WARNING LETTER
Silver Lease, LLC
MARCS-CMS 664592 —
November 30, 2023
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Dan Keen
Silver Lease, LLC
530-B Harkle Road, Ste 100
Santa Fe
,
NM
87505
United States
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
November 30, 2023
Re: CMS 664592
Dear Dan Keen:
This letter concerns your firm's manufacture and distribution of veterinary products for use in aquarium fish:
In August 2023, the U.S. Food and Drug Administration (FDA) reviewed the websites https://www.allivet.com/ and https://www.lambertvetsupply.com/, where these distributors take orders for the following products you manufacture: Fishbiotic Cephalexin, Fishbiotic Doxycycline, and Fishbiotic SMZ/TMP. The labels of these products can be seen on these websites. The claims on the labels establish that they are intended for use in the cure, mitigation, treatment, or prevention of diseases 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)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
UNAPPROVED NEW ANIMAL DRUGS
Examples of product label claims observable on the websites (https://www.allivet.com/ and https://www.lambertvetsupply.com/) that establish the intended use of your products as drugs include, but may not be limited to, the following:
Fishbiotic, Cephalexin 500 mg
, capsules. The product label states: “This product is an antibacterial medication. Uses: Infected Eyes, Fin or Tail Rot, Skin Ulcerations, Pop-Eye, Columnaris Disease, and Gill Disease.”
Fishbiotic, Doxycycline 100 mg
, capsules. The product label states: “This product is a broad spectrum antibiotic. It works by stopping the growth of bacteria. Uses: Infected Eyes, Fin or Tail Rot, Skin Ulcerations, Pop-Eye, Columnaris Disease, and Gill Disease.”
Fishbiotic SMZ/TMP, Sulfamethoxazole/Trimethoprim
, 800 mg/160 mg, tablets. The product label states: “Sulfamethoxazole and Trimethoprim combination is an antibiotic that works by eliminating the bacteria caused by many types of infections. Uses: Infected Eyes, Fin and Tail Rot, Skin Ulcerations, Pop-eye, Columnaris Disease, and Gill Disease.”
These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either 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 exception to the criterion in section 201(v)(1) of the FD&C Act has been met.
To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a 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, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed.
Animal drugs that lack the required approval or index listing are considered 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 or delivery for 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)].
FDA is particularly concerned about your unapproved animal drugs because they raise public health concerns. Available as over-the-counter drugs, they contain antimicrobials that are considered medically important in the treatment of human disease.
1
Concern about the development of resistance to antimicrobials important in human medicine has led FDA to promote more judicious use of animal drugs containing medically important antimicrobials, including working toward ensuring that these drugs can be used in animals only under the supervision of a licensed veterinarian.
MISBRANDED NEW ANIMAL DRUGS
Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.
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 violations 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 adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and/or injunction.
You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of any unapproved/unindexed products.
We have the following comments:
1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at
https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and
https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications
The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species.
2. Information on establishment registration and drug listing is available on the FDA website at:
https://www.fda.gov/industry/fda-basics-industry/registration-and-listing
Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that 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 actions within fifteen (15) working days, 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 written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov.
Sincerely,
/S/
Neal Bataller, ME, DVM
Director Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
______________________________
1
A list of medically important drug classes of antimicrobials can be found in Guidance for Industry (GFI) # 152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern,” available at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf
Content current as of:
12/14/2023
Regulated Product(s)
Animal & Veterinary
Drugs