FDA Targets Sulbutiamine and Nootropic Supplements

The FDA increased enforcement against supplements containing sulbutiamine and similar synthetic nootropic compounds in early 2025. This continues a pattern of targeting ingredients that regulators consider pharmaceutical rather than dietary supplement ingredients.

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Dual Problem: Warning letters cited two main concerns—the ingredient's regulatory status AND the cognitive enhancement claims made for products containing it. Both issues need to be addressed.

What Triggered Enforcement

Sulbutiamine is a synthetic derivative of thiamine (Vitamin B1) that's been marketed in nootropic supplements for cognitive enhancement. The FDA's position is that synthetic derivatives of vitamins don't automatically qualify as dietary ingredients, especially when they're marketed for drug-like effects.

The Ingredient Status Problem

Under DSHEA, dietary supplements can contain vitamins, minerals, herbs, amino acids, and other dietary substances. The FDA interprets this narrowly for synthetic compounds.

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Key Issue: A synthetic derivative of a vitamin isn't automatically a vitamin. Sulbutiamine exists as a pharmaceutical in some countries, which strengthens the FDA's argument that it's a drug ingredient being sold as a supplement.

This logic applies beyond sulbutiamine. Other synthetic nootropic compounds face similar regulatory questions. Brands selling any synthetic cognitive enhancement ingredient should review their formulation's legal status.

The Marketing Claims Problem

Even if an ingredient were acceptable, the claims matter. Nootropic supplements often make cognitive enhancement claims—improved focus, better memory, enhanced mental clarity—that approach drug claim territory.

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The Line: "Supports brain health" might be acceptable. "Enhances cognitive performance" starts to sound like a drug claim. Products combining questionable ingredients with aggressive claims become easy enforcement targets.

Impact on Advertising

Advertising platforms follow FDA enforcement. When the FDA sends warning letters, Meta and Google often restrict the affected brands and sometimes the entire product category.

Nootropic advertising already faces challenges on major platforms. Additional FDA enforcement makes approval harder for all products in the category, not just those specifically targeted.

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Ripple Effect: If you're advertising nootropic products, expect increased scrutiny of both your ingredients and your claims—even if you weren't directly targeted by FDA action.

Reviewing Your Products

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Formulation Audit:

Check for synthetic nootropic compounds in your products
Flag ingredients that are pharmaceuticals in other countries
Review cognitive enhancement claims for drug-like language
Consider reformulating to use ingredients with clearer regulatory status

Traditional nootropic herbs with long histories of dietary use face less regulatory risk than synthetic compounds.

The Broader Nootropics Question

This enforcement fits a larger pattern of FDA skepticism toward nootropic products. The category grew faster than regulatory frameworks could adapt, and supplements with drug-like positioning are now facing corrections.

Brands that positioned nootropics as cognitive drugs now need to either reformulate and reposition, or accept that advertising will become increasingly difficult.

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Path Forward: The survivors in this category will be brands that use well-established ingredients and make conservative claims. Premium positioning based on ingredient quality rather than dramatic efficacy claims offers a sustainable path forward.