Sunergized LLC

WARNING LETTER Sunergized LLC MARCS-CMS 548703 — May 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Express Delivery Recipient: Recipient Name James Scarmozzino Sunergized LLC 217 Woodbury Rd #84 Woodbury , NY 11797 United States Issuing Office: Center for Food Safety and Applied Nutrition United States WARNING LETTER MAY 18 2018 VIA EXPRESS DELIVERY James Scarmozzino, Owner Sunergized  LLC 217 Woodbury Rd #84 Woodbury, NY 11797 Re: 548703 This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.sunergeticproducts.com in March 2018 and has determined that you take orders there for the product Sunergetic. The claims on your website and product label establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.  You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov . Examples of some of the website claims that provide evidence that your Sunergetic product is intended for use as a drug include: From your Sunergetic product reviews: • “My dermatologist recommended the herb in this product for repairing sun damage.” • “[J]oint pains especially in the morning has lessened” • “I … have had my share of sunburns in the past. When I use this supplement in the morning I can be out in hot sun all day with only one application of sunscreen and not get at all pink.” • “It’s basically an oral sunscreen…This would be especially useful for people who have had skin cancer, are at risk for skin cancer….” • “This product has helped … protect me from the harms of radiation.” Examples of some of the product label claims that provide evidence that your Sunergetic product is intended for use as a drug include: • “Take an additional capsule if exposed to excess sunlight…” Your Sunergetic product is not generally recognized as safe and effective for the above referenced use and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. This letter is not an all-inclusive statement of violations associated with your product or its labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act. We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. You should direct your written reply to Beth Tirio, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Tirio via email at beth.tirio@fda.hhs.gov . Sincerely, /s/ William Correll Director Office of Compliance Center for Food Safety and Applied Nutrition US Food and Drug Administration Cc: ORA/OHAFO 1E Close Out Letter Sunergized LLC - Close Out Letter 6/19/18 Content current as of: 05/21/2018