Looking for Product Drug Claims

When we talk about “drug claims” we are actually talking about the statements that tell the consumer that product is intended to be used to diagnose, mitigate, treat or prevent disease or to change the structure or function of the body. How does the FDA determine the intended use of a product? Where do they look?

Recent Warning Letter

Sometimes examples are a good way to understand how laws and regulations are applied in reality.  It helps to see examples where the FDA said, “There!  That’s a statement that makes this product an unapproved new drug.”  Those examples are in warning letters that the FDA sends out.

The FDA just published a warning letter that was sent in May to a company in Georgia. They make cosmetics and nutritional supplements containing silver.

Where did the FDA look?

What was particularly interesting about this warning letter was where the FDA looked for the statements to determine the intended use of the product (as a drug).  In the past, I have seen the FDA cite product labels, website meta-tags and sometimes testimonial pages.

This is the first time I have seen the FDA cite so many different places, including:

  • Product NAME (“Hand Sanitizer” )
  • Product labels
  • General from website
  • Testimonials page of website (quoting customer testimonials)
  • Research page of website (research information and studies)
  • History page of website (uses across the globe)
  • Usages page of website
  • Promotional card
  • Promotional brochure

What did they find?

The FDA found numerous examples of claims that made the products into unapproved new drugs.  That is, the products were intended to be used to diagnose, mitigate, treat or prevent disease or to change the structure or function of the body — and they weren’t approved for such uses.

Some of the claims they found made for the body care products included:

  • Anti-bacterial and anti-microbial
  • Sanitizes
  • Product name “Hand Sanitizer”
  • Natural Antiseptic
  • Anti-cavity
  • Anti-gingivitis
  • Anti-plaque
  • Reduces tartar buildup
  • Soothes toothaches, irritated gums, inflammation
  • Helps to reduce inflammation and minimize breakouts
  • Beneficial for acne, cuts, burns & rashes
  • Rebuild damaged tissue
  • Stimulate production of stem cells
  • Protects from bacteria and infection
  • Used to aid wound healing

It’s pretty clear that these product are intended to do much more than cleanse or improve the appearance.

What can you learn?

There are several take-aways from reviewing this warning letter:

  1. Don’t say that your product can diagnose, mitigate, treat or prevent disease or change the structure or function of the body.
  2. Remember that the FDA looks at more than just the product label.
  3. Review the text all through your website to ensure you haven’t made any statements that cause your products to become unapproved new drugs.
  4. Monitor the testimonials you allow to be published.
  5. Don’t quote studies that state your product or ingredients have the ability to diagnose, mitigate, treat or prevent disease or to change the structure or function of the body.


Additional Note

This warning letter covers both cosmetics and products intended to be ingested as nutritional supplements.  Nutritional supplements are covered by different regulations than cosmetics.  Some claims are allowed for nutritional supplements that are NOT allowed for cosmetics.  This warning letter also cites the company for not following good manufacturing practices for their nutritional supplements, which are required in the regulations.  If you read the actual warning letter, don’t get confused about what applies to cosmetics and what applies to nutritional supplements.

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10 responses to “Looking for Product Drug Claims”

  1. Jen k

    Hi Marie, If using a premade liquid hand sanitizer base of 80% alcohol with a small amount of added fragrance oil, would one be able to label and sell small bottles as simply a “hand cleanser” without making actual antibacterial claims or calling it “sanitizer”?

    1. Marie Gale

      So long as you don’t claim that it is anti-bacterial or a hand sanitizer, it’s not a drug. “Hand cleanser” just implies that it cleans.

      Make sure that the LABEL doesn’t include any “drug facts” or “active ingredients.”

  2. Erin Shelly

    All the information you provide is extremely useful, thank you for your time and expertise. I’ve put extended hours over the course of many days into comprehending the range of possible violations to the drug claims in cosmetics regulations. I realize that is some cases the line is vague. One thing I’ve seen a lot of but no matter how much time I spend researching I cannot find the answer to: whether claims of “balancing” and “clarifying” to the skin fall into the category of drug claims (to me they would because they imply that the skin itself is imbalanced or gross/contaminated, especially and often appearing with additional claims of “removing impurities”, sometimes by their “deeply penetrating” action…). As I understand it, claims to “detox” or similar statements are a violation, as is effecting “even skin tone” (if, for instance, the claim of balancing is meant to refer to color as opposed to state), so it seems in every conceivable case that these two terms should be on the no-no list.

    1. Marie Gale

      In cases like these, it’s not so much the individual words, but the overall idea that the consumer gets after looking at all of the material available about the intended use of the product. “Detox” is generally altering function or structure. “Balancing” could mean making the red areas or freckles blend in (as with a foundation) or actually changing the skin tone; one is cosmetic, one is not. “Balancing” could also mean evening out the oiliness: with a toner or something to remove excess oil it’s a cosmetic; if it changes the oil production, it’s a drug. “Even skin tone” is similar. But with any of them, as soon as you talk about “removing impurities” (other than just cleansing) or mention acne, red spots, blackheads, etc,, you’re likely into the drug category.

      So there is no list of words that always work. It’s a matter of how the words are combined and what else might be in the labeling.

      1. Erin Shelly

        Thank you so much for your take on the matter. While much of the explicit details are quite clear, it’s been extremely frustrating to navigate all the vagaries, open-endedness, and subjectivity nonetheless surrounding this subject–your assessment makes sense and is about as clarified (haha) as I expect it to get!

  3. Maralee

    Just found your site and it’s amazing! I have your books and they are wonderful too but the added examples here answer those little niggling questions that seem yo pop up. In fact I have another one. I read about a woman who was inspected and asked to install caged lights in her soap making area. If I make soap in my kitchen, do I have to have caged lights? Will any unbreakable cover over the lightbulb do or does it have to be a commercial metal cage?

    1. Marie Gale

      There are no exact specifications in the guidelines or the regulations. The final determination would be based on an inspection and up to the individual inspector. The GENERAL rule is that you should ensure that there is no way that overhead lights could contaiminate your product (that’s the bottom line).

      So things like ensuring that if a fly hit the light and was burned to death, it wouldn’t fall into your lotion, or if a spatter got loose (or something else happened) and a light was broken, it wouldn’t contaminate your product. Covered lights would probably be sufficient; generally household/kitchen lighting is likely to be okay.

  4. Carol

    Most comprehensive information I have found.

  5. Mrs. Marie!! How are you? Thank you so much for keeping us informed so that we can be FDA compliant. I recently met you at the HSCG soapers conference in Atlanta and I took your labeling class. You are loved and respected. Thx agai!!

    1. Marie Gale

      Thank you!

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