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WARNING LETTER

August 15, 2022

RE: 639799

Dear (b)(6):

This is to advise you that in May 2022, the United States Food and Drug Administration (FDA) reviewed your website and eBay store at the Internet addresses https://www.petdefenderproducts.com/ and https://www.ebay.com/sch/first_strike_pet_supply/m.html?_nkw=&_armrs=1&_ipg=&_from= where you offer for sale in the United States the following products:

• Strike-pyram (nitenpyram) Bulk Oral Powder [various dosages for various size dogs and cats]
• Strike-nuron (lufenuron) Bulk Oral Powder [various dosages for various size dogs and cats]
• First Strike Natural Flea and Tick Powder [multiple sizes]
• Strike 30 [for various size dogs and cats]
• Strike 30 Flea Elimination Capsules for Cats and Dogs (micro capsules and powder only)
• First Strike De-wormer (praziquantel and pyrantel pamoate) [for various size dogs and cats]
• Bulk Combo-Package, First Strike – Strike-pyram and Strike-nuron flexi-packs [various dosages for various size dogs and cats]
• First Strike Nitenpyram [various dosages for various size dogs and cats]
• De-wormer (praziquantel) [various dosages for various size dogs and cats]
• Strike-nuron Bulk Powder [various dosages for various size dogs and cats]
• First Strike - Strike-pyram Bulk Powder [various dosages for various size dogs and cats]
• First Strike Lufenuron [various dosages for various size dogs and cats]
• First Strike Nitenpyram + Lufenuron [various dosages for various size dogs and cats]
• Super Pack 30 Day Flea Killer and De-wormer

FDA also reviewed your product labels. Based on our review, your products are unapproved new animal drugs. As discussed below, marketing of unapproved new animal drugs violates the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The claims on your website, eBay store, and product labeling establish that your products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Examples of claims on your website, eBay store, and product labeling that establish the intended uses of your products include, but are not limited to, the following:

Strike-pyram (Nitenpyram) Bulk Oral Powder:
o Found at https://www.petdefenderproducts.com/product-page/25-countsample-packs-wholesale-only

• “A Bulk oral powder for Cats and Dogs 2 pounds and up”
• “Eliminates adult fleas”
• “Provides up to 48 hours of adult flea elimination”
• “Proven safe and non-toxic”

Strike-nuron (Lufenuron) Bulk Oral Powder:
o Found at https://www.petdefenderproducts.com/product-page/25-countsample-packs-wholesale-only

• “A Bulk oral powder for Cats and Dogs 2 pounds and up”
• “Eliminates hatching fleas”
• “Provides up to 30 days of flea control”
• “Breaks the flea life cycle”

Strike 30:
o Found at https://www.petdefenderproducts.com/product-page/strike-30-medium-dog-40-to-60-pounds-6-capsules and https://www.petdefenderproducts.com/product-page/strike-30-for-large-dogs-60-to-120-pounds-6-capsules:

• “This product is vastly more effective than all other flea killers. You will not need 100 count bottles simply one use per month”
• “…Strike-30 (Flea elimination for up to 30 days) targets and eliminates adult biting fleas when they feed on your pets(s).”
• “Kills all type of adult biting fleas”
• “Fast acting 30 minute flea elimination”
• “Pets MUST be over 14 weeks old…”
• “Strike-30 starts working in 30 minutes eliminating fleas by targeting the central nervous system of most biting insects, causing rapid death (does not kill ticks but many other biting insects)…”
• “The value is that all biting fleas die and that your pet no matter of what level of infestation it’s exposed is protected [sic]”
• “Additional hatching generations of fleas will also die if they are present if they feed on your pet”

o Found at https://www.petdefenderproducts.com/product-page/strike-30-micro-capsules-count-70-140-mg

• “… most effective long term flea killer”
• “… provides fast acting adult flea killing power for up to 30 days”

o Found at https://www.petdefenderproducts.com/product-page/strike-30-fleakiller-for-pets-6-to-20-pounds-60-capsule-count

• “30 days of flea elimination”
• “Eliminates biting adult fleas”
• “For cats and dogs 14 weeks and older”

Bulk Combo-Package (Strike-pyram and Strike-nuron flexi-packs):
o Found at https://www.petdefenderproducts.com/product-page/super-bulkcombo-flea-killer-34-gram-and-34-gram-flea-control

• “This is an oral product that is added to canned pet food for a super easy application. It comes with measuring scoops for easy measuring… (As with all bulk products we suggest a digital scale to ensure exact amounts)”
• “Flea killer Application: When flea infestation is present or given after a potential exposure to fleas. Determine pets weight and apply one of the following applications (Never exceed the recommended doses in a 24 hour period) Cats and small dogs 2 to 7 pounds 6mg, 7 to 25 pounds: 12 milligrams Medium and Large Dogs 30 to 125 pounds: 57 milligrams”
• “Flea Control Application: One measured dose (instructions and tool provided) given once a month. Best used with a fatty canned food or meal.”
• “Suggested application per pet, Flea Control: For dogs is 5 mg/lb (to 10 mg per kilogram of your pet's weight) once monthly. For cats, 15 mg/lb (30 mg per kilogram of your pet's weight) once monthly. Example: A five-pound cat would need a 75 mg dose (for 67 potential future applications)”
• “Only one application per 48 hours. It is not necessary to give more than three applications per week even if moderate to heavy infestation is present.”

