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Explaining the FDA’s New Homeopathy Policy

Explaining the FDA’s New Homeopathy Policy
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There’s been some confusion about what the FDA’s newest attack against homeopathy means—let us untangle some of these knots. Action Alert!

Last week, we reported on the release of the FDA’s final version of a document describing how the agency will treat homeopathic medicines moving forward. The headline of that article was “FDA Declares Homeopathy Illegal.” Consumers have been justifiably outraged by this move by the FDA, but there has been some confusion about what specifically is happening.

To clarify what we said in our previous article: homeopathic medicines are not going to disappear overnight. You are still going to be able to access many homeopathic medicines. As we wrote last week, OTC homeopathic medicines for cold and flu, teething, allergies, and other less serious conditions that can resolve spontaneously with or without treatment are likely safe for the time being.

That being said, this FDA guidance is a serious threat to homeopathic medicines because it sets the stage for the agency to remove homeopathic medicines easily and with very little evidence or support. Why? Because the agency argues in the guidance that by the letter of the law, homeopathic medicines are currently being sold illegally because they have not been “generally recognized as safe and effective,” nor have they gone through FDA approval as new drugs. So, if it wants to, the FDA now has the legal authority to remove any homeopathic medicine from the market.

But, according to the guidance, the FDA is not going to do that. Instead, the agency says it will exercise “enforcement discretion” by focusing its actions on certain categories of products such as injectable products, products with safety issues, products intended for serious conditions or vulnerable populations, etc.

In theory, the FDA will turn a blind eye to many other homeopathic products that it believes are being sold illegally but do not present serious safety issues. However, the axe is dangling above these products because the FDA could, if it decided to, take enforcement action against any homeopathic products it chooses because, in the agency’s view, all homeopathic drugs are currently being marketed illegally. In the world of the FDA, a product being marketed illegally is a regulatory distinction and separate from the question of whether consumers can still purchase the product.

This is a similar situation that n-acetyl-L-cysteine (NAC) and CBD supplements face. Recall that the FDA’s position is that NAC does not meet the definition of a supplement, meaning it’s technically illegal to sell NAC supplements. The FDA didn’t actively remove NAC from the market, but its actions did have a chilling effect—Amazon, for example, voluntarily removed NAC supplements for a time.  After fierce backlash by ANH members and others, the FDA said it would exercise enforcement discretion as it decided whether to allow NAC to be sold as a supplement.  Similarly, the FDA’s current position is that CBD cannot be sold as a supplement because the agency believes it was studied as a drug first. Despite this position, the agency has allowed continued sale of many CBD supplements, choosing mostly to go after companies making illegal health claims about their CBD.

On the flip side, once the agency determines something is illegal it can choose to remove it from the market forever. This is what happened, for example, to the pyridoxamine form of vitamin B6. The FDA determined it was studied as a drug before it was sold as a supplement and banned the supplement version—no drug came to market, and it never returned as a supplement. Nicotinamide mononucleotide (NMN), a potent NAD+ booster, faces a similar threat.

It is also worth noting that the FDA is doing all of this by issuing a guidance rather than going through the public rulemaking process. On the top of every page of the guidance, and all agency guidances, you’ll see the statement, “Contains Nonbinding Recommendations.” But as we’ve argued for many years, this is far from the truth. In practice, guidances are in fact binding and must be followed—but are more difficult for the public to challenge legally.  This is a ruse by the FDA to avoid the accountability of the rulemaking process, which requires the agency to engage with the public and consider comments on its proposed rules. It is through issuing a guidance, for example, that the FDA has limited the kinds of evidence that can be used to substantiate supplement health claims.

We want to be clear. This guidance is a very serious threat, and we are doing everything in our power to stop it. But at the same time, FDA agents are not sweeping the nation’s drug stores and removing all homeopathic medicines from the shelves. We do believe that, slowly but surely, the agency will target and eliminate the homeopathic medicines that compete with FDA approved drugs because the fees companies pay for drug approval fund a substantial portion of the FDA’s operations. Homeopathic medicines are popular for allergies, for example, and this cuts into the market for drugs: the market for antihistamine nasal sprays is just under $2 billion; the market for Zyrtec, one of the most popular antihistamine drugs, was valued at $1.675 billion in 2021. Clearing the market in one fell swoop would create headlines; picking off medicines one by one over time allows the agency to accomplish the same goal without drawing as much attention or generating as much outrage.

We need to communicate to Congress that voters care about access to homeopathy and other natural medicines. A national survey found that 70% of Americans are more likely to support Congressional candidates who will protect access to supplements and homeopathic and other natural remedies.

Action Alert! Post a comment to the public docket urging continued access to homeopathic medications, and send a similar message to Congress. Please send your message immediately.

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