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WARNING LETTER

Date: October 6, 2020

RE: Unapproved New Animal Drug Products

RE: [610530]

Dear Ms. Edwards:

This is to advise you that in August and September 2020, the United States Food and Drug Administration (FDA) reviewed your website at the internet address, www.everythingaquatic.net. The FDA has observed that you offer for sale in the United States veterinary products¹ for the use in aquarium species, including Chloroquine Phosphate products.² The claims on your website establish that these products are drugs under Section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals or because they are intended to affect the structure or function of the body of animals. Based on our review, as discussed below, these products are unapproved new animal drugs. An unapproved new animal drug is unsafe under 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)]. Introducing or delivering for introduction into interstate commerce adulterated drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Statements on your website that establish the intended uses of your products include, but are not limited to, the following:

Chloroquine Pellet
• “Chloroquine Pellet is used as both a treatment option and a preventative. It is a bacteriacide, algaecide and antiparasitic medication. An excellent general cure as well as a focused treatment against ICH, excess slim coat and flukes. Chloroquine phosphate has been gradually replacing copper sulfate and quinine as the drug of choice due to its superiority.”

Chloroquine Flake
• “Chloroquine Flake is used as both a treatment option and a preventative. It is a bacteriacide, algaecide and antiparasitic medication. An excellent general cure as well as a focused treatment against ICH, excess slim coat and flukes. Chloroquine phosphate has been gradually replacing copper sulfate and quinine as the drug of choice due to its superiority.”

Chloroquine Phosphate Powder
• “Chloroquine Phosphate can be used as both a treatment option and a preventative. It is a bacteriacide, algaecide and antiparasitic medication. An excellent general cure as well as a focused treatment against ICH, excess slim coat and flukes. Chloroquine phosphate has been gradually replacing copper sulfate and quinine as the drug of choice due to its superiority.”
• “It has shown to be effective against most protozoans and tapeworms as well as external parasites.”
• “To treat protozoan infections a single dose of 60mg/g (15 mg/l) is all that is necessary.”

Medicine Cabinet
• “No one ever plans on having to deal with disease in their aquarium, but there will come that day when something goes wrong. It is inevitable. Our Medicine Cabinet includes equal amounts of 6 types of medicated flake at a discounted price. Stock up and don't be caught off guard!”

Doxycycline Hyclate
• “Doxycycline Hyclate Powder is a broad spectrum antibiotic derived from oxytetracycline. Effective against both gram positive and gram negative bacterial ailments, such as Fin & Tail Rot, Septicemia and Mouth Rot. It can also be used concurrently with Erythromycin to treat forms of Columnaris.”

Erythromycin Powder
• “Erythromycin is a common antibiotic used to treat a variety of bacterial ailments.”
• “Treatment Against: Columnaris, Fin and Tail Rot, Popeye and other diseased [sic] caused by Flavobacterium columnare, Haemophilus piscium, Aeromonas punctata, Aeromonas hydrophila, and Cytophaga aquatilis bacteria.”

General Antibiotic Cure
• “General Antibiotic Cure is a blend of pure erythromycin and pure doxycycline hyclate. No fillers to interfere with treatment. This combination has shown to be more effective than using each drug on its own.”
• “Erythromycin is a common antibiotic used to treat a variety of bacterial ailments.”
• “Doxycycline Hyclate is a broad spectrum antibiotic…”
• “Effective against: Both gram positive and gram negative bacterial ailments, such as Columnaris, Fin and Tail Rot, Fin & Tail Rot, Septicemia, Mouth Rot, Popeye and other diseased [sic] caused by Flavobacterium columnare, Haemophilus piscium, Aeromonas punctata, Aeromonas hydrophila, and Cytophaga aquatilis bacteria.”

General Parasite Cure
• “General Parasite Cure is a blend of pure metronidazole and pure praziquantel. No fillers to interfere with treatment. This combination has shown to be more effective than using each drug on its own. Metronidazole is an anti-protozoan medication and praziquantel is a broad spectrum deworming medication.”
• “Effective against Heximata, Malawi bloat, body slime, chilodonella, freshwater ich, epistylis, schistosoma, liver flukes, gill flukes, flat worms, tapeworms and turbelliarians.”

