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Seller Beware of Product Claims

Posted by on May 18, 2010 · 12 Comments 

Don’t be tempted to make OTC claims on your cosmetics.  My inbox has been full lately of miracle cures, blends, and products that will keep me safe from H1N1, colds and all the other flu bugs out there.  Even if your essential oil blend or herbal extract is the next great cure for all that ails us DO NOT make any claims, don’t imply it and don’t use product testimony to do so either.

There is a clear distinction between cosmetics and over-the-counter drugs (OTC) that is not meant to be blurred.  The FDA and the FTC sent Dr. Weil a warning letter this week regarding his product claims for “Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus”

The warning letter states, “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.”

It goes on to say, “In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.”

I recently got an email from an essential oil supplier (not one of mine) stating, “Can a fragrance actually be considered healthy and holistic? Absolutely! The H1N1 virus has all of us concerned and many of our customers have come to us asking if we have any fragrance blends that have anti-bacterial properties. Well, we do!…This broad description of ANTISEPSIS includes anti viral, antifungal, anti-bacterial and general anti-microbial activity which is found in such oils as: Lemon, Thyme, Tea Tree, Garlic, Eucalyptus, Cinnamon, Pine, Lavender and Sandalwood…”  Any company that uses this claim on their website, marketing or advertising can expect a similar letter from the FDA and FTC.

Dr. Weil has issued a response to the warning letter that you can read here.  I commend Dr. Weil for this statement, “All Weil editorial content is reviewed for compliance with FDA /FTC guidelines. I directed the website team to remove the FDA/FTC-referenced content for review, and they have done so. I fully support the FDA/FTC task force in its efforts.”  We all should be following his lead and checking all of our marketing material to insure that we are not crossing the line either.

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More about the author:  Kayla Fioravanti is the Vice President, Chief Formulator, ARC Registered & Certified Aromatherapist for Essential Wholesale and its lab division Essential Labs. Read more from this author

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  • http://www.sterlingminerals.com/ Katherine@sterlingminerals

    The FDA is certainly a confusing entity with its rules and regs. I just got off the phone this morning with the FDA Cosmetics and Colorants division and they stated to me that even if you don't have the claims on the label that a separate ingredient glossary where many cosmetic companies, including my own, describe the reputed benefits of a certain ingredient, is considered by the FDA to not be allowable even though it is excluded from the packaging and main product description.

    In regard to customer testimonials, they stated to me that these are allowed and there are no restrictions in regards to publishing customer testimonials on the website or other literature. So a customer can make a belief or claim of our products but we can't.

    Is anyone else confused? The FDA in my opinion makes it extremely difficult to disseminate their information and is it based on whom you speak to that day? Because in the past I was told that ingredient glossaries only are allowed for description of an ingredients benefits separate from product displays and main commerce.

    I believe crack downs are more regulated and enforced in terms of dealing with vitamins and supplements and why Dr. Weil was warned, and why we are seeing the FDA be very stringent in this regard, but in terms of cosmetics it is not something they regularly pursue.

    Clarification to say the least is needed and therefore the question needs to be asked “how do we achieve total compliance when the FDA, consumer, or cosmetic manufacturer all have different interpretations which are not necessarily easily clarified through the FDA themselves?”

  • annwooledge

    Thanks Kayla – I've seen this before and at that time we began to take a closer look at what we do actually say on our website. We've been in the middle of switching to a new website now for almost a year, some of which was taken from the old site, some from copywriters (who probably don't understand or even know all this) and some from the my updates. My job is to now check every description and make sure we're following your clearly stated guidelines.

