May 25, 2022
This article is part of Natural Products Insider’s periodic updates from trade associations and other major stakeholders. These columns are meant to keep industry readers updated on the organizations’ activities and priorities, as well as to issue calls for action. The op-ed commentaries represent the views from the authors and/or the organizations they represent, not necessarily the views of Natural Products Insider or its editorial staff.
The Natural Products Association (NPA) and others remain disturbed that dietary supplements are included in legislation to reauthorize the FDA user fee programs. Our industry has never been part of the “UFA” (user fee amendments) reauthorization package in the past, and we shouldn’t be now or in the future. Any legislation related to dietary supplements should stand or fall on its own merits. This proposal deserves its hearing in the Senate Health, Education, Labor and Pension (HELP) Committee rather than insertion in a discussion draft of unrelated legislation.
Simply put, including our industry in this package is no way to make policy on dietary supplements. Without a hearing on the merits, we’ve been inappropriately dragged into a broader negotiation of legislation around other products and commodities that FDA regulates. We’re being traded for what may be a greater priority to other senators within the legislation.
We also find it odd that the arguments about the need for “transparency” in dietary supplements don’t extend to transparency or public listing of information about other FDA-regulated commodities, such as foods and medical devices. It’s funny that FDA seemed to have a pretty good handle on how many ingredients haven’t filed an NDIN (new dietary ingredient notification) in its most recent draft guidance.
So much for not being able to see what’s in the marketplace.
The new “prohibited act” language inserted in the May 17 discussion draft of the user fee reauthorization bill, this year called FDA Safety and Landmark Advancements (FDASLA) Act, clarifies what’s driving these provisions goes well beyond the desire for transparency, a collection of labels or mandatory product listing (MPL). Instead, it seems driven by a desire to allow FDA to “bar the door” from listing anything it wishes to keep out of dietary supplements under Section 201(ff)(3)(B) of the Federal Food, Drug and Cosmetic Act (FDCA).
The FDASLA Act would make it a “new prohibited act” to introduce into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under Section 201(ff).”
The language above is not a requirement related in any way to MPL. This would give a “science-based” agency a way around rendering a scientific opinion on ingredients and allow the agency to say “no” to ingredients like CBD administratively. It would create a statutory basis to support FDA’s long-standing bias against our industry and misapplication of Section 201.
FDA’s opinions and actions on Section 201 have been arbitrary or capricious. This is apparent from its treatment of ingredients like CBD and NAC (N-acetyl-L-cysteine). At one time or another, FDA has stated these ingredients are excluded from the definition of a dietary supplement due to its misapplication of the exclusion criteria. CBD is the poster child for this behavior, with FDA speaking out of both sides of its mouth for the last four years.
While some governments like Ireland have provided their people with a safe daily level of consumption, FDA has told Congress they are “confused,” and lawmakers have let the agency get away with this and given FDA more money to address CBD. Yet, FDA still has done nothing to resolve the matter.
The introduction of the “prohibited act” language clarifies the U.S. Senate is satisfied with FDA’s treatment of CBD and hemp farmers. It sends the message that FDA’s ability to threaten CBD administratively is more important to the Senate than pushing FDA to set a safe daily consumption level, which would stabilize the marketplace for hemp producers and add a layer of safety for Americans who seek hemp-based products.
CBD is not the only ingredient where FDA has harmed the industry regarding its interpretation of Section 201. Our organization is suing FDA in federal court on NAC at present. NAC is an amino acid that was on the market prior to enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). During the pandemic, almost 30 years after its introduction to the market and without any compelling public health rationale, FDA decided to destabilize the NAC marketplace administratively by saying it doesn’t fit in the “dietary supplement” category. A lawsuit was the only way to bring FDA to the table and get the agency to recognize its error. FDA is now reversing course via plans to exercise enforcement discretion, as expressed in its recently published draft guidance.
We all agree addressing safety is FDA’s primary job, but not once in the minimal public discussion on the need for MPL has an actual safety issue been cited. The ingredient (tianeptine) raised in Senator Dick Durbin’s (D-Ill.) recent floor speech as his top example of the need for MPL is an unapproved drug. FDA could have taken action for several months against this ingredient, yet the agency did nothing with its authority.
Moreover, Senate HELP Committee Chair Patty Murray (D-Wash.) recently excoriated FDA’s Center for Food Safety and Applied Nutrition (CFSAN) over its dysfunction and the inconsistent and irresponsible use of its existing authorities. On top of that, it’s astonishing Congress is proposing to give CFSAN another big project (in the form of an MPL database) considering its handling of the infant formula crisis.
On the merits of MPL, we want to reiterate a few essential points:
A public database of products is unnecessary to promote public health and inconsistent with the facility registration provisions of the Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002). Congress decided 20 years ago there was a compelling reason to protect information about food production from falling into the hands of people with malicious intent, and the discussion draft’s limited attempt to shield a few pieces of this information is insufficient.
Any product listing should be for FDA’s eyes only, absent a compelling public health rationale that we have not seen or heard yet. Since U.S. law does not preempt state causes of action against dietary supplements, a cynic might suggest a genuine reason for a public database of nutritional supplements is to support private litigation against our industry. Limiting the database to FDA’s eyes only might reassure such cynics.
