- Delivery Method:
- Via Overnight Delivery
- Animal & Veterinary
- Issuing Office:
- Center for Veterinary Medicine
Date: July 21, 2020
RE: Unapproved New Animal Drug Products
Dear Dr. Fishman:
This letter concerns your firm’s sale of veterinary products for the treatment of disease in aquarium fish, including all dosage forms of the following Fishman Chemical products: doxycycline hyclate, enrofloxacin, erythromycin, kanamycin sulfate, metronidazole, neomycin sulfate, lincomycin HCL, nitro green, oxolinic acid, oxytetracycline, and TMP/sulfa.
In June, 2020 the U.S. Food and Drug Administration (FDA) reviewed your website (http://www.fishchemical.com/), where you take orders for these products. The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Examples of claims observed on your website (https://www.fishchemical.com/FULL-PRODUCT-LIST-2338.Category.html) that establish the intended use of your products as drugs include, but may not be limited to, the following:
• Doxycycline Hyclate
o “a broad spectrum antibiotic derived from Oxytetracycline. Used for both gram-positive and gram-negative bacterial disorders, fin & tail rot, septicemia, and mouth rot.”
o “…also knows as Baytril, is made by Bayer Pharmaceuticals. It is a fluoroquinolone antibiotic also knows as Ciprofloxacin (Cipro) for humans. This is a third generation antibiotic and is the most advanced antibiotic approved for use in tropical fish.”
o “…excellent choice to fight Pop Eye, fin and tail rot and red slime. It fights both gram negative and gram positive bacterias. A very good all around antibiotic.”
• Kanamycin sulfate
o “…salt water situations to fight gram negative bacteria and most forms of tuberculosis.”
• Lincomycin HCL
o “As Kanamycin is being restricted more by the FDA. Fishman Chemical has sourced a viable replacement. …Lincomycin which is more commonly known in the fish community as Clindamycin.”
o “Very effective in the fight against protozoan, hole in the head disease, internal hexamita (Malawi bloat), freshwater ICH and pond epistyles.”
• Neomycin sulfate
o “…used to kill gram negative bacteria in both fresh water and salt water environments. It is also used to fight tuberculosis.”
• Nitro green (contains sulfathiazole sodium, as well as nitrofurazone, methylene blue and sodium chloride)
o “Anti- microbial, anti- protozoan, anti-bacterial, anti-fungal. Wide spectrum.”
• Oxolinic acid
o “Anti-bacterial, gram negative bacteria. Used when fish die for no apparent reason, when other medications are not helpful.”
o “very popular antibiotic because it can be used to treat both gram-positive and gram-negative bacteria. The hydrochloride is 99% or higher active. Oxytetracycline is used to kill marine ulcer disease, mouth fungus, cold water disease and bacterial hemorrhagic septicimea. It is a good all around antibiotic.” [sic]
o “…treat almost all of the diseases that doxycycline will treat with the exception of some gram positive bacteria and fungi.”
These products are new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because they are intended for use in a minor species, as defined in section 201(oo) of the FD&C Act, and are not the subject of a final FDA regulation finding that the drugs are 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 drug’s labeling or finding that the drugs have been grandfathered under the provisions of section 201(v)(1) of the FD&C Act. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)].
This letter notifies you of our observations and provides you an opportunity to address the circumstances above. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and injunction.
In addition to the aforementioned drug products, FDA’s June, 2020 review of your website (https://www.fishchemical.com/FULL-PRODUCT-LIST-CHLOROQUINE-PHOSPHATE-22937.Item.html ) showed that you continue to offer for sale chloroquine phosphate, an adulterated new animal drug, for which you received a Warning Letter dated April 15, 2020. To date, the FDA has not received the requested response to this Warning Letter, describing your proposed corrective actions for the violation, nor have you responded to our voicemail of April 20, 2020. We request that you provide a response to the April 15th Warning Letter immediately.
The violations cited in this letter and FDA’s April 15, 2020, Warning Letter are not intended to be an all-inclusive statement of violations that exist in connection with your products or operations. Our review of your website showed that you are offering for sale unapproved new animal drugs in addition to those listed above. Any unapproved drug intended to treat disease in fish or affect the structure or function of the body of fish is an adulterated new animal drug that cannot be legally introduced into interstate commerce, and we may take action against it at any time. Further, if FDA takes legal action, it may include all of your adulterated new animal drugs, not just those listed above. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA’s implementing regulations.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to Eric Nelson, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Compliance, MPN4, 12225 Wilkins Avenue, Rockville, MD 20852 or by e-mail to Eric.Nelson@fda.hhs.gov.
Mr. Eric M. Nelson
Director, Division of Compliance
Center for Veterinary Medicine
Food and Drug Administration