Four takeaways from N.J. hearing on bill targeting dietary supplements

On Sept. 23, the Assembly Health Committee of the New Jersey Legislature voted 6 to 2 (with one abstention) to pass A1848.

The bill prohibits the sale to minors of diet pills and dietary supplements for weight loss or muscle building, unless the minor is accompanied by a guardian or parent.

A1848 imposes a civil penalty of up to $750 for violating its provisions, and in order to complete delivery of a diet pill or dietary supplement for weight loss or muscle building, a person must obtain the signature of an adult who lives in the home. A1848 does not apply to products prescribed by a licensed health care professional.

Welcome to the new normal: Year after year, states across the country are fervently introducing legislation to restrict to minors the sale of dietary supplements marketed for weight loss and muscle building. Industry trade groups representing manufacturers and retailers of dietary supplements warn the consequences of passage of these bills could be calamitous for business and consumer access to a wide range of beneficial, safe products already subject to comprehensive federal regulations.

Below are my four takeaways after listening to a recording of the New Jersey Assembly Health Committee hearing on A1848.

1. The sponsor of A1848 and one of the bill’s chief opponents both stood their ground during the hearing, with neither backing down.

Since 2005, Steve Mister has been leading the Council for Responsible Nutrition (CRN). He testified during the New Jersey hearing and made a strong case for his group’s opposition to A1848.

You’ve likely heard at least some of these arguments before. Age restrictions will limit access to supplements for all consumers, not just minors. Dietary supplements aren’t the cause of eating disorders. Bills like A1848 reflect a fundamental misunderstanding concerning the federal regulation of these products. And A1848 will impose a significant burden on the state to inspect stores.

More entertaining and enlightening was Mister’s sometimes testy exchanges during the hearing with the bill’s sponsor, Assembly Health Committee Chairman Herb Conaway Jr., a Democrat who is running for Congress.

For instance, while raising concerns about the bill’s restrictions imposed on muscle building products, Mister cited products that could be captured in the bill like those intended for young kids that contain calcium and vitamin D and intended to promote bone growth and muscle.

“You have other products marketed for elderly people who are suffering from atrophy and muscle weight,” Mister continued before being interrupted by Conaway.

“Which won’t be affected by this bill and why are you raising it?” the lawmaker asked.

Mister shot back, “Because they will be sir.”

Conaway then seemed to reference the bill’s language that a parent can accompany a minor to purchase a calcium supplement or anything else. Mister countered that in New York, where age restrictions are in place for supplements for weight loss and muscle building, “the products are either being removed entirely, or they’re not being sold online areas like Walmart.com, or [retailers are] just saying, ‘We’re not going to sell these to any New York resident because we don’t want the liability of having it be delivered to a 17-year-old.’”

New York Assembly Bill A5610, Mister suggested, doesn’t just affect the products targeted by advocates of the age restrictions, it limits access for older people “because retailers will pull them off the self-service shelves or put them behind a glass door.”

To which Conaway responded, “By the way, the legislation doesn’t call for that … we’re not asking for any of these things to go behind the counters.” He added, “Let me go to the question of … this ‘access.’ I have to say I don’t buy that.”

You get the gist. Steve Mister stood his ground with the bill’s sponsor, and neither man really backed down from their respective positions.

2. The bill’s sponsor rejected the notion that combatting eating disorders is the primary motion behind the legislation.

We — the trade press — keep hearing that these age-restriction bills are being introduced by advocates seeking to address an epidemic: namely, eating disorders.

“Currently, there is no credible, scientific data that the products identified in this bill lead to or cause body dysmorphia, eating disorders or other mental health issues — none,” Mister said in his testimony. “Now let’s be clear. There’s no medical literature despite what the proponents of the bill will tell you that demonstrates a causal relationship between the use of these products and the onset or exacerbation of eating disorders.”

Industry has made the argument above again and again. Here’s the news, or curveball: Conaway responded that the focus of his bill is not “on eating disorders or body dysmorphia.”

