“We are seeing an uptick in the number of bills that are introduced,” Mike Greene, CRN’s vice president of government relations, told NutraIngredients-USA. Greene said many of these bills had little chance of passage even at the time of their introduction but nevertheless required monitoring.
Specific age group is a new facet
Greene said the bill in question, Massachusetts House Bill (HB) 3471, was unusual in that it was targeted at specific categories and included age parameters. The bill would have required weight loss and muscle building supplements to be placed behind the pharmacy counter and be made unavailable to minors except by specific request. The age group aspect of the bill is a new facet among these sorts of bills that target the industry, Greene said.
“This bill was introduced at the end of last year. It would have restricted minors from purchasing these products. We have never believed in age restrictions,” Greene said.
The bill was introduced by Rep. Kay Khan. At the time of the bill’s introduction last fall, Khan told NutraIngredients-USA that, “I have filed a bill this legislative session that would ban the sale of weight-loss and muscle-building supplements to minors under the age of 18, as well regulate sales to the general public, by placing the products behind store counters. There are ingredients in these products that are not monitored by the FDA, and only when tragic circumstances occur does the FDA evaluate the potential harmful effects of a weight-loss product.”
Khan also said that she was swayed by the actions of Massachusetts Attorney General Maura Healey, who last year signed a letter circulated by New York Attorney General Eric Schneiderman that was sent to members of the US Congress seeking more regulation of the dietary supplements industry.
Khan is also a psychiatric nurse who has worked with patients suffering eating disorders. Khan controversially had maintained that these categories of dietary supplements exacerbate these conditions among vulnerable populations like minors. The bill was sent to a study by the Joint Committee on Public Health (JCPH) on Thursday, effectively ending any prospect for passage in this legislative session. CRN had provided testimony against the passage of the bill, Greene said.
“We did not believe her bill as written accomplished what she set out to do,” Greene said.
No data to back assertions
At the time of the bill’s introduction, CRN and other trade associations asserted that there was no evidence that these products, as a broad category, posed particular risks. And Khan’s bill cast a very wide net, including in its definition of the target category products that include thermogens, lipotropics, hormones, including hormone modulators and hormone mimetics, appetite suppressants, diuretics and laxatives. (Keen observers will note that some of these are not legal dietary ingredients for use in dietary supplements in the first place).
“We’ve never seen a bill like this introduced in any of the other states,” Greene said. “We’ve seen bills introduced that focused on individual ingredients, but not on whole categories.”
Khan’s bill would have also proposed a mandatory warning “clearly communicating that certain dietary supplements for weight loss or muscle building are known to cause (emphasis added) gastrointestinal impairment, tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death.”
“This bill would have needlessly restricted safe, legal and regulated products that may help with weight management or fitness goals. Additionally, it would have created loss of revenue to state businesses and had negative fiscal implications for retail establishments and pharmacies,” Greene said.
Greene disputed Khan’s notion that FDA does not monitor the ingredients that are used in weight loss and sports nutrition supplements. The key point, he said, is that the agency has ample authority to move against problem products and ingredients and has done so in cases like ephedra and DMAA. If the data supports action, FDA has taken it, he said.
“If there are concerns with products FDA has the authority to deal with it,” he said.