General Trio Powder
• “General Trio Powder is a blend of kanamycin, metronidazole and nitrofurazone. This combination is known as a ‘super cure’ as it covers a wide spectrum of ground. This triple hitting medication is an excellent treatment option when you are unsure what is ailing your fish.”
• “Kanamycin Sulfate is a highly effective broad spectrum antibiotic that targets many bacterial strains and is useful in controlling many bacterial infections, including Aeromonas, Vibrio, Flexibacter and Mycobacteria in both freshwater and saltwater environments.”
• “Metronidazole most often used for its anti-protozoa properties, however it is also good for treating anaerobic bacteria as well. Metronidazole is effective for treating internal and external flagellates as well as protozoan parasites such as Cryptocaryon in marine aquaria or against Hexamita and Ichthyophthirius.”
• “Nitrofurazone is the active ingredient in Furan 2 and is an antibiotic drug that has antiprotozoan properties. It is known to target Columnaris, Flexibacter, Black Molly Disease (Flavobacterium columnaris), Bacterial Gill Disease, Aeromonas, Excess Body Slime, Cloudy Eye, Streptococcus, Furunculosis, Fin and Tail Rot, Marine external ulcer disease and some protozoan infestations. Useful in treating minor topical skin infections of freshwater and marine species.”
• “When these three medications are used concurrently they are referred to as a super drug due to the fact that they have a synergystic effect that makes them even more effective than when used on their own.”

Kanamycin Sulfate
• “Kanamycin Sulfate is a broad spectrum antibiotic that is bacteriocidal for many bacterial strains and is useful in controlling many bacterial infections, including Aeromonas, Vibrio, Flexibacter and Mycobacteria in both freshwater and saltwater environments.. It is also referred to as a super drug when combined with Nitrofurazone and/or Metronidazole as the synergistic properties between these medications are even more effective than when treating with just a single drug.”
• “Treating Tuberculosis: Dose daily for 30 days minimum when treating resistant forms of tuberculosis.”

Metronidazole Powder
• “Metronidazole powder is an antibiotic (for anaerobic bacteria) and anti-protozoa medication used to treat a wide range of conditions internally and externally in fish.”
• Metronidazole has been shown to be highly effective against internal and external flagellates. It is also effective against protozoan parasites such as Cryptocaryon in marine aquaria or against Hexamita and Ichthyophthirius.”
• “Antibacterial Treatment: Metronidazole has proven to be effective against anaerobic bacteria, hence its recommendation as an antibiotic. However, we recommend using in combination with Neomycin, especially when attempting to treat bloat.”
• “Nematode or Trematode Treatment: Metronidazole is effective when used in combination with Praziquantel for internal parasites.”

Neomycin Sulfate Powder
• “Neomycin Sulfate Powder is a second generation antibiotic that targets pseudomonas, tuberculosis, and other gram negative bacteria in both freshwater and saltwater environments.”
• “Treating Tuberculosis: Dose daily for 30 days minimum when treating resistant forms of tuberculosis.”

Nitrofuracin Green
• “Nitrofuracin Green is a blend of Nitrofurazone, Sulfathiazole Sodium, Methylene Blue and Sodium Chloride. This combination is an excellent general treatment. Perfect to use as a preventative with new arrivals while in quarantine. And can be used to prevent ammonia burns while in the shipping bags when fish are properly conditioned for shipment.”
• “Nitrofuracin Green is a wide spectrum product that can treat anti-microbial, antiprotozoa, anti-bacterial and anti-fungal ailments. Helps to heal open wounds and ammonia burn. Widely used to treat shipping water too.”

Nitrofurazone Powder
• “Nitrofurazone is the active ingredient in Furan 2. It is an antibiotic drug that may have anti-protozoan properties. Can be used as a preventative as well as to treat disease.”
• “Effective against Columnaris, Flexibacter, Black Molly Disease (Flavobacterium columnaris), Bacterial Gill Disease, Aeromonas, Excess Body Slime, Cloudy Eye, Streptococcus, Furunculosis, Fin and Tail Rot, Marine external ulcer disease and some protozoan infestations. Useful in treating minor topical skin infections of freshwater and marine species.”
• “General Anti-Parasitic, Fungal and Bacterial Treatment/Preventative: Combine with Kanamycin or Metronidazole as these drugs work well together.”
• “Disinfectant: Excellent disinfectant for a Quarantine Tank with new fish arrivals.”

Oxolinic Acid
• “Oxolinic acid is a hard to find antibacterial medication. It is known as a last chance treatment as it often provides results when other, more common treatments have failed.”
• “Effective Against: Known to be highly effective against resistant aerosomas [sic] and bacterial hemorraghic septecemia which both tend to be deadly if not treated early. Also, effective against tail & fin rot and some columnaris strains.”