“The focus is on use and misuse of these products, which [causes] other functional problems in the body,” the lawmaker said. “That’s the main driver of this bill. I won’t argue with you on whether or not these products are the main cause of eating disorders … but I think there is a relation there.”

3. Amendments to A1848 target the same products listed in New York law.

In discussing the potential misuse of certain supplements, Conaway raised the hypothetical of a minor seeking to use creatine to build muscle mass and who might take more than recommended to his or her detriment.

“Maybe I’ll be able to be in the starting lineup,” the lawmaker said, presumably quoting the thinking of a minor, “and now you have a problem with organ failure and organ damage related to the misuse of these products.”

“That’s the main reason why this legislation … is up for consideration today,” he continued. “I just want the members to understand it’s not just about the question of whether or not weight loss or body dysmorphia or eating disorders is at play here. It’s the other physical harms that might come to children who misuse these drugs, who use them to excess, because they’re trying to achieve what is marketed to them….”

Mister answered, “Mr. Chairman, with all due respect, if you are looking at lawfully marketed dietary supplements, you will find that they have a very wide margin of safety. Even if a child uses more creatine than is indicated on the label, I think you’d be hard-pressed to find a harm from that, and I’d be happy to show you literally dozens of studies.”

Conaway then said, “I mentioned creatine but there are other products listed in this bill where if they’re used will cause other effects. Creatine’s not the best example of the harms.”

Amendments to A1848 call out specific products as factors for a court to consider in determining whether an OTC diet pill or supplement is marketed to achieve weight loss or muscle building. Some of these products include an ingredient approved by the U.S. Food and Drug Administration for weight loss or muscle building, a steroid, creatine, green tea extract, raspberry ketone, garcinia cambogia or green coffee bean extract.

This language should look familiar since it was lifted from New York’s bill.

During the hearing, Conaway never identified the specific harms associated with the products above or the extent to which minors are abusing or misusing those products (other than the hypothetical creatine example).

Mister pointed out products causing “serious health effects” like anabolic steroids aren’t lawful dietary supplements, and he added that FDA-regulated supplements and the ingredients in them “have a wide range of safety.”

“I’m not going to argue about young people who are ordering steroids off the corner of the internet,” Mister said. “We should be doing more to keep those products from coming into the state of New Jersey. But that is not the products that are being sold at Vitamin Shoppe and GNC and CVS.”

By then, Conaway had heard enough and opened up the hearing for questions from his colleagues — and there were only a few.

4. The Dietary Supplement Health and Education Act of 1994 (DSHEA) is seemingly an afterthought for some legislators.

Mister was not the only one who testified during the hearing. Natural Products Association (NPA) Director of Government Affairs Kyle Turk highlighted the various ways in which supplements are regulated under the 30-year-old Dietary Supplement Health and Education Act of 1994 (DSHEA).

Among his observations, Turk noted FDA “has authority to safeguard the public against unsafe products” as well as the “power to remove immediately any product if it poses a health hazard.”

“The federal government has vast enforcement powers and has a long track record of punishing criminals who break the law, and we support vigorous enforcement of the law to protect consumers,” Turk concluded in his testimony, “but still the FDA, who’s the chief regulator of dietary supplements, has found no connection between the use of dietary supplements and eating disorders.”

Conaway responded, “I’ll just briefly reiterate that the bill is not targeted at eating disorders, per se.”

The brief exchange between Conaway and Turk was more newsworthy, in my estimation, thanks to a question posed by the lawmaker. He essentially asked the NPA executive whether FDA visits the manufacturing facilities of dietary supplement firms.

We know the answer, of course. Yes, FDA audits hundreds of supplement firms annually. But the question — in and of itself — highlights that lawmakers introducing bills to restrict access to dietary supplements are not always familiar with the most rudimentary of details regarding how these products are regulated.

If states wish to fill in gaps in federal oversight of dietary supplements to protect the health and safety of their citizens, I would like to believe that trade associations and others aligned with industry would engage in a productive discourse with legislators. But lawmakers should first do their homework before introducing bills like A1848. Otherwise, any legislation that fails to reflect FDA’s authorities and other safeguards in DSHEA is likely to harm business while failing to solve an actual problem.