WARNING LETTER
Fishman Chemical of North Carolina, LLC
MARCS-CMS 606978 —
April 15, 2020
Product:
Animal & Veterinary
Recipient:
Recipient Name
Dr. David A. Fishman
Fishman Chemical of North Carolina, LLC
624 Old Dixie Hwy
Vero Beach
,
FL
32962
United States
sales@fishchemical.com
grace@fishchemical.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
Date: April 15, 2020
RE: Unapproved Chloroquine Phosphate Product
Dear Dr. Fishman:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address http://www.fishchemical.com in April 2020. The FDA has observed that your website offers Chloroquine Phosphate for sale in the United States. Based on our review, this product is an adulterated drug. The introduction or delivery for introduction into interstate commerce of any 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 Chloroquine Phosphate 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 Chloroquine Phosphate for the treatment of tropical fish, https://www.fishchemical.com/FULL-PRODUCT-LIST-CHLOROQUINE-PHOSPHATE-22937.Item.html, that establish the intended uses of your Chloroquine Phosphate product include:
•“Chloroquine is used as a bacteriacide, an algaecide and as an antimalarial.”
•“It is superior in the fight against ICH, slimness of the skin and flukes and can be used as both a treatment and a preventative.”
The above description is accompanied by a photograph of multicolored ornamental fish.
Your Chloroquine Phosphate product 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 Chloroquine Phosphate 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. The animal drug named above 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)].
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
Content current as of:
04/16/2020
Regulated Product(s)
Animal & Veterinary