Food and Drug Administration
Silver Spring, MD 20993-0002
June 29, 2017
RE: Comglycan Essence, Red Yeast Rice Supreme, and Corpo CoQ10
Dear Hysen USA:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at hysenusa.com in June 2017 and has found that you take orders there for Comglycan Essence, Red Yeast Rice Supreme, and Corpo CoQ10. Various claims and statements made on your website and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. For example, your website recommends or suggests the use of Comglycan Essence, Red Yeast Rice Supreme, and Corpo CoQ10 to treat or prevent cancer, congestive heart failure, hypertension, hypercholesterolemia, diabetes, cardiovascular disease, arteriosclerosis, heart failure, myocardial infarction, and viral hepatitis. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act.
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 the uses recommended or suggested in their labeling. Before a new drug may be marketed or otherwise introduced into interstate commerce, it 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 materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. This would include 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, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.
For more information on the kinds of claims that establish that a product is intended for use as a drug, 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 ORA Health Fraud, 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 from the date of this letter, if your website or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for unapproved new drugs 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