By Todd Harrison, Partner, Venable09.08.22
The FDA recently issued its final guidance document on N-acetyl-cysteine (NAC), continuing to take the position that NAC is excluded from the definition of a dietary supplement. However, due to NAC’s long history of safe use over the past 30 years, the agency has decided to exercise enforcement discretion while it continues to evaluate whether to initiate rulemaking specifically permitting the sale of NAC as a dietary supplement. This decision is welcome news to the industry that believes FDA wrongly targeted NAC for exclusion.
However, one must be wary of the proposed mandatory product listing (MPL) requirement, as well as its companion language, which specifically states that “[t]he introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff)” is a prohibited act.
As an old proverb states, “the road to hell is paved with good intentions.” On the surface, MPL sounds like a reasonable idea. Proponents make the case that it offers transparency to the marketplace and provides FDA with information it needs to ensure requirements of the Dietary Supplement Health and Education Act (DSHEA) are effectively enforced.
These are good and honorable intentions. But most bad actors, including their manufacturers, are not going to register and list their products. Rather, only responsible companies will do so. Yes, large retailers will be able to enforce this requirement by denying their marketplace to products that aren’t listed with FDA. Again, though, I doubt that bad actors will care.
However, mandatory listing of all products and ingredients with FDA will give the agency the ability to enforce the preclusion provisions of DSHEA, as well as New Dietary Ingredient Notifications (NDIN) rather easily.
Also, as presently structured, I do not see how MPL advances transparency, as it has no real teeth to it. The MPL is at best “feel good” legislation. Feel good legislation is where Congress pats itself on the back saying “we did something meaningful,” when in fact it just made life harder for a lot of law-abiding companies.
Anyone who has bad allergies and congestion knows what I’m talking about when you are denied pseudoephedrine/antihistamine OTC drugs because Congress thought it would reduce the illicit meth trade. But all it did was make it harder for law-abiding citizens to get a drug that works while doing nothing to reduce the illicit meth trade.
Putting aside that NAC would qualify as a grandfathered dietary ingredient but for the drug approval all those years ago, there has not been any showing that NAC was marketed as a dietary supplement prior to this approval. Now, FDA could readily identify those companies marketing NAC and, instead of sending warning letters, have the Department of Justice file a lawsuit—or worse, have DOJ institute a seizure action. Boom, there it is, NAC is removed quickly and effectively from the marketplace.
Similarly, do you believe CBD would be on the market today if MPL is passed? Probably not, because FDA would have access to every major company that markets the product, and DOJ would be able to initiate seizure actions to remove it from the marketplace due to the significant drug trials conducted on CBD.
However, manufacturers of designer supplements with highly questionable ingredients would continue to market their wares because FDA would not know where to find them. Similarly, vinpocetine would not be the subject of ongoing rulemaking, even though it has been marketed for at least the last 20 years, due to obscure trials in the 1980s. Here again, FDA would only need to do a quick search to find every company that is marketing vinpocetine supplements and decide which companies to target, because its burden is less.
Similarly, FDA would be able to query all new dietary ingredients (NDI). Anyone who’s read FDA’s position on when an NDI notification is required will know that upwards of 70% of dietary ingredients would likely be considered NDIs for which a notification is necessary.
Here again, if the agency wanted to target certain NDIs, it could simply query the system and have a ready-made list—and many ingredients may not meet FDA’s narrowly defined term “for dietary substance.” Thus, once again, FDA would be able to target those companies. The problem is that the companies which should be targeted did not list their products with FDA in the first place. Thus, MPL, along with the prohibited acts language, would mainly impact legitimate companies as opposed to bad actors because it will be significantly easier to identify legitimate companies.
FDA has the authority now to act against questionable companies and dietary ingredients. But rather than doing its job, the agency wants all products listed and the new prohibited acts language it doesn’t really need to effectively regulate the marketplace. I see no reason to provide this additional authority until FDA uses its current authority.
If the agency takes issue with an ingredient, then it can institute legal action today. There is no need for new authority to do that. If enforcement dollars are an issue, then ask for more funding.
My fear is that the proposed legislation will do nothing to reduce the number of bad actors with questionable ingredients. Indeed, because of FDA’s “first bite of apple” approach to regulation, a company marketed honey adulterated with sildenafil or tadalafil. Here is a novel approach: seize the product because there is a real safety issue rather than send a warning letter. It should have been a no-brainer case.
With all that said, if MPL becomes a foregone conclusion, then at least make it easier to enforce against bad actors by adding language that if a manufacturer produces a product that is not listed with FDA, then all the products that manufacturer produces are to be considered adulterated as a matter of law.
Place the onus on the manufacturer to ensure that all products are being listed. A massive recall is not in the manufacturer’s best interest.
Finally, the prohibited acts provision is unnecessary as FDA has the authority to enforce existing statute. Squabbles between who should enforce—the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER)—need to stop. It shouldn’t matter because they belong to the same agency after all.
If NAC has shown anything, what really needs to be changed is the preclusion provisions to consider dosage, route of administration, etc. in determining whether a dietary or food ingredient is precluded. We should also have a mechanism where the company that wishes to commercialize an ingredient as a dietary supplement can submit a notification to FDA showing it’s generally safe for consumption. I wrote an article on this issue previously titled “Understanding Exclusion (Preclusion) and a Proposed Solution.” It’s worth reviewing.
Most of all, remember: “the road to hell is paved with good intentions.”
About the Author: Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
However, one must be wary of the proposed mandatory product listing (MPL) requirement, as well as its companion language, which specifically states that “[t]he introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff)” is a prohibited act.
