|Company:||Libido Edge Labs, Llc|
|Subject:||Unapproved New Drug Promotional Claims/Misbranded|
|Issuer:||Cincinnati District Office|
|Issued:||June 10, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
June 10, 2010
WARNING LETTER CIN-10-94106-12
Ms. Ruth M. Moran
Libido Edge Labs, LLC
26 E. Stevens Street
Newark, OH 43055
Dear Ms. Moran:
This letter is in reference to your firm's marketing and distribution of "Natural Progesterone Cream USP with Adrenal Support," "Testosterone Cream Formula FOR WOMEN," "Testosterone Cream Formula FOR MEN," "Total HGH Cream," and "LibidoEdge Capsules NATURAL SEXUAL ENHANCEMENT," on your website http://www.libidoedgelabs.com.This website, which constitutes labeling for these products, contains therapeutic claims that cause the products to be drugs, as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), (21 U.S.C. § 321(g)), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body of man.
Objectionable claims and the products for which these claims are being made, as well as statements of ingredients, include, but are not limited to, the following:
Natural Progesterone Cream USP with Adrenal Support
: Micronized Natural Progesterone USP, Vitamin C & E, Chaste Tree Berry, Squaw Vine, Cramp Bark, Red Raspberry Leaf, Blue Vervain, Mugwort leaf, Dandelion Root & Leaf, Usnea Lichen, Prickly Ash Bark, Rose hips, Syrup of Sweet Grapes, Seaweed
• "Additional Ingredients: Purified Water, Vegetable Oil Blend, Sepigel 305, Laureth-7, Aloe Vera, Sorbic Acid, Potassium Sorbate, Grain Alcohol, Vegetable Glycerin ...."
• "Progesterone Cream with Adrenal Support keeps adrenal glands functioning optimally thus improving bone density, keeping bad cholesterol levels under control, provides energy and improves mental sharpness and clarity ...."
• "Progesterone Benefits Include: Relief from PMS Symptoms ... Relief from Menstrual Cramps ... Adrenal Gland Support Restores the Sex Drive ... Relief from the Normal Symptoms of Menopause ... Weight Loss ... Natural Antidepressant ... Offers Relief from Migraine Headaches ...."
Testosterone Cream Formula FOR WOMEN
• " Active ingredients: Homeopathic Testosterone, Homepathic [sic] Human Growth Factor, Homeopathic IGF-1, Dehydroepiandrosterone (DHEA), Ginko [sic] biloba extract, Damiana, Horny goat weed extract, Mucuna Pruriens extract, Tribulus terrestris extract, Gama aminobutyric acid (GABA), Chrysin, Diindolylmethane (DIM) ...."
: Purified water, Safflower oil, Aloe Vera, Evening Primrose oil, Hemp seed oil, Organic grain alcohol, Lecithin, Vitamin E oil, Sepigel 305, Mandarin Red Oil, Potassium sorbate, Sorbic acid ...."
• "Evidence is accumulating that for women, testosterone is important for : . .. .. maintaining lean muscle mass ..... bone density ..... increasing libido and sex drive ... • sustain energy ... .. prevent depression . .. • relief from pain and stiffness in muscles and joints ... • decreased body fat ... • improved sleep quality ... • maintaining the health and sensitivity of the vaginal tissues. (Women need about one tenth of the circulating testosterone that men do.) ...."
• "TIME RELEASED" LIPOSOME DELIVERY ...."
• "Libido Edge Testosterone for Women is a potent synergistic formula that combines natural Homeopathy with safe powerful herbal extracts to provide you with a highly effective product .."
• "Many women do not realize that low testosterone levels result in low libido and loss of energy, flabby skin, and fat deposits . With daily use of Libido Edge Testosterone Cream Formula for Women, these level [sic] can be restored without the negative and unwanted side effects."
