Washington, D.C.—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes theDurbin-Braun premarket approval concept. The Natural Products Association (NPA) is cautioning that this would be damaging to the industry.

Daniel Fabricant, Ph.D., President and CEO of NPA, called the legislation “radical and dangerous,” pointing out that it would weaken the Bioterrorism Act. “Last time I checked, dietary supplements are not drugs, biologics, or medical devices, so why is Congress or anyone supporting non-germane legislation that will only add costs to consumers who are doing all they can to stay healthy is extremely troubling? Groups who have supported this legislation have stated there are protections for technical disagreements with the FDA like those with hemp, CBD, NAC, and several other products. However, if this legislation were to pass, it is abundantly clear these products would be eliminated from the market.”

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

Bioterrorism Concerns The legislation would require supplement manufacturers to supply FDA with information not only about the product, but about the entire supply chain, which would then be made public. NPA's concern is that this is in some cases redundant, in some cases pointless, and in some cases dangerous.

Speaking withWholeFoods Magazine, Dr. Fabricant explained: “This is completely at odds with the Bioterrorism Act. If this were to pass, people would have a complete record of all points in the supply chain in one electronic database. This would leave the safety of our supply chain totally vulnerable. Additionally, manufacturers have to list every place it is sold/retailed? What benefit is that? The FDA already has access to information regarding who is making dietary supplements, distributing them, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events. These requirements fall under facility registration, the Bioterrorism Act, structure/function claims, New Dietary Ingredient notifications, and adverse event reporting. Some of the information the FDA has at its disposal is not publicly available, and for a good reason.”

The legislation would fail to address the actual problem, according to Dr. Fabricant: FDA’s disorganization, and its failure or refusal to use the information already at its disposal.

Product Removal The legislation states that it would be prohibited to introduce products into interstate commerce if they are marketed as a dietary supplement, but don’t meet the legal definition of a dietary supplement—which would hit cannabidiol (CBD), N-acetyl cysteine (NAC), and probiotics, to name a few.

Due to FDA's insistence that those products aren't dietary ingredients, “this is the biggest concern,” Dr. Fabricant toldWholeFoods. “Because the bill is unclear, there is no way to remedy this in a timely manner. This is where FDA can, by not listing a product, effectively take away its ability to be sold on the market. Large retailers will use this list to decide whether they sell a product or not. So not appearing on the list due to a technical disagreement with FDA—not a dispute over safety or disease claims—could take away your whole business with the stroke of a keyboard. FDA has done nothing on CBD in four years, and with the tools provided in this bill, could wipe it out altogether due to the agency’s stance/interpretation on Section 201(ff)(3) of FDCA. If you have a new dietary ingredient notification and are compliant with the law, but FDA disagrees with your opinion on safety or daily dosage, do you think they're going to list your product? Also, under this legislation, knockoff ingredients or copycat ingredients altered chemically can flood the market absent any action from the FDA. How is that a good thing?”

Increased Administrative Power Dr. Fabricant adds that NAC should be a warning sign—while FDA has announced apolicy of enforcement discretion, this bill would mean they wouldn’t have to bother. “The language here would be in direct contravention with 201(ff)(3). Anything that FDA says was a drug first, whether accurate or not, would be prohibited. Not on safety, not on disease claims, but on an administrative rendering, an opinion, one that—as we’ve seen with NAC—is sometimes arbitrary or capricious.”

And speaking of administrative decisions, Dr. Fabricant toldWholeFoodsthat this bill would let FDA use administrative decisions to deny a product access to market. “FDA reserves the right to determine whether a product is eligible to get on the list or not by rendering it complete or incomplete. This is not only vague, but makes this administrative rather than scientific. If we look at what ‘incomplete’ means for an NDI filing, it means that your product is still in violation of the law. If the agency disagrees with claims or ingredients, do we really think they'll list the product?”

Dr. Fabricant continued: “Those who supportmandatory product listinghave gone silent on tough questions regarding how the bill impacts CBD, NAC, etc. It's clear that the FDA will not take ‘the good, the bad, and the ugly’ and put it on the list. They will reserve the right to call balls and strikes while the industry is left without recourse. Also, why, if there is a need for reform, is this the only reform being discussed when there are a myriad of positive things to address? For instance, a regulatory pathway for CBD, enhanced health claims for things like vitamin D, multivitamins for WIC and SNAP, state pre-emption, the list goes on.”

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided FDA Issuing Enforcement Discretion Guidance on NAC The Natural View: Regulatory Update with NPA’s Kyle Turk Pay Homage to the Past with a Promise for the Future

NPA is working to fight the bill, both byreaching out to key figures in the governmentand by activating its grassroots network, with forms for contacting representatives here. Dr. Fabricant says NPA isn't alone: "There are many more people opposing the bill than those in favor. Tens of thousands of emails have been sent to Congress in opposition to the legislation. People don't want their choices restricted or their costs to increase unnecessarily."

The full text of the draftcan be read here, and a section-by-section breakdowncan be read here.

WholeFoods Magazine will continue to share the latest developments, as well as industry perspectives.