Massachusetts legislation to limit consumer access to weight loss and bodybuilding supplements vaguely defines the products and unfairly links them to eating disorders, but still could open the door on restrictions in other states, say industry trade groups.

“The most troubling concern is that we are looking at legitimate, legal products – by every federal definition allowed to be marketed – that on the state level are being imputed [as dangerous] because of another concern that may or may not be related,” said Council for Responsible Nutrition executive Mike Greene.

The bill, H. 3471, would ban sales to minors of weight loss and bodybuilding supplements and would require retailers to sell the products from behind the counter and post conspicuous warnings about potential adverse effects.

The bill says the affected products “may include, but are not limited to, thermogens, which are substances that produce heat in the body and promote more calorie burning, lipotropics, which are compounds that help break down fat during body metabolism, hormones, including hormone modulators and hormone mimetics, appetite suppressants, diuretics and laxatives.”

Additionally, H. 3471 would require retailers to “conspicuously post at each purchase counter a notice … clearly communicating that certain dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment, tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury and death.”

It would require that “no dietary supplements for weight loss or muscle building shall be sold to any person under 18” and that retailers store the products “such that the dietary supplements may only be accessed by a manager, assistant manager, acting manager or other supervisory personnel.”

In a pharmacy, the products “shall be placed behind the pharmacy counter” and purchased upon a request to a manager or other pharmacy staff. However, the bill does not include any language stating that pharmacy employees or other retail store staff can refuse to sell weight loss and bodybuilding supplements to adult consumers.

Retailers would be fined at least $100 for the first violation, $200 for a second and $300 for a third or subsequent one, according to the legislation.

Vague Details Equal Bad Policy – Industry

Greene, CRN’s government relations vice president, refutes the contention that supplements are under-regulated and says the Massachusetts legislation does not solve the problem it targets because of its scope.

“If there are adulterated or misbranded products on the market, FDA and the states have the authority to remove [those] products from the market. Adulterated or misbranded products marketed by bad actors have no place on the market at all,” Greene said in an interview.

He added the legislation would impact only products sold in stores. “It would not stop individuals from purchasing egregious products on the internet or crossing state lines to buy the same products in adjacent states.”

In addition to not tackling the problem of adulterated products sold online, the legislation would draw unintended supplements into the mix because it loosely defines weight loss and bodybuilding products, Greene said.

“These two definitions … don’t exist in federal or state statutes, so there is great concern over what products would be restricted to minors.”

Daniel Fabricant, Natural Products Association executive director and CEO, makes a similar argument, saying the legislation is “very scary.”

“We have no definition in the proposed [legislation] that makes it clear what is in and what is out. With any legislation the devil is in the details – those without the details aren’t good policy,” Fabricant said.

Preventing Massachusetts or other states from setting age restrictions or requiring behind-the-counter sales of supplements likely could not be accomplished by arguing in litigation that federal regulations pre-empt those state laws.

FDA is authorized to regulate the manufacturing, labeling and marketing of nutritional supplements and state initiatives to impose more stringent regulation would prompt litigation arguing federal pre-emption. However, FDA’s authority does not trump state laws that would restrict sales of the products.

A Test For Industry

On the legislation’s chances, Greene said “we are taking it very seriously.” He suggested the industry prioritize lobbying against H. 3471 before similar proposals take hold elsewhere.

“I haven’t heard of any new bills popping up in other states, but … the states are a laboratory for new policy. If we don’t stop this legislation here, we will most certainly see it introduced in other states.”

Greene pointed out the bill also introduces weight loss products as a potential concern related to teen health.

“Everything we’ve seen with age restrictions has been associated with performance enhancement, like bodybuilding. To some degree, I’ve never seen it focus on weight loss supplements,” he said.

He suggested education is the key to safe use of weight loss and bodybuilding products and if there is a place for it, CRN would contribute to helping educate young people.

“But we don’t believe you need to restrict a category of products,” Greene said, adding that banning sales to minors and moving products behind the counter could push retailers to stop selling the products – and possibly other types of supplements.

Greene argued against the bill during a Sept. 17 hearing of the Massachusetts legislature’s Joint Committee on Public Health as doctors, eating disorder advocacy groups and consumers spoke in favor. The bill’s author, Rep. Kay Khan, a Democrat from the Newton area and a psychiatric care nurse, also spoke during the hearing.

The committee is reviewing stakeholder input before providing its opinion on the bill; a date for a legislative vote has not been publicized. The act would take effect 180 days after passing.

CRN retained counsel in Massachusetts, plans to continue lobbying efforts in Boston and to “work with committee members to provide more information and be more visible,” Greene added.

Advocacy Groups Push For Action

The bill has support from the National Eating Disorders Association, which looks at the bill as a trendsetter for other states.

“Our hope is that Massachusetts will lead the way in addressing this crucial public health issue. We hope that with success of this legislation in Massachusetts we will be able to bring it to other states as well,” said Kerry Dolan, a program manager for NEDA.

Dolan said diet and bodybuilding products can be catalysts for eating disorders by encouraging consumers to reach an “ideal” body standard.

She added that research shows between 35% and 57% of adolescent girls engage in “crash dieting, fasting, self-induced vomiting or abusing diet pills and laxatives” and 30 million US consumers suffer from eating disorders at some point.

Many quick-fix diet and bodybuilding products are available because the market is “under-regulated,” Dolan said.

“These products are not pre-screened by the FDA before becoming available to consumers. Worse yet, these products are widely advertised across mainstream media,” she said, adding “greater regulation of these products is needed across the industry as a whole.”

As examples, she noted that TV talk show host and physician Mehmet Oz drew the ire of regulators for promoting bad science and bogus health advice about weight loss supplements. Oz was grilled during a 2014 Senate hearing about the claims ([A#05140623002]).

Research Recommends State Role

Research published in the Journal of Public Health Management Practice in 2014 recommended that states regulate sales of supplements due to concerns about teens’ use of supplements. The study stated a “substantial portion” of supplements are marketed for weight loss or bodybuilding, though products are not recommended by physicians and “most are not effective to accomplish the promised results” Also see "State Enforcement Needed On Weight Loss, Bodybuilding Supplements – Study" - Pink Sheet, 25 September, 2014.

“Many dietary supplements sold in stores can give false hope to those struggling with eating disorders about ‘miracle’ weight loss, causing some individuals to aim for unreachable expectations, which can be extremely dangerous to their health,” said the researchers led by Jennifer Pomeranz of Temple University’s Department of Public Health, Center for Obesity Research and Education.

They argued that the Dietary Supplement Health and Education Act created a “reactionary, rather than preventive, framework, rendering the FDA’s regulatory control too weak to adequately protect consumers” from the products.

“The lax federal regulatory scheme for dietary supplements leaves extreme gaps in federal oversight that should be filled by state governments,” the researchers said. “States should use core public health policy strategies to protect consumers and especially young people from ineffective, mislabeled and potentially dangerous products marketed for weight control and muscle building.”

Massachusetts Bill Raises Specter Of States Restricting Supplement Sales

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