Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|College Park, MD 20740|
es www.cellvitals.com in September 2014. Based on this review, your products “ReLuma Advanced Stem Cell Facial Moisturizer,” “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser,” and “ReLuma Stem Cell Eye Cream” appear to be promoted for uses that cause these 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 Act) [21 U.S.C. § 321(g)(1)(B) and § 321(g)(1)(C)]. The claims on your website indicate that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act.
- “Human Adipose Derived Stem Cell Conditioned Media [an ingredient in your product]-…With TGF-b (transforming growth factor-beta) to stimulate fibroblast cell growth, in the presence of PDGF (platelet derived growth factor) and …it increases collagen, elastin, and other matrix protein production…”
- “Camellia Sinesis Extract [an ingredient in your product]…is anti-bacterial and … anti-cancer.”
- “Tetrahexyldecyl Ascorbate [an ingredient in your product] – Vitamin C oily(an antioxidant) increases collagen levels, reduce [sic] melanin production… and repair the effects of UV exposure…”
- “Acetyl Hexapeptide-8 [an ingredient in your product] – Argireline® …keeps down the release of a neural signal protein (catecholamine) and thus, prevents the muscle contraction involved in facial expressions.”
- “Leuphasyl® (Pentapeptide-18) [an ingredient in your product] -…couples to the enkephali receptor, outside of nerve cells which in turn close calcium channels and consequently inhibiting [sic] acetylcholine release and attenuate muscle contraction and reduce expression line wrinkles.”
- Calendula Extract [an ingredient in your product] -Anti-inflammatory/itching herb, assists in strengthening capillaries, anti-inflammatory/itching [sic], helps heal, contains L-Beta-Sitosterol (anti-inflammatory and anti-cancer); D-Lupeol (anti-peroxidant and anti-inflammatory); and L-Rutin (anti-capillary-fragility factor).
- “Human Adipose Derived Stem Cell Conditioned Media: [an ingredient in your product]…activation of collagen synthesis.”
- “Tetrahexyldecyl Ascorbate: [an ingredient in your product] …protect cells from …inflammation.”
- “Roxisomes: [an ingredient in your product] React like liposomes [sic] and helps [sic] repair DNA damage by UVA in sunlight.”
and “ReLuma Stem Cell Eye Cream” products are not generally recognized among qualified experts as safe and effective for the above-referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)] a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA).
. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
This page was posted on March 16, 2019.