We recently learned inaccurate and misleading report language was included into an appropriations bill in the U.S. House of Representatives. Fortunately, the report language does not carry the force of law, but it was still an unwelcomed surprise.
The language mirrored some proposals by anti-supplement groups like The Pew Charitable Trusts and stated, “[The] Committee is concerned with the lack of robust regulation of dietary supplements, some of which cause an estimated 23,000 emergency room visits per year that include life-threatening illnesses and deaths, and encourages the FDA to issue regulations requiring mandatory product listing and registration to create transparency in the supply chain.”
Huh? Someone in the Appropriations Committee clearly didn’t do his or her homework, because this estimate was a part of a study published in the New England Journal of Medicine, which the Natural Products Association (NPA) criticized for flawed methodology and conclusions.
But what does “encourage” mean and should we be concerned? It means the report language isn’t exactly high on the list of priorities. So aside from the reputation slight, which we aren’t happy with, the possibility of Congress adopting new requirements for the dietary supplement industry seems slim, right? Wrong.
Next up are the Senate appropriators. Powerful and long-time industry critics like Sens. Richard Durbin (D-Illinois) and Patrick Leahy (D-Vermont) have a history of proposing misguided legislation when it comes to nutritional supplements. Generally, appropriators shouldn’t give new legal authorities as a matter of funding the government. But given the pro-regulatory stance of the Biden administration, it’s not surprising to see this backdoor approach to more cumbersome and unnecessary rules.
What is surprising is the Biden administration is effectively doubling down on a proposal from the previous Trump administration, which was criticized repeatedly by the current administration. The surprises don't end there. While some in the industry support yet another product registry—in addition to the current dietary supplement product label databases —we would hope they never signed up for a partner in that endeavor—Pew—to paint the industry as life-threatening.
Why? When you search “Pew” and “Supplements,” you find the exact same language as the appropriations report titled, "Stronger Dietary Supplement Oversight Still Needed to Protect Consumers.”
Pew and others have advocated for a mandatory product registry, yet they’ve failed to provide industry leaders with any evidence it would have a material impact on public health. Meanwhile, FDA is failing to enforce the laws and regulations already on the books. Pew has said for years, “At a minimum, supplement manufacturers should be required to provide FDA with basic information such as product name, ingredients and label for every product sold…Known as product listing, this requirement would increase transparency and boost FDA’s ability to respond to emerging concerns.” But FDA already has access to this information through various resources and tools, such as the National Institutes of Health (NIH) Dietary Supplement Label Database. Yet, FDA fails to use this resource and many others.
It’s no secret groups like Pew and others have attacked the industry for years. They’ve tried and failed to over-regulate dietary supplements. The difference this time is it’s politically convenient for the current administration to piggyback and support a cumbersome policy initiated by groups like Pew during the previous administration.
Did people in the industry really think making an alliance with a group that only wants to see the industry go away would yield a partner or process they could control?
We are letting Congress know that rather than questioning the undisputed safety record of nutritional supplements used by two thirds of all Americans, FDA should focus on the following: using its enforcement powers to set a safe level of consumption for CBD; conduct more facility inspections; and ramp up its efforts to enforce the new dietary ingredients notification (NDIN) requirement in the law, especially when it comes to imports.
And there are more surprises. As Natural Products Insider chronicled so well in a recent series, FDA claims a lack of resources is limiting its ability to enforce the NDIN requirement at the U.S. borders. Some resources may have been diverted from inspections due to COVID-19 concerns, yet we still have not seen a funding proposal to return inspections to the pre-COVID level, enhance much needed foreign inspections or fill in the gaps on enforcement against NDIs imported into the U.S. and out of compliance with FDA requirements. This is despite the fact pre-COVID inspections were significantly lower than 5 or 10 years ago, even with years of increased funding. Is that a sincere effort to use existing laws to protect Americans? Is that an effort to effectively regulate the industry? As the former director of FDA’s Division of Dietary Supplement Programs, I can attest the system works effectively, provided the requisite willpower is applied.
While FDA will likely receive more funding, the agency must be held accountable. Otherwise, FDA will continue to be a stubborn and stagnant agency more focused on acquiring new authorities than working with the tools they already have.
Some voices claiming to represent industry’s best interests need to drop their obsession with new legislation, just so they can say they did something. Instead, we should use the process to ensure FDA—as the regulator—is inspecting more facilities to current good manufacturing practices (cGMPs) and enforcing the NDIN requirement, especially against NDIs imported into our country. These aren’t challenging concepts. It’s common sense.
If children are granted a larger allowance for ignoring their chores, people would question that parent’s logic. The same is true here. We should be very careful about signing onto shortsighted proposals and rewarding bad behavior. This is especially true when you consider the tremendous role that supplements played during the pandemic and the growing popularity of natural products in health and wellness.
Daniel Fabricant, Ph.D., is CEO and president of the Natural Products Association. He previously was director of FDA's Division (now "Office") of Dietary Supplement Programs.