Oxytetracycline Hydrochloride Powder
• “Oxytetracycline Hydrochloride Powder is a popular antibiotic due to its ability to treat both gram-positive and gram-negative bacteria. It is commonly used to kill marine ulcer disease, mouth fungus, cold water disease and bacterial hemorrhagic septicimea making it a good all around antibiotic.”
• “Treats: Gram-positive and gram-negative bacteria, such as marine ulcer disease, cold water disease, bacterial hemmorrhagic septicemia and mouth fungus.”

Anti-Parasite Duo Flake
• “The use of medicated foods is the only way to effectively treat internal disease. And under certain conditions using a single drug does not have the desired effect. Our Anti-Parasite Duo Flake combines metronidazole with praziquantel. This drug combination has shown to be more effective than using each drug on its own. Metronidazole is an anti-protozoan medication and praziquantel is a broad spectrum deworming medication. This combination will treat a variety of parasites in the gut. Shown to treat hexamita, Malawi bloat, body slime, chilodonella, freshwater ich, epistylis, schistosoma, liver flukes, gill flukes, flat worms, tape worms and turbellarians.”

Anti-Parasite Duo Pellet, 1 mm
• “The use of medicated foods is the only way to effectively treat internal disease. And under certain conditions using a single drug does not have the desired effect. Our Anti-Parasite Duo Pellet combines metronidazole with praziquantel. This drug combination has shown to be more effective than using each drug on its own.”
• “Metronidazole is an anti-protozoan medication and praziquantel is a broad spectrum deworming medication. This combination will treat a variety of parasites in the gut. Shown to treat hexamita, Malawi bloat, body slime, chilodonella, freshwater ich, epistylis, schistosoma, liver flukes, gill flukes, flat worms, tape worms and turbellarians.”

Antibiotic Duo Flake
• “Antibiotic Duo Flake combines two popular antibiotics to provide a broad spectrum tratment [sic] against both gram positive and gram negative infections. Contains a full dose of erythromycin and doxycycline hyclate. This combination has been shown to be more effective that with treating each drug on its own.”
• “Erythromycin is a common antibiotic used to treat a variety of bacterial ailments.”
• “Doxycycline Hyclate is a broad spectrum antibiotic…”
• “Effective against: Both gram positive and gram negative bacterial ailments, such as Columnaris, Fin and Tail Rot, Fin & Tail Rot, Septicemia, Mouth Rot, Popeye and other diseased [sic] caused by Flavobacterium columnare, Haemophilus piscium, Aeromonas punctata, Aeromonas hydrophila, and Cytophaga aquatilis bacteria.”

Antibiotic Duo Pellet, 1 mm
• “Antibiotic Duo Pellets combine two popular antibiotics to provide a broad spectrum tratment [sic] against both gram positive and gram negative infections. Contains a full dose of erythromycin and doxycycline hyclate. This combination has been shown to be more effective that with treating each drug on its own.”
• “Erythromycin is a common antibiotic used to treat a variety of bacterial ailments.”
• “Effective against: Both gram positive and gram negative bacterial ailments, such as Columnaris, Fin and Tail Rot, Fin & Tail Rot, Septicemia, Mouth Rot, Popeye and other diseased [sic] caused by Flavobacterium columnare, Haemophilus piscium, Aeromonas punctata, Aeromonas hydrophila, and Cytophaga aquatilis bacteria.”

Antibiotic Flake with Doxycycline
• “Antibiotic Flakes with Doxycycline is a must have for the fish medicine cabinet. These antibiotic flakes are used as a broad spectrum antibiotic to treat both gram positive and gram negative bacterial disorders, including Fin and Tail Rot, Septicemia and Mouth Rot.”

Erythromycin Antibiotic Flake
• “Erythromycin Antibiotic Flake is a popular antibiotic that works on a variety of bacterial diseases, including Fin and tail Rot, corynebacterium (a bacteria that causes columnaris), kidney disease and pop eye.”