Testosterone Cream Formula FOR MEN
• "Active ingredients: Homeopathic Testosterone, Homepathic Human Growth Factor, & IGF-1, DHEA, Chrysin, GABA acid (gama aminobutyric acid), Diidolymethane, herbal extracts of Horny goat weed, Mucuna Pruriens Tribulus terrestris, Ginko [sic] Biloba ..."
. • "Other ingredients: Purified water, Safflower oil, Aloe Vera, Organic Grain alcohol, Sepigel 305, Evening Primrose oil, Hemp seed oil, Lecithin, Vitamin E oil, Mandarin Red oil, Potassium sorbate, Sorbic acid ...."
• "Testosterone Cream for Men benefits are: .. Increased libido and sexual function ... •Increased lean muscle mass and muscle growth... • Decreased body fat. .. • Increased energy and stamina ..... • Intensifies orgasms and climaxes ...Also helps with: • Improved quality of sleep.
• Reduction in cholesterol levels ... Relief from pain and stiffness in muscles and joints • Increased bone density... • Prevents excess lactic acid and other acid buildup in muscles •Potential decrease in the risk of heart disease ... •Improvement in positive moods ...."
• "TIME RELEASED" LIPOSOME DELIVERY ...."
• "Testosterone is required for the libido, regulating fat, maintaining muscle mass, energy, done density, regulating blood sugar, blood pressure and preventing depression. After the age of 25, the testosterone levels in men begin declining at an average of 1.25% per year resulting in fat deposits, sexual organ shrinkage, heart disease, loss of memory, muscle mass and libido ...."
• "Libido Edge Testosterone for Men is a synergistic formula that combines natural Homeopathy with safe powerful herbal extracts...."
Total HGH Cream
: "Homeopathic Human Growth Factor, Homeopathic IGF-1, Adenosine Triphosphate, Mucuna Pruriens Extract, Vitamin C Ester (Ascorbyl Palmitate), GABA (Gamma Amino Butyric Acid), L-Lysine, L-Tyrosine, Green Tea Extract."
• Additional Ingredients : "Purified Water, Safflower Oil, Aloe Vera, Organic Grain Alcohol, Sepigel305, Evening Primrose Oil, Hemp Seed Oil, Vitamin E Oil, Mandarin Red Oil, Lecithin, Potassium Sorbate, Sorbic Acid" ,
• "Total HGH Cream promotes the burning of fat while increasing lean muscle mass, restoring skin thickness, elasticity, smoothing wrinkles, rejuvenating hair, promoting deeper sleep, improving sexual performance and pleasure...."
• "Homeopathic Clinical Studies have proven that homeopathic HGH can produce virtually all of the benefits that HGH injections did, but without any of the negative side effects."
• "Hgh benefits include: ... • Increase energy levels ... " Improve cholesterol Level ... • Improve immune system strength ... • Equalize blood pressure ... • Strengthen nails and hair...• Improve Sexual function and desire ... • Improve cardiovascular and respiratory functions ...
• Decrease body fat ... • Reduce wrinkles & age spots ... • ... • Restore hair condition and color ... • Improve memory ... • Elevate mood and improve sleep ... • Increase cardiac output and stamina ... • Improve vision ... • Enhances effects of exercise • Increases bone density .
• Lowers blood pressure ...."
Libido Edge Capsules Natural Sexual Enhancement
• "5. Tribulus Terrestris (Bulgarian) .. " [i]t helps with impotence ...."
• "6. Muria Puama Extract is an herb used ... impotence ...."
• "7. Catuaba Bark Extract ... used for ... insomnia ...."
