WARNING LETTER
New Life International
MARCS-CMS 609499 —
July 21, 2020
Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Mr. Pablo Tepoot
New Life International
31950 SW 197 Ave
Homestead
,
FL
33030
United States
sales@nlsfishfood.com
ptepoot@ix.netcom.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
Date: July 21, 2020
RE: Unapproved Chloroquine Phosphate Product
RE: [609499]
Dear Mr. Pablo Tepoot:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address http://nlsfishfood.com/ in May 2020 and July 2020. The FDA has observed that your website offers New Life Spectrum Ick•Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets 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. § 321(a)].)
Your New Life Spectrum Ick•Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets 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. The labels for both products identify the active ingredient as I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl (chloroquine phosphate).
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 Ick•Shield Bath Solution Powder and Ick•Shield Pellets:
• “Combats Aquarium Ectoparasites”
On your “Spectrum” page:
• “Spectrum’s line of medicated foods and water treatment baths. Ick•Shield is designed to combat both marine and freshwater Ich and parasites more safely than copper.”
On your “Fish Disease Database” page for “Freshwater ICH”:
• “New Life Spectrum® IckSHIELD pellets can attack the parasite while in the trophont stage while infesting the fish. IckSHIELD powder water treatment bath solution can kill both the trophont and free-swimming tomite stages.”
On your product page for “Ick•Shield Pellets”:
• “The treatment is not effective if fish are not eating the pellets. For fish that are not eating, Ick•Shield Bath Solution Powder is the preferred treatment.”
• “Ick•Shield fed to newly acquired fish kept in a quarantine tank for the full treatment cycle is recommended for prevention and to reduce the likelihood of outbreaks in you [sic] reef tank.”
• “Even fish not showing symptoms may be treated in a quarantine tank prior to introduction in the tank. Use the full treatment.”
New Life Spectrum Ick•Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets are 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 New Life Spectrum Ick•Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets 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. New Life Spectrum Ick Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets 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)].
Your “Spectrum” page represents your Ick•Shield Pellets as a “medicated food.” The label for your New Life Spectrum Ick•Shield Pellets identifies “I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl,” the chemical name for chloroquine phosphate, as the “Active Ingredient” in this product, which the label indicates “attacks a variety of ecotoparasites” and “[c]an help disrupt damaging feeding stage of ick-causing parasite lifecycle.” Labeling further states, “The full treatment cycle is needed to disrupt the parasite lifecycle and reduce chances of a new outbreak.” I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl is a new animal drug under section 201(v) of the FD&C Act. It has not been approved, conditionally approved, or index listed for use in ornamental fish. Therefore, I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl is an unsafe new animal drug within the meaning of section 512(a) of the FD&C Act.
The label for your New Life Spectrum Ick•Shield Pellets describes the product as “high-concentration nutrition that supports fish health.” The label lists nutritional ingredients, such as krill and flour, and provides an animal food guaranteed analysis. Furthermore, the label notes that your product has a “highly palatable taste [that] enourages fish to eat.” Labeling indicates that fish should be fed twice daily for either ten or 21 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 New Life Spectrum Ick•Shield Pellets product is an animal feed that contains the unsafe new animal drug I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl, it is an unsafe animal feed within the meaning of section 512(a)(2) of the FD&C Act [21 § U.S.C. 360b(a)(2)]. Such an unsafe animal feed is an adulterated drug within the meaning of section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
Finally, your New Life Spectrum Ick•Shield Pellets are a “food,” as defined by section 201(f) of the FD&C Act [21 U.S.C. § 321(f)], and they are an adulterated food 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, I,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-NI, NI-diethyl is an unsafe new animal drug 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.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s regulations.
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.
Within 48 hours, please send an email to the contact person below,
describing the specific steps you have taken to correct these 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 do not believe that your products are 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:
08/04/2020
Regulated Product(s)
Animal & Veterinary
Drugs