As an old proverb states, “the road to hell is paved with good intentions.” On the surface, MPL sounds like a reasonable idea. Proponents make the case that it offers transparency to the marketplace and provides FDA with information it needs to ensure requirements of the Dietary Supplement Health and Education Act (DSHEA) are effectively enforced.
These are good and honorable intentions. But most bad actors, including their manufacturers, are not going to register and list their products. Rather, only responsible companies will do so. Yes, large retailers will be able to enforce this requirement by denying their marketplace to products that aren’t listed with FDA. Again, though, I doubt that bad actors will care.
However, mandatory listing of all products and ingredients with FDA will give the agency the ability to enforce the preclusion provisions of DSHEA, as well as New Dietary Ingredient Notifications (NDIN) rather easily.
Unfairly Targeting Responsible Companies
“Come again? Todd, a few years ago you thought product listing was a good idea. Are you changing your mind?” Well, yes, because the prohibited acts provision can be used to unfairly target companies and ingredients while allowing the bad actors to continue down their merry path.Also, as presently structured, I do not see how MPL advances transparency, as it has no real teeth to it. The MPL is at best “feel good” legislation. Feel good legislation is where Congress pats itself on the back saying “we did something meaningful,” when in fact it just made life harder for a lot of law-abiding companies.
Anyone who has bad allergies and congestion knows what I’m talking about when you are denied pseudoephedrine/antihistamine OTC drugs because Congress thought it would reduce the illicit meth trade. But all it did was make it harder for law-abiding citizens to get a drug that works while doing nothing to reduce the illicit meth trade.
Unintended Consequences
On to my examples of how this legislation that is presently fashioned creates unintended consequences.Putting aside that NAC would qualify as a grandfathered dietary ingredient but for the drug approval all those years ago, there has not been any showing that NAC was marketed as a dietary supplement prior to this approval. Now, FDA could readily identify those companies marketing NAC and, instead of sending warning letters, have the Department of Justice file a lawsuit—or worse, have DOJ institute a seizure action. Boom, there it is, NAC is removed quickly and effectively from the marketplace.
Similarly, do you believe CBD would be on the market today if MPL is passed? Probably not, because FDA would have access to every major company that markets the product, and DOJ would be able to initiate seizure actions to remove it from the marketplace due to the significant drug trials conducted on CBD.
However, manufacturers of designer supplements with highly questionable ingredients would continue to market their wares because FDA would not know where to find them. Similarly, vinpocetine would not be the subject of ongoing rulemaking, even though it has been marketed for at least the last 20 years, due to obscure trials in the 1980s. Here again, FDA would only need to do a quick search to find every company that is marketing vinpocetine supplements and decide which companies to target, because its burden is less.
Similarly, FDA would be able to query all new dietary ingredients (NDI). Anyone who’s read FDA’s position on when an NDI notification is required will know that upwards of 70% of dietary ingredients would likely be considered NDIs for which a notification is necessary.
Here again, if the agency wanted to target certain NDIs, it could simply query the system and have a ready-made list—and many ingredients may not meet FDA’s narrowly defined term “for dietary substance.” Thus, once again, FDA would be able to target those companies. The problem is that the companies which should be targeted did not list their products with FDA in the first place. Thus, MPL, along with the prohibited acts language, would mainly impact legitimate companies as opposed to bad actors because it will be significantly easier to identify legitimate companies.
FDA’s Existing Authority
So, what is the solution? Well, FDA needs to do its job. If FDA does not believe an ingredient is lawfully marketed, then it can take action, instead of taking forever to decide what to do while a marketplace grows around the new “it” ingredient. Yes, it may lose a few of those cases but the agency will also win many others.FDA has the authority now to act against questionable companies and dietary ingredients. But rather than doing its job, the agency wants all products listed and the new prohibited acts language it doesn’t really need to effectively regulate the marketplace. I see no reason to provide this additional authority until FDA uses its current authority.
If the agency takes issue with an ingredient, then it can institute legal action today. There is no need for new authority to do that. If enforcement dollars are an issue, then ask for more funding.
My fear is that the proposed legislation will do nothing to reduce the number of bad actors with questionable ingredients. Indeed, because of FDA’s “first bite of apple” approach to regulation, a company marketed honey adulterated with sildenafil or tadalafil. Here is a novel approach: seize the product because there is a real safety issue rather than send a warning letter. It should have been a no-brainer case.
With all that said, if MPL becomes a foregone conclusion, then at least make it easier to enforce against bad actors by adding language that if a manufacturer produces a product that is not listed with FDA, then all the products that manufacturer produces are to be considered adulterated as a matter of law.
Place the onus on the manufacturer to ensure that all products are being listed. A massive recall is not in the manufacturer’s best interest.
Finally, the prohibited acts provision is unnecessary as FDA has the authority to enforce existing statute. Squabbles between who should enforce—the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER)—need to stop. It shouldn’t matter because they belong to the same agency after all.
If NAC has shown anything, what really needs to be changed is the preclusion provisions to consider dosage, route of administration, etc. in determining whether a dietary or food ingredient is precluded. We should also have a mechanism where the company that wishes to commercialize an ingredient as a dietary supplement can submit a notification to FDA showing it’s generally safe for consumption. I wrote an article on this issue previously titled “Understanding Exclusion (Preclusion) and a Proposed Solution.” It’s worth reviewing.
Most of all, remember: “the road to hell is paved with good intentions.”
About the Author: Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