    HOWEVER, in the middle of all this I read a post from another company's blog about ingredients that she felt were not safe. I then noticed that her products are USDA certified organic, but the name of her face cream for men and women is “Anti-aging Women's Cream”! The product itself was just a very simple waterless blend that hobbyist could and do easily make, but my point is – how could it go through the certification process and still get by with that label? From everything I've read we can't make those claims – much less name our products that. Thanks Katherine for the information you just posted. I was reading one of the major women's magazines – actually going through several the other day while sitting at Barnes & Noble trying to accumulate good key words to use in our descriptions. I was appalled and amazed that ALL (I did say ALL) the large manufacturers of cosmetics are making these anti-aging, anti-wrinkle, miracle this and miracle that claims all over the place in two-page ads. But, we as small manufacturers can't? Confused is an understatement.

  • SUSAN

    Great Article Kayla! I was writing something similar for my blog last night. What some companies don't realize is, there ARE plenty of OTC drug/cosmetics on the market who are legally following the OTC drug labeling laws. It's not illegal to sell OTC drugs…you just have to follow the law. The law being broken a lot heading into summer is making SPF claims on a cosmetic…that makes the product an OTC drug. You don't have to be claiming to cure H1N1 to be breaking the law. I'm working on a sample list of illegal claims. I've reported two companies to the FDA in the past month, both were making illegal OTC drug claims and both are using illegal colorants. While anyone can make and sell cosmetics, thinking your product actually performs medicinally without any proper drug testing, is really pretty arrogant, beyond being illegal. 90% of the cosmetics out there don't even perform the cosmetic claims made for them…much less the drug claims! Thanks for putting the situation into perspective.

    • SUSAN

      I was going to add this information to my blog but this seems to be an even better place to address this important subject. I looked at a few websites today and saw this violation all over the place! “…”anti aging” claims which cause the products to be unapproved new drugs.” This is not a grey area…it’s outlined clearly in “Import Alert # 66-38; Published Date: 04/01/2010″ http://www.accessdata.fda.gov/cms_ia/importalert_188.html

    • Capassoshannon

       so where do we find these laws?

      • http://twitter.com/SueApitoLikes Sue Sawhill Apito

        Hey Shannon – this is Susan.  All the laws are on the FDA website.

  • http://twitter.com/essentialU Kayla Fioravanti

    Excellent points everyone. In regards to the USDA certified cream — well if it it really is a cream then it can't be USDA certified organic. Are there any emulsifying ingredients? If so it would be disqualified as certified organic. Are there any synthetic preservatives? Again disqualified. Unless that cream is actually just oil and water with maybe some beeswax it isn't really USDA organic certified. But if it really is a cream and meets the certified organic standards than no they don't check claims. It is all about processes and ingredients and a very long trail of paperwork.

  • SUSAN

    “Excellent points everyone. In regards to the USDA certified cream — well if it it really is a cream then it can't be USDA certified organic. Are there any emulsifying ingredients? If so it would be disqualified as certified organic.” I must disagree. I know of USDA certified organic creams. And since there are natural emulsifying ingredients I'm not sure why this would violate NOP laws. Here is an article worth reading – very balanced: http://www.specialchem4cosmetics.com/community-…

  • http://www.laviecelesteskincare.com Teri Dourmashkin

    Great post. I hired a lawyer familar with FTC guidelines to go over all of my product packaging before I printed my labels and boxes. It is amazing what you CAN and CANNOT say. It amazes me how many companies are violating the rules. For example, you cannot refer to a natural botanical as having “anti-inflammatory” properties. Yet, I see this done all of the time. You cannot even use the word “anti-aging.” And yes, getting into OTC claims is a whole other ball game indeed. Thanks!

  • SUSAN

    “It amazes me how many companies are violating the rules. For example, you cannot refer to a natural botanical as having “anti-inflammatory” properties. Yet, I see this done all of the time. You cannot even use the word “anti-aging.” “

    YES!! It is pretty shocking how many companies…even those owned by people others look to for advice…are violating the laws regarding the OTC Drug Claims on their product labels. The law is clear…and testimonials are considered “claims” so thinking that technique of getting someone else to say it and thinking that gives you a free pass is just as illegal.

