Bioque Technology 10/5/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
October 5, 2012
VIA CERTIFIED MAIL
200 Country Club Drive SW
Blacksburg, VA 24060
Dear Ms. Guilman:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.bioque.com in August 2012. Based on this review, your products Serum XL, Serum Rejuvenate, C-Plus Moisturizing Cream, Rejuvenating Day Cream, Rejuvenating Night Cream, Pronto, Formula 9 Firming Gel, Vitamin K1 8% Intensive Serum, Gentle Purifying Skin Cleanser, and Liposome Cellulite Therapy appear to be promoted for uses that cause these products to be drugs under sections 201(g)(1)(B) and/or section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. § 321(g)(1)(B) and § 321(g)(1)(C)]. The claims on your web site indicate that these products are drugs because they are articles 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 body of man, 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:
• “Long-term repair - 5% each of two additional peptides with anti-oxidants stimulate production of collagen and elastin… helping to repair structural damage to deeper layers of the skin.
• “Argireline provides all the muscle-relaxing properties of BOTOX®…”
• “Argireline relaxes facial muscles beneath the deepest layer of skin to reduce tightening around cavities caused by collagen and elastic deterioration, stopping the nasty process that furrows and puckers the outer layer of skin into - you guessed it -- wrinkles.”
• “Serum XL packs in …Vitamin E to heal scarring…”
• “[P]rovides the same benefits as Botox…”
• “Serum XL … repairs the structural damage that actually causes those wrinkles”
• “Wrinkle reduction—‘Signal technology’ in Intensive Penetrating Complex, a formula of active botanicals including penetrating liposomes and cell metabolism optimizers, activates production of collagen and elastane critical to rebuilding and maintaining healthy skin structure.”
• “Intensive Penetrating Complex affects its long-term repair.”
• “Damaged skin cells repair themselves and then replicate, creating healthier replacement cells.”
C-Plus Moisturizing Cream
• “Promotes collagen production…repairing existing wrinkles…”
• “[C]ounters photo-aging, protecting and repairing skin from damage from UVA and UVB rays…improve skin’s immune function and guard against free radical plaque that breaks down healthy skin structure”
• “Protection powerhouse C-Plus fends off UVA and UVB rays…and improves skin’s immune system.”
Rejuvenating Day Cream
• “Delivers a formula rich in peptides and active botanicals to fuel the rebuilding of skin structure and elasticity.”
• “With regular use and in as little as four weeks, achieve a 42% increase in skin's firmness and a 37% reduction in fine lines and wrinkles.”
Rejuvenating Night Cream
• “[F]ormula packed with peptides and active botanicals that fuel the rebuilding of skin structure”
• “With regular use and in as little as four weeks, achieve a 42% increase in skin’s firmness and a 37% reduction in wrinkles and fine lines.”
• “[H]igher concentration of beneficial elements promotes regeneration of skin cells during peak hours of sleep”
• “[P]rovides BOTOX®-like results without needles…”
• “GABA travels down nerves and blocks the signals triggering facial muscles to contract, squint, frown, pucker, furrow, feather, and crease—stopping them in their tracks.”
• “Puts wrinkles on the rocks, without the BOTOX®”
Formula 9 Firming Gel
• “Power peptides penetrate with firming and tightening gels—quickly erases lines, tightens lids, sheds sags and banishes bags.”
Vitamin K1 8% Intensive Serum
• “Count on K1 to treat it all—varicose veins, age spots … stretch marks, scars, bruises, rosacea and sun damage. Pat it on cleansed skin, and cure what ails ya!”
Gentle Purifying Skin Cleanser
• “Yucca extract frees skin of contaminants while clarifying skin, preventing acne…”
• “[I]t deposits…Vitamin C to build collagen, and Vitamin E to heal blemishes and scarring.”
Liposome Body Sculpt Anti-Cellulite Therapy
• “This gel contains ingredients that, when absorbed into fatty deposit areas beneath the skin, is designed to stimulate blood flow and cell metabolism to help your body to naturally dissolve fat deposits.”
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/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.
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 Latasha Robinson, 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