General Trio Medicated 1mm Pellet
• “This triple hitting medicated pellet is a great general treatment option when you are unsure what is ailing your fish. This medicated food includes three medications to cover a fairly wide spectrum of diseases that target aquarium fish in both freshwater and saltwater environments.”
• “Kanamycin Sulfate is a highly effective broad spectrum antibiotic that targets many bacterial strains and is useful in controlling many bacterial infections, including Aeromonas, Vibrio, Flexibacter and Mycobacteria in both freshwater and saltwater environments.”
• “Metronidazole most often used for its anti-protozoa properties, however it is also good for treating anaerobic bacteria as well. Metronidazole is effective for treating internal and external flagellates as well as protozoan parasites such as Cryptocaryon in marine aquaria or against Hexamita and Ichthyophthirius.”
• “Nitrofurazone is the active ingredient in Furan 2 and is an antibiotic drug that has antiprotozoan properties. It is known to target Columnaris, Flexibacter, Black Molly Disease (Flavobacterium columnaris), Bacterial Gill Disease, Aeromonas, Excess Body Slime, Cloudy Eye, Streptococcus, Furunculosis, Fin and Tail Rot, Marine external ulcer disease and some protozoan infestations. Useful in treating minor topical skin infections of freshwater and marine species.”

General Trio Medicated Flake
• “This triple hitting medicated flake is a great general treatment option when you are unsure what is ailing your fish. This medicated food includes three medications to cover a fairly wide spectrum of diseases that target aquarium fish in both freshwater and saltwater environments.”
• “Kanamycin Sulfate is a highly effective broad spectrum antibiotic that targets many bacterial strains and is useful in controlling many bacterial infections, including Aeromonas, Vibrio, Flexibacter and Mycobacteria in both freshwater and saltwater environments.”
• “Metronidazole most often used for its anti-protozoa properties, however it is also good for treating anaerobic bacteria as well. Metronidazole is effective for treating internal and external flagellates as well as protozoan parasites such as Cryptocaryon in marine aquaria or against Hexamita and Ichthyophthirius.”
• “Nitrofurazone is the active ingredient in Furan 2 and is an antibiotic drug that has antiprotozoan properties. It is known to target Columnaris, Flexibacter, Black Molly Disease (Flavobacterium columnaris), Bacterial Gill Disease, Aeromonas, Excess Body Slime, Cloudy Eye, Streptococcus, Furunculosis, Fin and Tail Rot, Marine external ulcer disease and some protozoan infestations. Useful in treating minor topical skin infections of freshwater and marine species.”

Kanamycin Flake
• “Kanamycin Flake are an excellent choice for medicating both freshwater and saltwater species.”
• “Highly effective against gram negative bacteria, such as septicemia, popeye, fin & tail rot, dropsy, kidney disease as well as resistant tuberculosis. It is also referred to as a super drug when combined with Nitrofurazone and/or Metronidazole as the synergistic properties between these medications are even more effective than when treating with just a single drug.”
• “Treating Tuberculosis: Feed 1-2 times a day for 30 days minimum when treating resistant forms of tuberculosis.”
Kanamycin Pellet
• “Kanamycin Pelletare [sic] an excellent choice for medicating both freshwater and saltwater species.”
• “Highly effective against gram negative bacteria, such as septicemia, popeye, fin & tail rot, dropsy, kidney disease as well as resistant tuberculosis. It is also referred to as a super drug when combined with Nitrofurazone and/or Metronidazole as the synergistic properties between these medications are even more effective than when treating with just a single drug.”
• “Treating Tuberculosis: Feed 1-2 times a day for 30 days minimum when treating resistant forms of tuberculosis.”

Metro Double Flake
• “The use of medicated foods is the only way to effectively treat internal disease. Coupled with elevated heat 86-90F / 30-32C treatment becomes even more effective for treating hemamita [sic].”
• “Metronidazole is an anti-protozoan fish medication used to treat hexamita (hole in the head disease or Malawi bloat), body slime (chilodonella), freshwater ich, epistylis in pond fish.”

Metro Pellet, 1mm
• “The use of medicated foods is the only way to effectively treat internal disease. While treating this product should be the only food source offered to ensure the proper amount of medication is taken in. Additionally, treatment may be coupled with elevated temperatures, such as when treating for hemamita.”
• “Metronidazole is an anti-protozoan fish medication used to treat hexamita (hole in the head disease or Malawi bloat), body slime (chilodonella), freshwater ich, epistylis in pond fish.”

Metronidazole Flake
• “The use of medicated foods is the only way to effectively treat internal disease. We start with our Gourmet Cichlid Flakes, a food most fish devour, and lace them with Metronidazole.”
• “Offer as the only food source to ensure the proper amount of medication is taken in. Additionally, treatment may be coupled with elevated temperatures, such as when treating for hemamita.”
• “Metronidazole is an anti-protozoan fish medication used to treat hexamita (hole in the head disease or Malawi bloat), body slime (chilodonella), freshwater ich, epistylis in pond fish.”

