Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
NOV 24, 2014
VIA OVERNIGHT DELIVERY
Irene Hardy, Owner
5251 California Ave.
Irvine, CA 92617-3074
Dear Ms. Hardy:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet addresses 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.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
On the website www.cellvitals.com, under the “Skincare Tab,” and under:
Reluma Advanced Stem Cell Facial Moisturizer:
- “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.”
ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser:
- 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).
ReLuma Stem Cell Eye Cream:
- “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.”
Your “Reluma Advanced Stem Cell Facial Moisturizer,” “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser,” 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).
A description of the new drug approval process can be found on FDA's internet website http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. 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.
Furthermore, your “Reluma Advanced Stem Cell Facial Moisturizer” and “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser” 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)].
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
We request that you take prompt action to correct the violations associated with your products. Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. 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.
Please submit your response to Ms. Dehlia Young, Compliance Officer, Labeling and Dietary Supplement Compliance Branch (HFS-608), Division of Enforcement, Office of Compliance, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions, please contact Ms. Young at (240) 402-5163 or email@example.com.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition