A new bill could close the back channel that lets drug companies threaten your access to supplements—and Congress needs to hear your support now. Action Alert!
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THE TOPLINE
- Drug preclusion rules can block supplement sales because of earlier drug approvals or research, putting affordable options at risk.
- The battles over NMN, CBD, and NAC show why consumers need lasting protections.
- Urge your representative to support H.R. 10336, the Dietary Supplement Innovation Act, and your senators to advance companion legislation.
A New Bill to Protect Your Supplements
A new bill in Congress would help protect your access to supplements by making it harder for Big Pharma to create monopolies on natural ingredients—something we at ANH have called the FDA back-channel that allows drug companies to turn supplements into drugs.
The Dietary Supplement Innovation Act, H.R. 10336, would replace confusing, pro-Pharma rules with stronger protections for consumers and supplement makers. Congress needs to pass it.
At stake is a basic question: Should a company’s decision to develop a drug enable it to squeeze supplement versions out of the market? Under current law, that can happen—and it has already led to key natural products being banned.
What the Bill Would Change
H.R. 10336 would not eliminate the back-channel, but it would significantly narrow its scope. It would:
- Protect longstanding ingredients. Qualifying ingredients sold in foods or supplements before October 15, 1994, would receive explicit protection from drug preclusion.
- Stop secret filings from deciding access. Preclusion would depend on publicly disclosed Phase 2 or Phase 3 trials. A confidential filing or early-stage research alone would not be enough, and earlier food or supplement sales would be protected.
- Reopen the door after abandoned research. An exception to drug preclusion would apply when all qualifying trials have been inactive or withdrawn for at least seven continuous years, or the sponsor publicly announces that development has stopped.
- Make exclusions easier to challenge. Certain FDA letters and website statements could be challenged immediately in court, with the government responsible for proving a violation.
- Require FDA to consider meaningful differences. When evaluating prior-marketing protections, FDA would have to consider differences between drug and supplement uses—including dose, composition, how they are taken, and safety.
These changes will improve supplement access and make it harder for Big Pharma to create monopolies on natural ingredients.
Speaking to the bill, ANH General Counsel, Jonathan Emord, said, “Overall, this is a good bill, but it should be revised in several respects. I would expand the grandfather provision to make clear that the substance does not have to be labeled as a food or dietary supplement but instead must be shown to have been ingested for its taste, aroma, nutritive value, or effect on a body structure or function without reference to a disease before October 15, 1994, to be eligible for grandfathering.”
He continued: “I would also reduce the 7-year requirement to one year for inactive investigations. I would strengthen the provision on routes of administration, dosage, concentration or composition to state that there would be no drug preclusion if the dietary supplement or food did not have the same route of administration, an effective drug dose such that it would produce a treatment effect, and the same or a worse safety profile as the drug. I would specify not only that FDA has the burden of proof to establish drug preclusion—as it currently provides—but that FDA must prove its case by clear and convincing evidence.”
How Pharma’s Back Channel Works
In plain English,“drug preclusion” simply means that FDA, invariably following pressure from a drug maker, has the right to ban an ingredient as a supplement if it was approved or qualified for investigation as a drug before it was sold as a food or supplement.
We’ve been calling for this broken policy to be reformed for a long time. For starters, recall that, for any supplement that is considered “new”—that is, it came to market after 1994—the manufacturer must submit a “new dietary ingredient” notification (NDIN) to lawfully market that ingredient. But the FDA has yet to issue a final guidance describing which supplements are considered “new.” In fact, one of the major problems the FDA’s interpretation so far is that even minor “chemical alterations” that occur with modern manufacturing would be enough to make your vitamin D a “new” supplement. Supplements marketed before 1994 are grandfathered and do not require a NDIN, but the FDA has issued no definitive list of those products.
The bottom line is this: it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs.
So, here’s what Big Pharma can do: a drug company begins the process of studying an ingredient as a drug. If that process predates food or supplement sales—and clinical trials begin and become public—FDA can block the ingredient from being sold as a supplement. Because the initial drug filings are confidential, supplement makers may not know they are entering a race someone else has already started.
No Supplement and No Medicine
Worse still, drug preclusion can shut consumers out of an ingredient even when the drug being developed never reaches the market.
This is what happened to pyridoxamine, a form of vitamin B6. FDA banned the supplement version because of earlier drug investigations that ended up leading nowhere.
Consumers can then be left with neither option: no supplement and no medicine. Meanwhile, the threat of exclusion gives supplement companies less reason to invest in new products that could face the same fate.
Why should an unsuccessful drug project keep an ingredient out of consumers’ hands indefinitely? As ANH and the Natural Products Association explained in a 2023 citizen petition, supplement companies may have no way to know that a drug filing already exists. They can spend years developing a product and building a business, only to learn that an earlier, unseen filing threatens their ability to sell it.
We’ve seen access to several other natural ingredients be threatened by the drug preclusion clause, including NMN, CBD, and NAC. You can read our previous coverage of those issues for more information. Fortunately, in the cases of NAC and NMN, ANH and other stakeholders successfully pushed back against bans on those ingredients.
It is high time to close this back-channel that allows Big Pharma to ransack nature to make monopoly drugs.
Tell your representative to cosponsor and support H.R. 10336. Urge your senators to advance companion legislation. Help close the back channel.
