The Natural Products Association (NPA) said it will file a motion for preliminary injunction in its lawsuit against New York Attorney General Letitia James which seeks the repeal of the New York state law banning sales of “weight loss” and “muscle building” supplements to minors, according to Daniel Fabricant, PhD, president and CEO of NPA.
 
NPA first filed suit challenging the constitutionality of the law in December last year in the U.S. District Court for the Eastern District of New York. In its preliminary injunction, the association is seeking to prevent the law from going into effect ahead of its enactment date, Apr. 22.
 
Meanwhile, the Council for Responsible Nutrition (CRN), which filed a lawsuit on Mar. 14 against James seeking the same outcome (in a separate U.S. District Court in New York’s Southern District), filed a motion for a preliminary injunction against the age restriction bill on Apr. 3.
 
Fabricant: The Law, As Written, Is Too Vague to Follow  
 
In a discussion with Nutraceuticals World, Fabricant said that whether or not an injunction is granted in either lawsuit ahead of the Apr. 22 enactment date, NPA will stay the course until all of its objections and questions are answered.
 
“This is a fight that we can’t afford to lose,” he said. “I’m not necessarily going to say that I feel pessimistic or optimistic, but our attorneys have done really well in recent litigation such as what we’ve done with NAC. I think our strategy will be about how many of these questions we can get in front of the judge when we have our day in court. An injunction is important in a lot of ways, but even if we don’t get what we want with that motion, we’re not done and we still have a chance to have all of these arguments heard in a broader sense. The point of the injunction itself is to prevent this law from going into effect on the 22nd of this month, because there are so many questions, and so much that we just don’t know. Which ingredients are in, which ones are out? What exactly can you say, and what exact form of speech isn’t allowed? It’s so vague that people don’t know what to do.”
 
The injunction motion was “something we had to throw down,” Fabricant said. Beyond stalling the enactment of the law as it’s written, NPA hopes that the motion could slow down newly proposed provisions of the law and related guidance documents until the dust settles in court.
 
It’s difficult for trade associations or other industry stakeholders to publicly offer practical guidance or advice at this time, due to the law’s overall vagueness, Fabricant said. While industry stakeholders are mulling over what to do behind the scenes, offering guidance on how to comply with the law could create legal liability for those trying to make helpful suggestions.
 
“Going out there and saying this product is in, or this product is out, only creates liability for you, so we caution members against that,” Fabricant said. “’Our legal challenge is based on the fact that we don’t know what to do, so if we start making recommendations to our members about what’s in or what’s out, that would be shooting ourselves in the foot, legally. If you read the law as it’s written, there’s no way to know. For instance, if there’s a single link online to a study that suggests vitamin D builds muscle, we don’t know if that puts all vitamin D products on the hook. This lawsuit doesn’t just seek clarity, it’s to get rid of these sorts of provisions that create very real slippery slopes.”
 
The waters are even muddier for companies shipping products purchased online or through mail order. “There’s a lot about this aspect of the law that’s unrealistic,” Fabricant said, “including the costs that delivery services will have to incur in order to start conducting these brand new ID checks. Is Amazon really prepared to comply with this and go around checking IDs? Again, there’s no clarity around this aspect, just more potential for liability and extra costs.”
 
Speaking of muddied waters, Fabricant said he’s concerned that the dueling lawsuits between NPA and CRN in New York’s Eastern and Southern Districts, respectively, could potentially lead to even more confusion. “Both suits are against the same Attorney General, and both pretty much make the same challenges, but in different jurisdictions. It’s not too far-fetched to predict that the two courts won’t reach the exact same opinion on the same issue, so that’s going to lead to some confusion.”
 
A Major Turning Point  
 
Fabricant emphasized that New York’s age-restriction law is just the beginning. It could be a major turning point that sets precedent in how much regulatory power, once preempted by federal law, is afforded to state governments to regulate dietary supplements.
 
On that note, he expressed frustration over FDA’s conspicuous silence on the matter of state governments attempting to create rules that the Federal Food, Drug, and Cosmetics Act (FFDCA) preempts.
 
“You’re effectively enabling the private right to action,” he said, in which plaintiffs can take legal action against dietary supplement companies based on rules under the FDA’s enforcement purview. “When are they [FDA] going to weigh in and make clear that this is their jurisdiction?”  
 
“This is exactly why you join an organization like ours,” he continued. “This fight isn’t limited to New York, and laws could be passed in other states. There’s no excuse to sit back at this point. People have been lulled into a false sense of security because this industry’s done well financially over the years, and we have all of these resources for marketing, trade shows, and more. But a greater amount of resources need to be dedicated toward our mutual interest of creating a stable platform from which we can interface with the government over regulations going forward. It’s time to get in the game. This is the biggest challenge we’ve had in the 30 years since DSHEA was passed, and once one of these bills breaks the dam, you can bet your dollar that the rest of these bills will follow suit.”