o Found at https://www.ebay.com/itm/304138941646?hash=item46d017f4ce:g:qSoAAOSwCAxiPudQ

• “Industry standard uses are: 90mg for cats and small dogs, 205mg for medium sized dogs and 500mg for large dogs. You can give specific or industry standard applications”

First Strike - Strike-pyram Bulk Powder:
o Found at https://www.petdefenderproducts.com/product-page/bulk-fleakiller-10-gram-package-with-scoops

• “An oral powder for the elimination of fleas for multi pet homes”
• “What is Strike-pyram? (Flea Killer) targets and eliminates adult biting fleas when they feed on your pet. Strike-pyram starts working in 30 minutes eliminating fleas by targeting the central nervous system of fleas and biting insects, causing rapid death. Providing protection 24 to 48 hours. Works well in conjunction with strike-fenuron (Flea Control) and other non-toxic flea control products.”
• “Application: When flea infestation is present or given after a potential exposure to fleas.”
• “Determine pets weight and apply one of the following applications: Cats and small dogs 2 to 25 pounds: 12 milligrams Medium and Large Dogs 30 to 125 pounds: 57 milligrams”
• “Only one application per 48 hours. Do not exceed three applications per week if moderate to heavy infestation is present”

Strike-nuron Bulk Powder:
o Found at https://www.petdefenderproducts.com/product-page/10-gram-fleacontrol-bulk-powder-cats-and-dogs

• “For Cats and dogs 2 to 30 pounds. Dose is 165mg in powder form”
• “Flea control (Does not kill adult fleas) on Cats and Small Dogs”
• “Suggested application per pet: For dogs is 5 mg/lb ( to 10 mg per kilogram of your pet's weight) once monthly.For [sic] cats, 15 mg/lb (30 mg per kilogram of your pet's weight) once monthly”
• “30 Day Flea Control, Targets hatching fleas”
• “Flea Control also known as Lufenuron (Also known as Program) is stored in the animal's body fat and transferred to adult fleas through the host's blood when they feed. Adult fleas transfer it to their growing eggs through their blood, and to hatched larvae feeding on her excrement. It does not kill adult fleas. Lufenuron, inhibits the production of chitin insects. Without chitin, a larval flea will never develop a hard outer shell (exoskeleton). With its inner organs exposed to air, the insect dies from dehydration soon after hatching or molting (shedding its old, smaller shell). It has no toxic effects at any dosage on humans other mammals or any animals not having hard shells.”

First Strike Nitenpyram capsules:
o Found at https://www.petdefenderproducts.com/product-page/copy-of-fleakiller-for-cats-and-small-dogs

• “Nitenpyram (Also known as Capstar) is a fast acting, orally administered flea treatment… provides 100% kill of all fleas on the animal at the time of treatment and for up to 24 hours after treatment (We found that it is some time effective for longer periods of time up to 48 hours)”

First Strike De-wormer (praziquantel and pyrantel pamoate):
o Found at https://www.petdefenderproducts.com/product-page/spectrumdewormer-for-large-dogs-12-capsules

• “Praziquantal and Pyrantel Pamoate For the prevention and elimination of common worms in Dogs”
• “12 - Flavored Capsules, 250 milligrams of Praziquantel and 250 mg of Pyrantel ( Broad Spectrum = Tape, Hook, Round and Whipworms)”
• “For the elimination of Tape, Hook, Round and Whipworms”
• “One capsule will eliminate a tapeworm infestation per pet”
• “One capsule given every ten days ( 1st, 10th 20th day) for a total of three capsules will eliminate all other worm types ( parasites )”

Super Pack 30 day Flea killer and De-wormer:
o Found at https://www.ebay.com/itm/304138941105?hash=item46d017f2b1:g:BqUAAOSwPJxe8YkQ

• “FLEA KILLER CAPSULES PROVIDE UP TO 30 DAYS OF FLEA KILLING PROTECTION PER CAPUSLE”
• “BROAD SPECTRUM DE-WORMER TO PREVENT INTERNAL PARASITES”
• “Super packs consist of two products. Our Strike 30 flea killer product and a broad spectrum de-wormer that eliminates the four most common internal parasites”
• “Broad spectrum De-Wormer eliminates any pre-existing tape worm infestation that is common with previous flea infestations or in most pets. One capsule eliminates a tapeworm infestation. A capsule given every 10 days eliminates all common parasites (ring, round, whip and tape worms)”

Based on our review, these products are new animal drugs under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not 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, new animal drugs 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 products 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. 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). The introduction or delivery for introduction into interstate commerce of adulterated drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).

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.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. You are responsible for investigating and determining the cause 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’s implementing regulations.

Within fifteen (15) working days 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 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

Please direct your response to the Dr. Vic Boddie, U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Compliance, [email protected].

Sincerely,
/S/

Neal Bataller, ME, DVM
Director, Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration