Department of Health and Human Services
Public Health Service
1 Montvale Ave
Juiy 27, 1999
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Gregory Kelley, President
107 Oakwood Dr
Glastonbury, CT 06033
Ref. No. NWE-27-99
Dear Dear Mr Kelley:
This letter is in reference to the distribution, promotion, and marketing of "Shen Min Activator with Minoxidil" and "Shen Min Topical" Solution by your firm. During an inspection of your facility located at the above address on May 25, 1999, our investigator determined that you are responsible for the development of the product formulations, designing of labeling and promotional material, and distribution for these products.
According to the label, "Shen Min Activator with Minoxidil" contains, among other ingredients, minoxidil, retinyl palmitate, saw palmetto, biotin, panthenol, tocopherol acetate, trichopeptide, he shou wu, and jojoba oil. The labeling, including promotional material, contains the following statements such as "Minoxidil is well known as one of the most successful topical serums available today, " "Retinyl Palmitate is scientifically proven and patented to stimulate follicular embryonic activity," "DIRECTIONS FOR USE: Apply 15-20 drops directly onto the scalp as needed in the hair loss area," and "Shen Min Activator with Minoxidil features our proprietary Bio-Vector Lipid Complex delivery system … It is controlled-release to ensure continuous stimulation of the follicles."
A "technical sheet" for "Shen Min Activator with Minoxidii" contains statements such as "To … enhance hair growth," and "Shen Min, Activator is a revolutionary blend of natural nutrceutical [sic] components plus minoxidil the well known hair growth serum."
According to the label, "Shen Min Topical" Solution contains "powerful nutrients time-released directly onto the scalp. " The labeling for the product contains statements such as "FOR THINNING HAIR, and "…assist in stimulating embryonic follicle metabolism.…" A "technical sheet" of "Shen Min Topical" Solution contains statements such as"…helps to enhance hair growth…" and "It is designed to treat the effects of Alopecia…"
Based on the intended uses described above, "Shen Min Activator with Minoxidil" and "Shen Min Topical" Solution are drugs (section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act)) and are subject to the final rule cowring Hair Grower and Hair Loss Prevention Drug Products for Over-the-Counter Human Use (Title 21 Code of Federal Regulations (21 CFR) Part 310.527). Under that rule, no active ingredients are generally recognized as safe and effective to grow hair or prevent hair loss. Therefore, "Shen Min Activator with Minoxidii" and "Shen Min Topical" Solution are "new drugs" (section 201(p) of the Act). A "new drug" may not be marketed in the United States without an approved new drug application (NDA) (section 505(a) of the Act). In addition, these products are also misbranded (section 502(f)(1) of the Act), because they do not bear adequate directions for the indication noted above.
Further, "Shen Min Activator with Minoxidil" and "Shen Min Topical" Solution are misbranded (section 502(o) of the Act) because they have not been drug listed as required (section 510(j) of the Act).
The violations cited in this letter are not intended to bean all-inclusive statement of all the violations that may exist for products marketed by your firm. It is your responsibility to assure that all your drug products are in compliance with federal laws and regulations. Federal agencies are advised on the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include a seizure and/or an injunction.
We have reviewed the letters dated June 16, 1999, and June 21, 1999, prepared by your attorneys, that you provided to our investigator. Upon review and as stated earlier in this warning letter, the United States Food and Drug Administration has determined that the "Shen Min Activator with Minoxidil" and "Shen Min Topical" Solution are, based on their intended uses, drug products as defined at section 201(g) of the Act. Further, they are new drugs as defined at section 201(p) of the Act and they are misbranded.
Therefore, within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps you will take to correct the noted violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and time frame within which corrections will be completed. Your reply should be sent to Mr David K. Elder, Compliance Officer, at the address noted above. If you have any questions concerning this matter, please contact Mr Elder at 781-279- 1675, extension 125.
John R. Marzilli
This page was posted on August 20, 2006.