  • http://www.sterlingminerals.com/ Katherine

    This piggy backs to my initial comment about the ambiguity of the FDA and how their guidelines and regulations are extremely vague and can clearly cause confusion for many personal care product manufacturers, large and small. In an attempt to remain vague they have allowed themselves a way to change the rules whenever it serves a specific purpose or agenda at the time.

    An example of where this is occurring is within the health food and health supplement industries. Walnuts and cherries were recently targeted as to them being misbranded when sound scientific evidence has shown their antioxidant qualities, heart healthy and cholesterol reducing capabilities and similarly are great for prevention of cancer.

    Basically what the Alliance for Natural Health has been shouting from the rooftops about censorship by the FDA. Big pharma is being hurt by the natural care industry as are skin care drug companies with their healing acne and other ailments of the skin when certain ingredients more natural and with fewer side effects are also within a similar category of being censored. I am in complete support of what ANH is doing since it affects all of us including those that use organics for what they can offer in a particular scientific study showing individual ingredients can have an improvement in certain skin conditions. Not to confuse a claim on the actual product but when ingredients are reputed for certain benefits with the data to back it up as in the case of vitamins and natural foods. The first article shows what happened to Diamond foods while Frito Lay, essentially a junk food is allowed to continue to make inflated claims without retribution. So, ANH sued the FDA and defeated them over this censorship ruling which is the second article attached.

    http://www.anh-usa.org/tell-the-fda-that-cherri…

    http://www.anh-usa.org/court-finds-for-anh-usa-…

    It is a precedent setting win for the natural health industry and we'll see how it fairs. Due to this latest article I decided to speak with the FDA today citing this article and the recent court ruling, although individual product claims cannot be made without the proper testing especially at the location of where the products are sold, we are not prevented from writing articles on an individual ingredient which has been found to have benefits to our overall health including skin health. Since it would clearly fall on censorship in terms of journalism and our opinions in review of the subject matter.

  • http://www.sterlingminerals.com/ Katherine

    This piggy backs to my initial comment about the ambiguity of the FDA and how their guidelines and regulations are extremely vague and can clearly cause confusion for many personal care product manufacturers, large and small. In an attempt to remain vague they have allowed themselves a way to change the rules whenever it serves a specific purpose or agenda at the time.

    An example of where this is occurring is within the health food and health supplement industries. Walnuts and cherries were recently targeted as to them being misbranded when sound scientific evidence has shown their antioxidant qualities, heart healthy and cholesterol reducing capabilities and similarly are great for prevention of cancer.

    Basically what the Alliance for Natural Health has been shouting from the rooftops about censorship by the FDA as reflected in the first article. Big pharma is being hurt by the natural care industry as are skin care drug companies with their healing acne and other ailments of the skin, when certain ingredients more natural and with fewer side effects are also within a similar category of being censored.

    I am in complete support of what ANH is doing since it affects all of us including those that use organics for what they can offer in a particular scientific study showing individual ingredients can have an improvement in certain skin conditions. Not to confuse a claim on the actual product, but when ingredients are reputed for certain benefits with the data to back it up as in the case of vitamins and natural foods. The first article shows what happened to Diamond foods while Frito Lay, essentially a junk food is allowed to continue to make inflated claims without retribution. So, ANH sued the FDA and defeated them over another censorship ruling which is the second article attached. But it will certainly open the door to others to take a stand if they have the data to back up their health claims.

    http://www.anh-usa.org/tell-the-fda-that-cherri…

    http://www.anh-usa.org/court-finds-for-anh-usa-…

    It is a precedent setting win for the natural health industry and we'll see how it fairs in regard to other aspects of keeping us healthy including ingredients we use on our skin. Due to this latest article I decided to speak with the FDA today citing this article and the recent court ruling, although individual product claims cannot be made without the proper testing especially at the location of where the products are sold, we are not prevented from writing articles on an individual ingredient which has been found to have benefits to our overall health including skin health. Since it would clearly fall on censorship in terms of journalism and our opinions in review of the subject matter.