|Subject:||New Drug Application [NDA]|
|Issuer:||Center for Food Safety and Applied Nutrition|
|Issued:||Sept. 21, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740
SEP 21 2012
VIA CERTIFIED MAIL
Ian Strassler, President
Janson Beckett, Inc.
556 Route 73 South
West Berlin, NJ 08091
Dear Mr. Strassler:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.janson-beckett.com in July 2012. Based on this review, your products DermaExcel 7; AlphaDerma CE; OkuSil Intensive Eye Rejuvenating Serum with 10% Argireline; 10% Argireline & Trace Mineral Enriched Facial Skin Prep; Vitamin C&C Facial Serum; Alpha Lipoic Acid Vitamin C Ester & DMAE Moisturizing Day Cream; Alpha Lipoic Acid Vitamin C Ester & DMAE Night Cream; and BeautiFull Lips™ Lip Plumper appear to be promoted for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your web site indicate that these products are 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 observed on your web site include:
• "DermaExcel 7 is the first anti-wrinkle product to combine the three latest cutting edge peptides .... Each peptide interrupts the wrinkle producing [neurotransmitter process called the] SNARE complex differently but produces similar and collaborative results Reduced depth of wrinkles .... ".
• "Leuphasyl helps moderate the release of acetylcholine ... by lowering the skin's electrical charge in the applied area .... Leuphasyl's ability to moderate the electrical charge being sent to the applied area is crucial in lessening and relaxing muscle contraction. Impairing muscle contraction is what ... mitigates wrinkles and their formation."
• "Acetyl HexaPeptide (Argireline) ... was the first peptide to offer effects similar to BOTOX. Argireline works ... to block the nerve signals and by inhibiting the overproduction of catecholamines. By blocking these neurotransmitters, Argireline reduces the contraction of muscles and reduces wrinkles and prevents wrinkle formation."
• "HeptaPeptide (Snap-7) is a natural amino acid .... Snap-7' s advanced peptide structure is more efficient at stopping vesicle formation and neurotransmitter release than any other amino peptide. Snap-7 ... reduces deeper wrinkles .... Snap-7 accomplishes this by binding to existing Snap-25 receptors to block the release of acetylcholine. This prevents neurons from effectively transmitting signals that instruct muscles to contract. When repetitive movements are impaired, the formation of fine lines and wrinkles is reduced or prevented."
• "Because Leuphasyllowers local synaptic voltage, neuron responsiveness and efficiency is lowered. Argireline and Snap-7 then work in concert to intercept any neurotransmitters actually released. This combined method of treatment prevents and lessens muscle contractions, subsequently reducing repetitive or expressive wrinkle formation."
• "Alpha Lipoic Acid, the most potent antioxidant on the market today, helps repair aged skin while preventing future damage."
• "VITAMIN C ESTER ... boosts protective antioxidant action and helps repair past damage by aiding new collagen production."
• "[U]sing AlphaDerma CE can extend the results of a Botox injection." (from FAQs page of web site)
OkuSil Intensive Eye Rejuvenating Serum with 10% Argireline
• "OkuSil's blend of ingredients helps to stimulate the circulation in the under eye area, thus reducing or eliminating these 'Dark Circles'. Once the proper circulation has been
restored the dark circles will begin to fade along with the puffiness as they are directly related."
10% Argireline & Trace Mineral Enriched Facial Skin Prep (also referred to on your website as "Peptide Facial Skin Prep with Trace Minerals" and as "AH3 HexaPeptide Facial Skin Prep")
• "Sluggish cell energy, and thus, sluggish cellular response, can hinder peptide effectiveness. Using AH3 HexaPeptide Facial Skin Prep, under AlphaDerma CE and/or OkuSil. .. greatly improves skin response ... "
Vitamin C&C Facial Serum
• "Dual Source Vitamin C Promotes Collagen Synthesis"
• "[H]elps to protect against and repair environmental skin damage and signs of aging while stimulating collagen synthesis."
Alpha Lipoic Acid Vitamin C Ester & DMAE Moisturizing Day Cream and Alpha Lipoic
Acid Vitamin C Ester & DMAE Night Cream
• "Alpha Lipoic Acid is a recognized powerful antioxidant that repairs existing skin damage, prevents future skin damage ... "
• "Vitamin C Ester (ascorbyl palmitate) ... increases our formula's protective antioxidant action while aiding in new collagen production."
BeautiFull Lips™ Lip Plumper
• "Methyl nicitinate, a vasodilator, is used in BeautiFull Lips to plump the lips by stimulating blood flow."
• "SepiLift® counteracts wrinkled, un-toned lips by stimulating collagen production, preventing enzyme destruction ... "
Your 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 at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApprovedl/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
A venue, Silver Spring, Maryland 20993.
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 all violations associated with your products, including the violations identified in this letter. Failure to do so 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 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 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please direct your written reply to Kathleen Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition