The Vitamin Shoppe general counsel criticizes NY age-restriction law

In April of this year, New York will become the first state in the country to prohibit the sale of some dietary supplements to anyone who is under 18 years old. At least four other states are considering similar legislation.

The negative effects of this legislation for consumers and for the dietary supplements industry will be massive. Unfortunately, many legislators, regulators, consumers and even industry insiders have underestimated the impacts of this new law — and now time is running out.

Very soon in New York it will be unlawful to sell a dietary supplement for “weight loss or muscle building” to anyone under 18. The driving theory behind this unprecedented restriction is that teenagers who consume products for weight loss or muscle building are more likely than those who do not ingest these products to develop disordered eating patterns.

To be clear, there is no solid science to support this theory. It is little more than a politically expedient hunch by legislators looking to win re-election by shouting the modern-day equivalent of, “Think of the children!” In fact, a recent review of the scientific literature concluded “[t]he evidence to date does not support a causative role for dietary supplements in eating disorders.”

The reasons to oppose this legislation are myriad. Most obviously, there is no compelling justification that it will protect consumers. To the contrary, the legislation may harm them by restricting access to highly sought-after health and wellness products.

Related:NPA, New York AG spar over ‘standing’ issue in lawsuit

This law reduces the dietary supplement industry to a vice industry, on par with alcohol and tobacco. Millions of consumers would find that to be a highly inaccurate and distorted view of the products they rely on for their health and wellness goals.

Perhaps most importantly, the practical flaws of this legislation make it untenable. For example, what is a “dietary supplement for weight loss or muscle building?” I honestly don’t know, and I have been a dietary supplement lawyer for a decade. What’s more, I have sat in multiple meetings with my peers from other leading supplement and retail companies and they don’t know either.

The reason why some of the most experienced dietary supplement lawyers and regulatory experts don’t know is because New York did not bother to tell us. Instead, the new statute only hints at what products are covered.

In spectacularly circular fashion, it says a product is a “dietary supplement for weight loss or muscle building” if it is marketed for weight loss or muscle building. Thanks for that, New York. Super helpful.

Related:NY AG plans to ask for dismissal of Natural Products Association lawsuit

Beyond this, there is a list of four factors (and eight sub-factors) that a court hearing an enforcement action must consider when deciding if a particular product is restricted under the law. But the law does not explain the relative importance of each factor, nor how many factors must be present to tip a product over the line. It does not even claim to list all the possible relevant factors. Indeed, it explicitly says a court may come up with its own additional factors.

Now imagine you are in my seat. You are staring at a spreadsheet filled with thousands of products and are tasked with the responsibility of deciding which of them is a “dietary supplement for weight loss or muscle building.” You are making educated guesses, at best, which is the same thing your colleagues at other companies are doing. Since we are all guessing, there is bound to be inconsistency.

A concrete example is helpful to demonstrate that I am not exaggerating the absurdity of this legislation. One of the factors listed in the statute is whether the product label makes or implies any kind of claim to modify or maintain overall metabolism or the process by which nutrients are metabolized.

Take a jar of coconut oil. Yes, this is the same stuff available at a grocery store to cook with. Sometimes, when coconut oil is sold as a dietary supplement, its label indicates it can support a healthy metabolism. This is a perfectly acceptable structure/function claim under the Dietary Supplement Health and Education Act of 1994 (DSHEA), but it is problematic under New York’s new age restriction statute.

Does this mean it will now be illegal to sell coconut oil to anyone under 18? Does it make a difference whether the coconut oil in question is being sold at a grocery store or a supplement store? If one brand of coconut oil has the word “metabolism” on the label and another does not, but the products inside the jars are identical, is the former restricted while the latter is not?

Protein is another good example. New York’s version of the legislation says that protein powders and drinks are exempt from the restriction unless they contain other ingredients that, on their own, would be restricted. I support this exemption to a law that is otherwise severely flawed.

Nevertheless, it’s illogical and inconsistent that the most potent and popular of all ingredients for “muscle building”— namely protein— is the only one that is explicitly excluded from a law that is supposedly designed to protect minors from muscle-building products.

This conspicuous carve-out is glaring evidence of the weak and faulty logic behind this bill. And what about amino acids, the building blocks of protein? If a product claims to support muscle mass and it contains amino acids, but no other ingredients for weight loss or muscle building, is it restricted? If that product was a complete protein, it would be exempt regardless of its claims. But because individual amino acids do not form a complete protein, are they subject to the age restriction in New York?

Come April, New Yorkers are going to walk into a confused mess when they visit their preferred supplement shops and grocery stores. Additionally, whether they are 17 or 75, all consumers will pay more and be massively inconvenienced if they try to order products online to their homes.

That’s because the law also requires that every shipment of restricted product be subject to an ID check at the consumer’s home at the time of delivery. This means all consumers will have to be home to accept deliveries, which is a tremendous burden and frustration for even non-minor consumers.

The significant confusion, expense and inconvenience to both consumers and businesses because of this misconceived and poorly implemented law will only get worse if other states pass their own versions of this legislation.

Nearly 30 years ago, Congress enacted DSHEA, which grants exclusive regulatory authority over dietary supplements to the U.S. Food and Drug Administration to prevent states from regulating the commodity and enacting the kind of law about to take effect in New York. So, how did we get here?

Many states have decided to take matters into their own hands because they believe FDA is not doing enough to regulate the industry. These states are not wrong.

FDA should do a lot more to police bad actors in the industry who endanger the public by selling products that masquerade as dietary supplements but are filled with undisclosed doses of prescription pharmaceuticals. Additionally, eating disorders that afflict minors are a genuine issue that require attention and action. However, this law is not an effective or rational approach to this societal problem.

The solution is not to have 50 states with 50 different (and sometimes conflicting) regulatory schemes overseeing the industry. That would make it impossible for companies to operate and for consumers to access the products they want and deserve to support their health and wellness goals.

This industry needs to push back hard against these age restriction laws. They represent the start of a slippery slope that, if left unchecked, will undermine exclusive federal regulation and lead us into an era of chaos that threatens to make our businesses unviable.

The Natural Products Association, where I serve on the board of directors as a representative of The Vitamin Shoppe, is the only trade association that fully appreciates this risk. NPA sued New York’s attorney general in federal court in an effort to stop this law from taking effect.

NPA’s lawsuit gives the industry an opportunity to make the case that this law — and all the similar bills waiting in the wings — is unconstitutional for many reasons, including because it defies DSHEA’s mandate that the federal government, and only the federal government, must regulate dietary supplements.

Given the huge stakes, I am surprised by the level of apathy and inaction across the industry. A few companies are fully engaged in this fight, but most are sitting back and doing nothing.

Time is running out. The office of New York Attorney General Letitia James is preparing to make a motion asking the court to dismiss the lawsuit. If the motion succeeds, we will have lost our best hope of holding off an existential threat to our industry in New York and we will almost surely see other states emboldened to advance their own legislation. 

The most effective action anybody in the dietary supplements industry can take right now is to join NPA and support its efforts to stop this legislation in statehouses across the country.