Department of Health and Human Services
|Food and Drug Administration|
Silver Spring, MD 20993-0002
Sent via email: firstname.lastname@example.org
November 20, 2015
Life Decoders, LLC
2711 Centerville Rd, Suite 400
Wilmington, DE 19808-1645
Re: Sheep Placenta Advanced Capsules
Dear Life Decoders, LLC:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.stemcelltherapyplus.com in September 2015 and has found that you offer for sale Sheep Placenta Advance Capsules in violation of the Federal Food, Drug, and Cosmetic Act. Various claims and statements made on your website and/or in other labeling cause your product to be a drug. As explained further below, the introduction of this product into interstate commerce violates 21 U.S.C. § 331(d).
Your product listed above is a drug under 21 U.S.C. § 321(g)(1)(B) because it is intended for the treatment, cure, mitigation, or prevention of serious disease. Examples of serious diseases for which your product is marketed include Alzheimer's disease, cancer, diabetes, heart disease, multiple sclerosis, and Parkinson's disease. This product is also a new drug as defined under 21 U.S.C. § 321(p) because it is not generally recognized as safe and effective for uses recommended or suggested in its labeling. To be legally marketed, a new drug must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. See 21 U.S.C. §§ 355(a) and 331(d). Your drug product does not have an FDA-approved application as required by 21 U.S.C. § 355.
We advise you to review all express or implied claims you make for your product and to remove such claims that cause your product to be a drug (i.e., claims suggesting that your product is intended for treating, curing, mitigating, or preventing one or more diseases). This includes reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts) as well as any other promotional material, and removing product claims, consumer testimonials, meta-tags, and anything else that states or implies that your product is useful in treating, curing, mitigating, or preventing diseases.
For more information on the kinds of claims that cause products to be drugs, please see 21 CFR 101.93(f)-(g) and http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm.
Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify FDA, via electronic mail at FDAadvisory@fda.hhs.gov or via mail to CDR Jason Humbert at 12420 Parklawn Drive #4041, Rockville, MD 20857, that the violations have been corrected. Include the Online Advisory Letter Reference number (located in the upper right portion of this letter) in all your communications to FDA regarding this matter.
After 30 days of the date of this letter, if your website(s), labeling, or other promotional materials continue to recommend or suggest the use of products to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for products illegally marketed for serious diseases.
This letter is not intended to be an all-inclusive review of your website(s) or a list of all violations of law that exist in connection with your products, your website(s) and other product labeling, or at your facilities. FDA expects you to take the necessary steps to ensure that all your products comply with the laws and regulations enforced by FDA.
Health Fraud Team
Office of Enforcement and Import Operations
Office of Regulatory Affairs
U.S. Food and Drug Administration