CRN and AHPA are on record in support of the Dietary Supplement Innovation Act, H.R. 10336. The objections to this legislation appear to rest largely on the premise that the bill creates a new prohibited act under the Federal Food, Drug, and Cosmetic Act. It does not.
Section 301(ll),[ 21 U.S.C. §331(ll)], already makes it a prohibited act to introduce into interstate commerce a food to which certain approved or investigational drugs have been added. Dietary supplements are generally deemed food under the FD&C Act. So that provision, already in the law since 2007, creates a prohibited act for marketing a supplement that contains a precluded ingredient. FDA has invoked it in enforcement actions involving food products containing precluded drug ingredients, including a 2023 warning letter to Amazon involving a product containing tadalafil and several letters regarding CBD in food products. Section 331(ll) can already be equally used for supplements as for traditional food.
The better question is whether H.R. 10336 improves the law that is already there. It does so in several important ways.
First, it addresses secret INDs. Under the existing framework, FDA can take the position that an investigational new drug application triggers preclusion even when supplement companies have no practical way of knowing the relevant clinical investigation exists. A company can invest heavily in an ingredient only to learn later that a pharmaceutical company got there first. The Dietary Supplement Innovation Act would require the existence of the relevant clinical investigation to have been made public. No more secret IND filings to trigger preclusion and no more regulatory hide-and-seek.
The bill also protects grandfathered dietary ingredients—ingredients marketed as a dietary ingredient before October 1994. They can’t be subject to drug preclusion. That matters for ingredients such as NAC and pyridoxamine.
It replaces the vague phrase “substantial clinical investigations” with a more objective Phase 2 or Phase 3 threshold. Companies should not have to guess what FDA or a federal judge may someday decide is “substantial.”
The legislation also addresses abandoned drug development. If the relevant clinical investigations have remained inactive or withdrawn for seven years, or the sponsor publicly announces that development has been discontinued, the preclusion barrier can be lifted. That can’t happen today. It responds directly to situations in which a failed or abandoned drug program can block supplement use despite the drug company’s disavowal of a drug use? Anyone remember homotaurine? The industry is evolving and It’s not hard to imagine a pharmaceutical company would have a supplement division and decide which is a better path to market while complying with all relevant regulations for dietary supplements.
The legislation would also allow FDA to use an administrative-order process to create exceptions to drug preclusion rather than relying on cumbersome notice-and-comment rulemaking. Anyone who has followed the NAC saga since 2021 knows how consequential delay and uncertainty can be for companies and consumers.
Another important change is judicial review. Under the bill, specified FDA communications asserting a Section 301(ll) violation, including warning letters and statements on FDA-controlled websites, could be challenged immediately, regardless of whether they qualify as “final agency action.”
Today, FDA can announce its position on an ingredient and retailers or online platforms may respond by halting sales before the affected companies have a practical way to get into court. H.R. 10336 would provide a path to review, with the government bearing the burden of proving the violation.
The bill also directs FDA to consider real-world differences between drug and supplement uses of a substance, including route of administration, dosage or serving amount, concentration or composition, and safety considerations.
Those distinctions matter. A substance administered intravenously at pharmaceutical doses is not necessarily the same proposition as that substance consumed orally at much lower levels in a dietary supplement. Drug preclusion should recognize those differences rather than pretend they don’t exist. There can be a marketplace for both.
One proposed alternative approach is to just cleanly and simply strike the IND clause from Section 201(ff)(3)(B)(ii). The attraction of simplicity is understandable. But that approach would leave the other problems untouched: no Phase 2 or Phase 3 threshold, no abandoned-drug off-ramp, no expedited exception process, no requirement to consider differences in use, and no avenue for immediate judicial review.
Those aren’t “regulatory safety valves.” They are substantive reforms responding to actual problems our industry has experienced.
This approach is like saying: “We know this one electrical breaker keeps tripping, so replace the breaker and leave everything else alone.” Our approach is: “Yes, replace the breaker—but while the panel is open, fix the other known defects that have already caused outages: mislabeled circuits, obsolete wiring, no easy shutoff, and no way to challenge a bad inspection without shutting down the house.”
Another option is to strike the entire discussion of drug preclusion from 201(ff)—eliminate drug preclusion completely. Such a frontal attack on drug preclusion would almost certainly be opposed by pharmaceutical companies with no chance of passing. H.R. 10336 is a pragmatic solution that brings both sides together vs one that is likely to engender immediate and resolute opposition.
There is room for good-faith debate over whether the Dietary Supplement Innovation Act can be improved. Both sides should welcome that debate. But it should begin with an accurate understanding of what the bill does.
The legislation does not create Section 301(ll). It takes an existing, imperfect drug-preclusion framework and adds transparency, clearer standards, off-ramps for abandoned development, procedural protections and judicial accountability.
Drug preclusion needs fixing. The real debate is which reforms will give responsible supplement companies greater certainty to innovate while preserving consumer access to lawful ingredients. That’s a conversation worth having.
