Dr. G's Marine Aquaculture, Inc.

WARNING LETTER Dr. G's Marine Aquaculture, Inc. MARCS-CMS 606979 — April 15, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Animal & Veterinary Recipient: Recipient Name Ms. Elena Ninoua-Gonzalez Dr. G's Marine Aquaculture, Inc. 20841 Johnson Street, 110 Pembroke Pines , FL 33029 United States drgsphyto@gmail.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: April 15, 2020 RE: Unapproved Chloroquine Phosphate Product Dear Ms. Ninoua-Gonzalez: This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address http://www.drgsmarineaquaculture.com in April 2020. The FDA has observed that your website offers Dr. G’s Anti-Parasitic Caviar for sale in the United States. Based on our review, this product is adulterated. The introduction or delivery for introduction into interstate commerce of any food or drug that is adulterated is a prohibited act. (Section 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 321(a)].) Your Dr. G’s Anti-Parasitic Caviar product is a drug under Section 201(g)(1)(B) of the FD&C 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 in animals. Some examples of the claims on your website, where you sell Dr. G’s Anti-Parasitic Caviar, http://www.drgsmarineaquaculture.com/anti-parasitic-caviar-detail.cfm, that establish the intended uses of your product include: • “Treats Ich, Brooklynella, Uronema, Crypto, Oodinium and many more Ornamental Fish Parasites.” • “Effective new treatment for several forms of marine and freshwater Parasites, that can harm or kill your fish.” • “Treats your Fish, Not your Water!” • “Our unique formula provides the Anti-Parasitic efficiency of Chloroquine plus the premium nutritional value of Dr.G's Caviar MAX, made with the finest and freshest ingredients.” Dr. G’s Anti-Parasitic Caviar is intended for use in fish, a “minor species,” as defined in section 201(oo) of the FD&C Act [21 U.S.C. § 321(oo)]. Therefore, your Dr. G’s Anti-Parasitic Caviar product is a new animal drug under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because it is not the subject of a final FDA regulation published through notice and comment rulemaking finding that the drug has been generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, or 360ccc-1], respectively. Dr. G’s Anti-Parasitic Caviar has not been approved, conditionally approved, or index listed. New animal drugs that lack the required approval or index listing are "unsafe" and "adulterated" under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Your product’s labeling includes the claim, “provides the Anti-Parasitic efficiency of Chloroquine,” demonstrating the intended use of chloroquine as a drug. Chloroquine is a new animal drug under section 201(v) of the FD&C Act. It has not been approved, conditionally approved or index listed for use in ornamental fish. Therefore, chloroquine is an unsafe new animal drug within the meaning of section 512(a) of the FD&C Act. Your Dr. G’s Anti-Parasitic Caviar is accompanied by labeling including the statement, “To ‘Treat’ Parasitic infections, use as regular food twice a day for up to 3 weeks. To ‘Prevent’ Parasitic infections, use as regular food twice a day for up to 3 weeks.” As defined by section 201(w) of the FD&C Act [21 U.S.C. § 321(w)], an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animals is an “animal feed.” To the extent your Dr. G’s Anti-Parasitic Caviar is an animal feed that contains the unsafe new animal drug chloroquine, it is an unsafe animal feed within the meaning of section 512(a)(2) of the FD&C Act [21 U.S.C. 360b(a)(2)]. Such an unsafe animal feed is an adulterated drug within the meaning of section 501(a)(6) of the FD&C Act [21 U.S.C. 351(a)(6)]. Finally, to the extent your Dr. G’s Anti-Parasitic Caviar is a “food,” as defined by section 201(f) of the FD&C Act [21 U.S.C. § 321(f)], 1 it is an adulterated food within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. 342(a)(2)(C)(ii)], which states that a food is adulterated if it bears or contains a new animal drug that is unsafe within the meaning of section 512 of the FD&C Act. As noted above, chloroquine is an unsafe new animal drug within the meaning of section 512(a) of the FD&C Act. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within 48 hours, please send an email to the contact person below , describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your response should be sent via e-mail to Dr. Vic Boddie at Vic.Boddie@fda.hhs.gov. If you have any questions about this letter, please contact Dr. Boddie at 240-402-5618 . Sincerely, /S/ Mr. Eric M. Nelson Director, Division of Compliance Center for Veterinary Medicine Food and Drug Administration ___________________________ 1 Your labeling states that your Dr. G’s Anti-Parasitic Caviar contains Dr. G’s Caviar MAX (capelin (Mallotus villosus) eggs), Dr. G’s Reef Essentials vitamins and amino acids, and garlic. Content current as of: 04/16/2020 Regulated Product(s) Animal & Veterinary