Nitrofurazone Flake
• “To avoid issues using nitrofurazone in a high pH environment, use this medicated food. Nitrofurazone is the active ingredient in Furan 2. It is an antibiotic drug that may have anti-protozoan properties that can also be used as a preventative.”
• “Effective against Columnaris, Flexibacter, Black Molly Disease (Flavobacterium columnaris), Bacterial Gill Disease, Aeromonas, Excess Body Slime, Cloudy Eye, Streptococcus, Furunculosis, Fin and Tail Rot, Marine external ulcer disease and some protozoan infestations. Useful in treating minor topical skin infections of freshwater and marine species.”

Oxolinic Acid Flake
• “Oxolinic acid is a hard to find antibacterial medication. It is known as a last chance treatment as it often provides results when other, more common treatments have failed.”

Based on our review, your products are for use in ornamental aquarium fish species, 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)]. As drugs for minor species, they are considered “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 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]. 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 "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)].

In addition, your pellet and flake products³ are intended to be used as a food; for example, your Chloroquine Pellet product page includes the statement, “Offer as the only food source for 14-21 days as a treatment…” and your Antibiotic Duo Flake product page includes the statement, “Offer as the only food for 10-14 days.” As defined by section 201(w) of the FD&C Act [21 U.S.C. § 321(w)], an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animals is an “animal feed.” To the extent your pellet and flake products are animal feeds that contain unsafe new animal drugs, they are unsafe animal feeds within the meaning of section 512(a)(2) of the FD&C Act [21 U.S.C. § 360b(a)(2)]. Such unsafe animal feeds are adulterated drugs within the meaning of section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].

Finally, to the extent your pellet and flake products are “food,” as defined by section 201(f) of the FD&C Act [21 U.S.C. § 321(f)],1 they are adulterated foods within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)], which states that a food is adulterated if it bears or contains a new animal drug that is unsafe within the meaning of section 512 of the FD&C Act. As noted above, your products contain unsafe new animal drugs within the meaning of section 512(a) of the FD&C Act. Introduction of an adulterated food 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 products. 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 address this matter may lead to legal action without further notice, including, without limitation, seizure and injunction. You should notify this office, via e-mail, within the following timeframes, of the steps you are taking to correct any violations: Chloroquine Powder, Chloroquine Flake, and Chloroquine Pellets within two (2) working days of the receipt of this letter, all other products within fifteen (15) working days of the receipt of this letter. 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 the above timeframes, state the reason for the delay and the time frame within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, please provide us with your reasoning and any supporting information for our consideration.

Your response should be sent via e-mail to Dr. Vic Boddie at [email protected]. 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

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1 Neomycin Sulfate Powder, Doxycycline Hyclate, Erythromycin Powder, General Antibiotic Cure, General Parasite Cure, General Trio Powder, Kanamycin Sulfate, Metronidazole Powder, Nitrofuracin Green, Nitrofurazone Powder, Oxolinic Acid, Oxytetracycline Hydrochloride Powder, Anti-Parasite Duo Flake, Anti-Parasite Duo Pellet, 1 mm, Antibiotic Duo Flake, Antibiotic Duo Pellet, 1 mm, Antibiotic Flake with Doxycycline, Erythromycin Antibiotic Flake, General Trio Medicated 1mm Pellet, General Trio Medicated Flake, Kanamycin Flake, Kanamycin Pellet, Metro Double Flake, Metro Pellet, 1mm, Metronidazole Flake, Nitrofurazone Flake, and Oxolinic Acid Flake. FDA observed other unapproved new animal drugs, unsafe animal feed, or animal food containing unapproved new animal drugs offered for sale on your website. The products listed in this letter are intended to be examples that are illustrative of FDA’s concerns regarding your products.

2 Chloroquine Pellet, Chloroquine Flake, and Chloroquine Phosphate Powder. In addition, your “Chloroquine Flake” product is included as one of several components within your “Medicine Cabinet” product kit.

3 Some of these products are: Chloroquine Pellet, Chloroquine Flake, Anti-Parasite Duo Flake, Anti-Parasite Duo Pellet, 1 mm, Antibiotic Duo Flake, Antibiotic Duo Pellet, 1 mm, Antibiotic Flake with Doxycycline, Erythromycin Antibiotic Flake, General Trio Medicated 1mm Pellet, General Trio Medicated Flake, Kanamycin Flake, Kanamycin Pellet, Metro Double Flake, Metro Pellet, 1mm, Metronidazole Flake, Nitrofurazone Flake, and Oxolinic Acid Flake.