Sent via email: email@example.com
February 13, 2017
Craig Pisaris-Henderson, CEO
CellMark Biopharma LLC
1591 Hayley Ln
Fort Myers, FL 33907
Dear Craig Pisaris-Henderson:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.cellmarkbiopharma.com in November 2016 and has found that you take orders there for CellAssure. Various claims and statements made on your website and/or in other labeling establish that this product is a drug as defined in 21 U.S.C. § 321(g)(1)(B) because it is intended for the treatment, cure, mitigation, or prevention of disease. For example, your website recommends or suggests the use of CellAssure to treat or prevent cancer. As explained further below, the introduction of this product into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act.
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 the uses recommended or suggested in its 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 product does 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 use of your product, and to either submit a new drug application (NDA) for the product intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your product is intended for such uses. This would include reviewing your websites, product label, 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 product is 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 postal 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 portion of this letter) in all your communications to FDA regarding this matter.
After 30 days from the date of this letter, if your websites or other labeling continue to demonstrate that your product is 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 product(s), 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