Answer: Unproven Health Claims
Goop, a life-style branding company founded by Gwyneth Paltrow, was recently fined $145,000 by a consortium of California Counties for making exaggerated and false advertising claims about its products. The makers and distributors of everything from clothes to perfume, and face cream to condoms, Goop has a well-documented history of over-the-top marketing claims. In the action brought by the County District Attorneys, the government took exception to the claim made by Goop regarding its Jade Egg product. Goop claimed among other things that the egg product, when inserted into the vagina, prevented uterine prolapse and improved sex. In the parlance of the regulators, this was an unsubstantiated or unapproved new drug claim.
In similar fashion, cannabidiol oil or “CBD” products are at the forefront of aggressive (sometimes overly aggressive) health and medical claims. Everyone knows about “medical” marijuana, and CBD is one of several “active” ingredients found in marijuana and hemp plants which is often associated with the beneficial effects of the plant: pain relief, stress or anxiety relief, anti-nausea, and anti-inflammatory. This phenomenon has lead to a budding market in consumer products featuring CBD, accompanied by assertive health claims. The CBD market already covers a wide range of products, including cosmetics (skin creams), food products (edibles), and even CBD laced beer. To add to the confusion, a compound found in marijuana was recently approved by the FDA for treatment of a rare seizure disorder.
And this highlights the problem, especially for marketers of cosmetics. The only FDA-approved medical claim for marijuana compounds is directed to a rare seizure disorder, and this is a tiny market. To make a valid advertising claim that a skin cream product treats, for example, eczema, psoriasis or a rash, the company or brand would need to have FDA approval of the active ingredient for that particular disease or condition at issue. Absent such approval, the marketing claim would likely be regarded as an unapproved new drug and subject to regulatory fines and seizure. Thus, for example, if you want to make a skin-protectant claim for your product, you would need to use one of the FDA approved ingredients for such claims, and limit the claim to the language approved in the FDA monograph for skin protectants. To illustrate the point, witch hazel is one of the FDA approved skin protectant active ingredients. If you use witch hazel as an ingredient in your product, in the correct percentage, it would allow you to make the claim “[r]elieves minor skin irritations due to either i) insect bites, ii) minor cuts, and/or iii) minor scrapes”.
The point of all this is to make sure that your advertising claims are reviewed and approved by experienced legal counsel. This is a common area for regulatory action, as well as private class actions. The FDA routinely polices the internet looking for unsubstantiated and unapproved new drug claims. When the FDA finds a violation, it sends out a warning letter that will look something like this. You do not want to be the first one on your block to own one of these. Consult your CK&E attorney before you put a label on your product, make an advertising claim on your website, press send on an email blast promotion, or even drop a product catalog in the mail. Yes, even old school mailers can get you in trouble.
OCT
: A graphic “warning symbol” is now required on consumer products, other than food products. The “warning symbol” must be printed in a size no smaller than the height of the bolded word “WARNING,” and should be in black and yellow, but can be in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow. The entire warning must be in a type size no smaller than the largest type size used for other “consumer information” on the product, and in no case should be smaller than 6-point type.
