism" on the label, including, for example, a coconut oil from The Vitamin Shoppe, said Michael DiMaggio, chief legal officer and general counsel for Nutrabolt.
"That means that no one under the age of 18 can buy coconut oil from The Vitamin Shoppe without being able to show their identification upon receipt," DiMaggio said. "This is going to be incredibly difficult. Now, will the cost of shipping go up? Absolutely."
He added that Nutrabolt, Walmart, Sam’s Club, GNC and the The Vitamin Shoppe have organized a working group to address these concerns and that this group has reached out to Amazon.
Once the New York bill is passed, the age restriction also means more class actions as lawyers will test out if IDs are checked upon supplement delivery, DiMaggio said.
"This is something that we need to really address aggressively," he added. "We're running out of options. There's already been one lawsuit filed, and I expect lawsuits may be the only way to turn this legislation out. We absolutely have to do everything possible to oppose what's being proposed in the other states."
When it comes to ambiguity, each state may legislate weight loss and muscle building supplements from various vantage points, and currently the industry doesn’t have "details on how [policy] will work differently in each of these states," Marriott said.
Experts agreed states will look to the New York legislation, which goes into effect April 22, for guidance.
"I just don't understand it," said Dr. Rob Wildman, head coach at TYM Athletic Performance. "Even digging in and going through the information, the research, the guidelines of different pediatric organizations…there is nothing in there that says keep kids away from these types of products. There is no cause-and-effect research that would say that this is a problem. Furthermore, there is no research that says that once you remove these types of products [eating disorder] problems go away."
FDA oversight
The panelists said the Food and Drug Administration offered recent hope against a backdrop of state policies.
Eva Hurt, vice president, North America of scientific and regulatory affairs at Coca Cola said her company is looking to have the right partners in the FDA when legislation is being drafted.
"The flip side of the state legislation is obviously robust, reasonable, enforceable, workable FDA legislation," she said.
Regarding the FDA reorganization, announced last year, the experts said it was promising in terms of consistency of inspections, but Marriott noted that it does not necessarily resolve the overarching question about resources.
“We'd like to see more active enforcement of [gas station] products so that they stop being used by groups like STRIPED [Strategic Training Initiative for the Prevention of Eating Disorders] to give us a bad name,” he said.
FTC
In April 2023, the FTC issued a notice of penalty offenses concerning substantiation of product claims against 670 companies. Both Nutrabolt and Coca-Cola were included on this list. It is important to note that none of the companies were accused of any wrongdoing.
"What they are really telling the group of companies is, 'We're going to watch and see if they do anything that we might consider a violation so that we can test out our theory that this letter was adequate notice,'” DiMaggio said. "We're on the list as the test case for no reason other than what I'm told by an anonymous source may have to do with success in sales. That was it."
DiMaggio added that he can't imagine that this FTC action will be successful, but "ultimately we're going to have to litigate it."
