Your Website Is an FDA Compliance Issue

For many consumer brands, the package receives careful legal review while the website is treated as “marketing.”

From an FDA perspective, that distinction can be dangerous.

FDA evaluates representations made about regulated products when determining issues such as intended use, product classification, labeling, and whether a product is being marketed in violation of the FD&C Act.

FDA’s online advisory-letter program demonstrates that website claims can independently become the subject of FDA action. The agency currently publishes online advisory letters concerning websites marketing products for the treatment or prevention of serious diseases.

Your Website Is Part of the Regulatory Picture

A consumer may see a product page as advertising.

A regulator may see it as evidence of what the company intends the product to do.

That distinction is particularly important for products that exist near the boundary between:

• Food and drug;
• Cosmetic and drug;
• Dietary supplement and drug; or
• General wellness product and disease-treatment product.

Under the FD&C Act, intended use is central to determining whether a product falls within the definition of a drug.

Claims Can Change Regulatory Classification

Consider the difference between:

“Supports healthy skin”

and:

“Treats eczema.”

The second statement communicates a disease-related therapeutic purpose.

Likewise, a conventional food marketed simply as a food may raise a very different regulatory analysis if the company’s website represents that it treats diabetes, prevents cancer, or replaces a prescription therapy.

The exact legal analysis depends on the product and the claim, but the underlying principle is important:

Marketing can affect regulatory classification.

Disease Claims Are Particularly High Risk

FDA’s current online advisory-letter program focuses specifically on websites promoting products for serious diseases. FDA states that such websites can mislead consumers into believing products are safe and effective to treat or prevent serious diseases.

FDA’s 2026 online advisory-letter database includes products marketed in connection with serious diseases and conditions, including cancer, diabetes, viral infections, and other medical conditions.

Companies operating in supplements, wellness, beauty, functional foods, and related categories should therefore be particularly careful with disease-adjacent claims.

Testimonials Can Be Problematic

One of the most overlooked areas is the testimonial.

A company may carefully review its official copy while overlooking statements made by:

• Customers;
• Influencers;
• Affiliates;
• Brand ambassadors;
• Healthcare professionals;
• Retail partners.

A testimonial stating that a product “cured my diabetes,” for example, raises a very different regulatory concern than a testimonial describing taste or personal experience.

Companies should have procedures governing what claims may be solicited, reposted, amplified, or incorporated into advertising.

The Website Audit

A meaningful FDA website audit should examine more than the product description.

Review:

Homepage
What overall impression does the company create about the product?

Product pages
What benefits are promised?

Testimonials
Are consumers making disease-related or therapeutic statements?

Blog
Do educational articles establish an unintended intended use?

FAQs
Could a seemingly simple answer communicate a drug claim?

Before-and-after photographs
Could the visual presentation communicate a therapeutic purpose?

Social media
Are official accounts making stronger claims than the website?

Influencer campaigns
Are influencers being provided appropriate claims guidance?

Retailer listings
Are Amazon, Target, Walmart, or other third-party descriptions consistent with approved claims?

Why Periodic Audits Matter

Claims evolve.

A product may launch with conservative language and later accumulate dozens of statements across social media, influencer campaigns, customer testimonials, and digital advertising.

The regulatory risk therefore increases over time unless someone is actively managing it.

A strong claims-compliance program should include:

Pre-publication review + approved claims library + influencer guidance + periodic audits + escalation procedures.

The Bottom Line

For an FDA-regulated product, the website is not merely a sales tool.

It can become part of the evidence FDA considers when evaluating what the product is intended to do and how it is being marketed.

Companies should therefore review digital marketing with the same regulatory discipline applied to packaging.

Garg Law helps consumer brands conduct FDA claims reviews and develop compliant marketing strategies across websites, advertising, social media, influencer campaigns, and retail platforms. Please contact info@garg-law.com for support on website and marketing reviews, and other questions on FDA compliance and enforcement.