Over-the-Counter (OTC) topical hormone-containing products labeled or promoted for use as drugs are subject to the final rule under 21 CFR § 310.530. This rule states that any OTC drug product, other than hydrocortisone, that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use is regarded as a new drug. Natural Progesterone Cream USP with Adrenal Support , Testosterone Cream Formula FOR WOMEN, and Testosterone Cream Formula FOR MEN fall within this rule because their labeling promotes them as topical hormone-containing products for drug use. Moreover, OTC topical hormone creams are new drugs as defined in section 201(p) of the Act (21 U.S.C. § 321(p)) because there is no evidence that they are generally recognized by qualified scientific experts as safe and effective for their labeled uses. (See 21 CFR § 310.530.) Since Natural Progesterone Cream USP with Adrenal Support, Testosterone Cream Formula FOR WOMEN, and Testosterone Cream Formula FOR MEN are not the subjects of approved new drug applications, their marketing in the United States violates section 505(a) of the Act, [21 U.S.C. § 355(a)].
We recognize that the labeling for Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN identifies them as containing "Homeopathic Human Growth Factor." We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in FDA's Compliance Guide entitled, "Conditions under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG). The CPG defines a homeopathic drug as: "Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution." Further, the CPG states that drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.
Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN contain ingredients that are not recognized active ingredients in the HPUS or any of the addenda or supplements. Furthermore, to our knowledge, none of these ingredients are listed in any recognized materia medica containing information on the preparation of homeopathic medication.
Therefore, the above listed ingredients are not homeopathic ingredients and Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN are not considered homeopathic drugs under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to this product. Therefore, these products are new drugs as defined by section 201(p) of the Act, [21 U.S.C. § 321(p)]. Since Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN are not the subjects of approved new drug applications, their marketing in the United States violates sections 505(a) of the Act, [21 U.S.C. § 355(a)].
Distribution of products containing human growth hormone also violates section 303(e)(1) of the Act, [21 U.S.C. § 333(e)(1)]. Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN are being promoted and distributed on your website for unapproved uses. There are no human growth hormone products that are approved by the FDA for burning of fat, increasing lean muscle mass, restoring skin thickness, elasticity, smoothing wrinkles, rejuvenating hair, promoting deeper sleep, improving sexual performance, and pleasure. Section 303(e)(1) of the Act, [21 U.S.C. § 333(e)(1)] states that "whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under 21 U.S.C. § 355 and pursuant to the order of a physician, is guilty of an offense, punishable by not more than 5 years in prison, such fines as are authorized by Title 18, United States Code, or both." You possess, promote, and distribute Total HGH Cream, Testosterone Cream Formula FOR WOMEN and Testosterone Cream Formula FOR MEN for unapproved uses. Your conduct therefore violates 21 U.S.C. § 333(e)(1).
Additionally, any OTC drug product that is labeled, represented, or promoted for use as an aphrodisiac, such as the disease condition, "impotence", like Libido Edge Capsules Natural Sexual Enhancement are subject to 21 CFR Part 310.528. These regulations require that such drugs have an approved application under section 505(b) of the Act, [21 U.S.C. § 355(b)] before they can be marketed. Thus, Libido Edge Capsules Natural Sexual Enhancement violates section 505(a) of the Act, [21 U.S.C. § 355(a)].
Further, since the adequacy of the indications for the labeled uses for these products have not been established, Natural Progesterone Cream USP with Adrenal Support, Testosterone Cream Formula FOR WOMEN, Testosterone Cream FOR MEN, Total HGH Cream, and Libido Edge Capsules Natural Sexual Enhancement are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
Lastly, Natural Progesterone Cream USP with Adrenal Support, Testosterone Cream Formula FOR WOMEN, Testosterone Cream FOR MEN, Total HGH Cream, and Libido Edge Capsules Natural Sexual Enhancement are misbranded under section 502(0) of the Act [21 U.S.C. § 352(o)], because they were not manufactured, prepared, propagated, compounded or processed in an establishment duly registered under section 510 of the Act (21 U.S.C. § 360), nor were they included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. A description of the new drug approval process can be found on FDA's internet website at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Appro
valApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the awarding of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to Stephen J. Rabe, Compliance Officer at the address listed in the letterhead.
Teresa C. Thompson