At the 2022 NYSBA Annual Meeting, a panel discussion focused on intellectual property and FDA’s protection of it, or lack thereof. Mark Ullman, Of Counsel, Rivkin Radler, moderated the meeting, and opened with an anecdote regarding Mitsubishi Gas Chemical (MGC): The company spent large sums of money going through the NDIN process, including proving the safety of their pyrroloquinoline quinone (PQQ)… and then when its NDIN was approved, the market was flooded with PQQ that hadn’t gone through the same rigorous process. MGC ran a campaign about it, and a major competitor submitted an NDI—which included one study in which all the rats that took the product died, and one study in which kidney lesions were found on the rats that consumed the product. FDA found it unsafe. But instead of removing the product from the market, FDA concluded the process, and the competitor continued selling this ingredient, and a few months later submitted a GRAS notification—which, as though the NDIN process had never happened, FDA approved with no questions asked. “Iwrote about this in 2014,” Ullman said, “and now it’s 2022. Has anything changed in FDA?”
The answer was a resounding no.
“It appears something is amiss in the agency tasked with controlling what comes in through our borders,” said Mark LeDoux, Founder, CEO, and Chairman of the Board of Natural Alternatives International (NAI). He had a similar story: NAI offers a CarnoSyn brand of beta-alanine, which in 2019 obtained NDI status from FDA. And after his company spent the money to do it, other companies started importing beta-alanine, some of which was made with recombinant technology from E. coli, without ever submitting an NDIN. His view: “Shouldn’t people at FDA be asking if it’s safe? You can bring in whatever you want and do whatever you want until someone says you can’t, but the agency tasked with doing it is under-staffed, underfunded, or something else is always coming up.”
Kevin Bell, Partner at Arnall Golden Gregory LLP, on behalf of LeDoux, asked the Office of Dietary Supplement Programs (ODSP) to do something about it. “We had several meetings with people in ODSP and CFSAN, in which we showed them how much beta-alanine was being imported that wasn’t CarnoSyn. We brought them samples. We had company names and addresses, and explained that we believed it posed enough of a safety risk that we thought FDA should be asking the question—do these companies have safety data, do they have an NDI? They said we gave them too long a list of companies to investigate, so we shortened it, we spoon-fed them everything. And eventually we sent a citizen’s petition.”
Theresponse to that petition—signed by Cara Welch, at the time Acting Director of ODSP—states that NDINs are necessary only when the article is not available in the food supply in a form in which the food has not been chemically altered, and that FDA doesn’t have that information regarding beta-alanine, so it can’t require NDINs for beta-alanine ingredients. The letter stated that the citizen’s petition did not provide specific evidence that beta-alanine being imported into the country was adulterated, so FDA didn’t have enough proof to devote resources to blocking the entry of these materials into the country. FDA further noted that there have been no adverse events reported, and that the agency therefore sees no safety risk to investigate. The letter concluded: “At this time, we do not have concerns about beta-alanine that warrant the further investment of FDA’s limited resources.”
Bell’s reading: “We gave them all this information, and the response was: ‘Did anyone die?’ Is that the standard? We have to wait until someone dies first? That’s unacceptable.”
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And while FDA asserts that it doesn’t have the resources to go after everyone, Bell feels that the agency doesn’t have to. “You can put up speed limit signs, but everyone’s going to speed until you hand out speeding tickets. You need enforcement. But FDA is in charge of that. And if you ask them to enforce it and they say no, there’s nothing else you can do about it, which is a scary proposition, especially when you can walk in and say ‘we’re here to help, we have information, what else do you need,’ but they said in the letter that they weren’t going to do anything until someone was injured or hurt. I don’t think that’s what DSHEA was intended to mean. The process is really disheartening.”The end result, according to Bell and LeDoux, is that there’s little incentive to prove safety at all, no matter how often FDA says it wants more voluntarily submitted NDINs. “What’s the incentive of studying a product and proving safety if the government won’t protect it?” LeDoux asked. And, he said, in the end, that safety can backfire—because once there’s a market for it, “people around the world can go, ‘well, we can make this in a bathtub,’ and if it looks sorta similar and maybe smells the same, then the government won’t have a problem with it.” And that, he feels, is a dangerous precedent to set.