Any MPL language should include a provision that prohibits FDA from excluding or removing products from the listing unless and until the product is subject to final agency action. An agency action is final if (1) “the action marks the consummation of the agency's decision-making process” and (2) “it is an action by which rights or obligations have been determined, or from which legal consequences will flow.” This is the only way the industry can preserve its due-process rights should a dispute arise with the agency, like the current disputes over CBD and NAC. Otherwise, FDA could still use MPL to deny or de-list products containing disputed ingredients, even if the “prohibited act” language discussed earlier was removed (as it should be) from the bill.
“Prohibited act” language in FDASLA Act
You may be wondering how the “prohibited act” provision ended up in the FDASLA Act. After seeing the standalone “Dietary Supplement Listing Act of 2022” (S. 4090) introduced by Sens. Durbin and Mike Braun, the U.S. Department of Health and Human Services (HHS) influenced the addition of the above provision in the HELP Committee discussion draft. Back in? Yes, the “prohibited act” language was initially in discussion drafts between Braun and Durbin on their bill. Braun apparently wanted it out, and it came out, but now it’s back in a piece of must-pass legislation.
We wouldn’t be in this position without the supporters of S. 4090. Their support stemmed from appealing to everyone versus appreciating what we already have. Advocates of MPL have become very quiet since the appearance of the language of the FDASLA Act, which was actually worse in many ways than the standalone bill introduced by Braun and Durbin. The initial supporters of MPL must have thought they could control the opinions and actions of members of Congress and consumer groups who have been opposed to the industry for decades. That’s a welcome-to-Washington, D.C.-moment for some who don’t understand unintended consequences.
Why does it matter?
Some people argue FDA hasn’t sought criminal penalties against marketers of CBD or NAC, even though the agency has maintained these ingredients are excluded from the definition of a dietary supplement. The “new prohibited act” language, the argument goes, isn’t a game changer for industry. While I am no lawyer, I did spend some time administering the FDCA while overseeing FDA’s Division of Dietary Supplement Programs. It would seem that a company in the dietary supplement industry, including those selling CBD and NAC, would favor as many procedural hurdles as possible to enforcement action.
Exclusion is not the same as a prohibited act. A prohibited act is presumed to be egregious by definition. I do not want to be adulterated or misbranded by definition. The plaintiff’s bar should not be able to bring class action lawsuits against manufacturers and marketers of dietary supplements before FDA makes an express and final determination that the exclusion in Section 201 applies. If putting CBD into a dietary supplement is interpreted by FDA as a “new prohibited act,” class action lawyers will move forward with demand letters and complaints, even if there is no final determination that the ingredient is actually excluded. We can’t afford to be in this position.
The fallout will also hit retailers. Wouldn’t big e-retailers stop selling CBD products if FDA issued a warning letter that included the prohibited act language? Also, if there is a public-facing listing, FDA won’t be listing ingredients if it believes they are excluded from the definition of a dietary supplement under Section 201. So, unfortunately, that'll result in these same e-retailers refusing to sell CBD or NAC products since they're not listed with FDA.
What does MPL and all this commotion over FDA’s proposal achieve for the industry? Not a thing. We urge you to read criticisms of industry in support of the legislation expressed by the likes of Pew and the American Medical Association (AMA). Their statements underscore they will always be critical for no apparent reason, speculating our products pose safety issues without the data to support it. This is no different than someone claiming efficacy without the data to substantiate their representations.
MPL provides no guarantee from Congress or the states that we won’t be subject to the ridiculous attacks on the industry, like the current one in the state legislatures claiming we are responsible for eating disorders in teenagers rather than the 7-plus-hours-a-day teens spend on social media looking at photoshopped images and videos.
MPL does not produce the benefits we really need like tax breaks for keeping people employed and healthy during the pandemic, WIC (Women, Infants and Children) coverage for folate for expecting mothers and intellectual property protection. Industry and the American consumer get nothing except limited access and increased costs. Kudos to the American Herbal Products Association (AHPA) and its president Michael McGuffin for assessing potential MPL compliance costs here; they’re real and will only increase the burden for regulated industry.
Where do we go from here?
This belief in MPL is a particularly dangerous one that has seduced some people. Rather than seeing and appreciating the unique space their market occupies as a reflection of their offering, and a point of strength, people see it as a mark of shame. Some become agitated because 100% of the market doesn’t love us. They wrongfully assume it must be because they’re doing something wrong—dismissing all the good that has been done. However, the issue with fixing such things is that in doing so, you undermine the very thing that made you successful in the first place.
Today, some have chosen to undermine what made us successful in the first place. However, the rest of us will leave no stone unturned to make sure that doesn’t happen. If you’re in the second group—and I hope you are and thank you if you are—please take 30 seconds to write to Congress. Even if you have before, let U.S. lawmakers know there can be no dietary supplement reforms without a real debate. And that will not happen in earnest if supplement language is included in the FDASLA Act.
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