The letter reveals the FDA to have reviewed the company’s websites and determined that ‘Aloe Milk Moisturizing’, ‘Aloe Moisture Cream’, ‘Day-Night Emollients’, ‘Moisturizing Aloe Lotion’ and ‘Aloe Comfrey Gel’ amongst other items, were being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act.
“The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.”
The complaint
The FDA goes on to list specific areas that it has a problem with, highlighting the description of ingredients in products as the main culprit to have violated the aforementioned Act.
It guides the company's managing director to a description of Apricot kernel oil in the brand’s ‘Day-Night Emollient’ quoted as being a “natural source of cancer fighting laetryl lipids.”
While also highlighting another description of safflower and avocado oils in a ‘Moisturizing Aloe Lotion’ as "helping to renew skin flexibility by making regeneration of skin cells occur faster.”
In addition, the administration had a problem with multiple claims appearing on the site intending the aloe vera products for use as drugs.
A page entitled ‘pharmacological activities of aloe vera gel’ was given as an example where it describes some of the products as “relieving pain deep beneath the surface including pain associated with joints and sore muscles” and having “similar anti-inflammatory properties similar to that of a steroid.”
Ruling
Thus the FDA concluded that the products were not generally recognized as safe and effective for the above referenced uses and therefore, the products are ‘new drugs’ under section 201(p) of the Act [21 U.S.C. § 321(p)].
"Furthermore, because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses."
Thus, these products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these products fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].
Advice
Finally the letter advised the company's CEO "to review your websites, product labels, and other labeling and promotional materials for all your products to ensure that the claims you make for your products do not cause them to violate the Act."
Failure to implement lasting corrective action of violations may result in regulatory action being initiated by the FDA without further notice.
Cosmetics Design approached Set-N-Me-Free Aloe Vera representatives but found they were unavailable for comment at the time of publication.