Department of Health and Human Services
|Food and Drug Administration|
Silver Spring, MD 20993-0002
Sent via email: firstname.lastname@example.org; email@example.com
August 4, 2015
1121 C Military Cutoff Road
Wilmington, NC 28405
Re: ImmunoKinoko AHCC, XtraCell Thymus, Aloe 200x, Vitalzym, Carnitine Synergy 500 mg
Caps, EGCg 250 mg (Green Tea Extract), Stabilized R-Lipoic Acid Supreme, and Milk Thistle
Dear Mr. Stockman,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.rockwellnutrition.com in April 2015 and has found that you offer for sale ImmunoKinoko AHCC, XtraCell Thymus, Aloe 200x, Vitalzym, Carnitine Synergy 500mg Caps, Stabilized R-Lipoic Acid Supreme, and Milk Thistle Plus in violation of the Federal Food, Drug, and Cosmetic Act. Various claims and statements made on your website(s) and/or in other labeling cause your products to be drugs. As explained further below, the introduction of these products into interstate commerce violates 21 U.S.C. § 331(d).
Your products listed above are drugs under 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of flu, cancer, rheumatoid arthritis, asthma, fibromyalgia, HIV, Hepatitis, bronchial infections, high cholesterol, diabetes, cirrhosis, and Alzheimer’s disease. These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for uses recommended or suggested in their 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 products do not have FDA-approved applications as required by 21 U.S.C. § 355.
We advise you to review all express or implied claims you make for your products and to remove such claims that cause your products to be drugs (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 materials, and removing product claims, consumer testimonials, meta-tags, and anything else that states or implies that your products are 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 at the top 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 for the products listed above continue to recommend or suggest the use of the products to treat, cure, mitigate, or prevent diseases, your firm and these products will be listed 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