Guest Article

CRN says furor about new prohibited act is much ado about nothing

©Getty Images - Ildo Frazao
©Getty Images - Ildo Frazao

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Much has been made in recent weeks about the Senate HELP committee’s inclusion in the FDA user fee legislation of a new prohibited act related to dietary supplements. We think this handwringing is sorely misplaced and is creating a false flag to justify certain stakeholders’ opposition to the bill. In our view, the heated rhetoric is not supported by the text or the intent of the new provision.

The same section of the massive FDA user fee legislation that would establish mandatory product listing for dietary supplements also includes a new “Prohibited Act” under section 331 of the Food, Drug & Cosmetic Act (FD&CA). It would make illegal “the 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 [the definition of a dietary supplement in the Act].”

On its face, the provision does not appear that objectionable—a product marketed with a Supplement Facts label or a dietary supplement Statement of Identity that nevertheless fails to be a dietary supplement is illegal.  

No new authority

Since this provision was inserted by the Senate HELP committee several weeks ago, some corners of the supplement industry have vociferously objected to the legislation, claiming this provision would grant new authority to FDA allowing it to prosecute products that contain either cannabidiol (CBD) or N-acetyl-L cysteine (NAC), two politically-charged ingredients, in light of FDA’s views on CBD and the dust-up over the legal status of NAC over the past year.

The truth is that FDA already has ample authority to pursue either CBD or NAC under existing provisions of the law—it has simply chosen not to. If one accepts FDA’s view that both CBD and NAC are precluded from use in supplements because they were previously approved as drugs (we don’t accept that position, but for sake of this argument, let’s presume we did), then the FD&CA already makes it illegal to include either one in food. (Remember, dietary supplements are “food” under the law.) Section 331(ll) expressly makes it a Prohibited Act to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act [21 U.S.C. 355] or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. The power to declare the marketing of a supplement with CBD or NAC a “prohibited act” already exists in law.

Existing authroity cited in honey warning letters

If the industry had any doubt about the applicability of that provision, it was clarified two weeks ago when FDA issued warning letters to four companies marketing honey-based products as food or dietary supplements that included Cialis (tadalafil) and Viagra (sildenafil), which are FDA-approved drugs used to treat erectile dysfunction. In those letters, FDA cites section 331(ll) as the basis for the illegal conduct. All the commotion about the potential effects of the new legislative language is nothing new—FDA already has the authority, but has chosen not to use it.

Let’s say that again for complete clarity: all the predictions that passage of this new provision would be the end of the supplement industry, and particularly ingredients like CBD and NAC, are unfounded—the supposed power that this provision would give to FDA is already possessed by the agency. 

So the next logical question is whether FDA needs this new authority at all. We are a little more circumspect on this issue. After all, section 331 already lists as other Prohibited Acts both “[t]he introduction or delivery for introduction into interstate commerce of any food, … that is adulterated or misbranded,” and “[t]he adulteration or misbranding of any food, … in interstate commerce.” When the agency becomes aware of a product containing an illicit substance, why not just invoke these two provisions and proceed with criminal enforcement? Does FDA really need this new provision? The answer is likely “yes.”

We admit to being skeptical about FDA’s current interpretation of the limits of its authority. But that position is troublesome for efficient enforcement by CFSAN. FDA has previously noted that a product marketed with a Supplement Facts​ label but not containing a lawful dietary ingredient cannot be prosecuted as a dietary supplement by CFSAN because it technically does not meet the definition of a dietary supplement. Thus, FDA apparently believes these products fall into a no man’s land and can only be prosecuted by CDER as an unapproved new drug.

Substances that fall through the cracks

FDA officials have opined publicly for years that the FD&CA does not address substances that have not been previously approved as drugs: substances like DMAA, kratom, designer anabolic steroids, and analogs of sildenafil, to name a few. These are the ingredients that have most vexed the agency and frustrated companies trying to do the right thing while watching products containing these illicit chemicals pop up in the otherwise reputable marketplace. Ironically, because these are not approved drugs, they are not precluded by the language of 331(ll). That provision only applies to articles that were previously marketed legally as drugs, or studied in substantive clinical investigations as drugs. Often these illicit chemicals are neither. 

Products containing these illicit substances are not technically dietary supplements because they don’t contain a legal dietary ingredient. Unlike other regulated categories, satisfying the criteria for a dietary supplement requires more than intent. For example, a drug is “intended​ to treat, cure, prevent, or mitigate a disease;” a cosmetic is an article “intended​ to be rubbed, poured, sprinkled, or sprayed on, … or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance.” But a dietary supplement requires more. The product must be intended to supplement the diet, and​ contain at least one legitimate dietary ingredient. 

Clarifying a de facto existing authority

The new Prohibited Acts  provision just makes FDA’s job a little easier because the agency doesn’t independently have to prove the product is adulterated or misbranded in addition to having an illegal ingredient. Putting in the illegal ingredient is enough. Responsible companies have been urging FDA to act more aggressively and have long believed FDA already has authority to go after illegal supplements. If FDA believes it needs to make this explicit in the statute, why should the industry object? 

Maybe it’s time to stop seeing ghosts around every corner and give FDA the authority it believes it needs to clean up the industry. The new Prohibited Acts provision does not convey new authority on FDA with respect ingredients that are already ensnared by the drug preclusion debate. Rather it gives FDA new authority to address illicit substances that have never been marketed as drugs, or even seriously studied for their potential effects, but that are marketed as supplements nonetheless. And it allows FDA to address these illegal products more expediently—which is exactly what responsible industry has been asking for. To oppose this provision would be much ado about nothing and would turn this opportunity into a Shakespearian tragedy instead.

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