New Life International – FDA Warning Letter, Jul 31, 2020

The FDA issued a Warning Letter to Mr. Pablo Tepoot regarding the sale of New Life Spectrum Ick•Shield Bath Solution Powder and New Life Spectrum Ick•Shield Pellets on http://nlsfishfood.com/. The FDA reviewed the website and product labels in May and July 2020.

The products are deemed adulterated under Section 301(a) of the FD&C Act. They are classified as drugs under Section 201(g)(1)(B) due to claims like "Combats Aquarium Ectoparasites" and "combat both marine and freshwater Ich and parasites." The active ingredient, chloroquine phosphate, is intended for use in fish, a "minor species."

These products are unapproved new animal drugs under Section 201(v) because they lack FDA approval, conditional approval, or index listing, making them "unsafe" and "adulterated" under Sections 512(a) and 501(a)(5).

Furthermore, New Life Spectrum Ick•Shield Pellets are considered an "animal feed" under Section 201(w) and an "adulterated drug" under Section 501(a)(6) because they contain an unsafe new animal drug. They are also an "adulterated food" under Section 402(a)(2)(C)(ii) for the same reason.

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