WARNING LETTER
Mr Frags, LLC
MARCS-CMS 611295 —
October 19, 2020
Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Jason Weage/Jason Coral
Mr Frags, LLC
5598 Highbury Dr SE
Ada
,
MI
49301
United States
jason@mrfrags.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
Date: October 19, 2020
RE: Unapproved Chloroquine Phosphate Product
RE: [611295]
Dear Jason Weage:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://mrfrags.com/ in October 2020. The FDA has observed that your website offers chloroquine phosphate for sale in the United States. We also reviewed the labels on these products. Based on our review, these products are 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. § 331(a)].)
Your chloroquine phosphate products are drugs under Section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.
Some examples of the claims on your website and product labels that establish the intended uses of your products include:
On your product labels for chloroquine phosphate:
“For treatment of Cryptocaryon irritant (ich), Amyloodinium ocellatum (Marine Velvet) and Brooklynella (brook)”
On your product page description for chloroquine phosphate:
“Chloroquine Phosphate is a replacement for both copper sulfate and quinine and it is superior to copper sulfate and all quinine salts. Chloroquine is used as a bacteriacide, an alagecide 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.”
“You can check out the most recent article on Advanced Aquarist By Jay Hemdal Chloroquine: A “New” Drug for Treating Fish Disease”
“There are also some other media/books that talk about using chloroquine phosphate as treatment.”
Chloroquine phosphate 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 products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are 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. Your chloroquine phosphate products have 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and injunction.
Within 48 hours of receipt of this letter, please notify this office in writing
of the specific steps you have taken to correct any 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 believe that your products are not 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:
10/27/2020
Regulated Product(s)
Animal & Veterinary
Drugs