FDA WARNING_LETTER - savvy holistic health - August 31, 2020

Record Details

The FDA issued a Warning Letter to Holistic Healthy Pet on August 25, 2020, following a review of their website (www.holistichealthypet.com) in July and August 2020. The review identified several products marketed with claims establishing them as drugs under section 201(g)(1)(B) of the FD&C Act, intended for disease diagnosis, cure, mitigation, treatment, or prevention in animals.

The products cited as unapproved new animal drugs include: Doctor’s Best for Your Pets - Bee Propolis, Savvy Holistic Health Pet Essences - Calming Comfort, various Holistic Animal Remedies (HAMPL)/HAMPL Pet Formulas (AN008, AN013(A), AN013(D), AN165, AN167, AN169, AN177, AN183(A), AN206, AN231, AN287, AN312), Calm My Pet - Calming Essence: Calm My Arthritis, and Glacier Peak Holistics - Inflapotion Capsules.

Examples of drug claims include "antibiotic" for Bee Propolis, "seizures" for AN008, "cancer" for AN013(A) and AN013(D), "Canine Distemper Virus" for AN165, "Heartworm" for AN1

Company: savvy holistic health
Inspection Date: August 31, 2020
Product Type: Veterinary
Office: Center for Veterinary Medicine
Person: Amber Mccoig (Senior Veterinary Medical Officer)

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ID · 7fe2a401-a3b1-48fa-90ff-8ac0b62ff6e2

Violation Codes10

21 U.S.C. 331(a)21 U.S.C. 321(v)21 U.S.C. 360b21 U.S.C. 360ccc21 U.S.C. 360ccc-121 U.S.C. 360b(a)21 U.S.C. 351(a)(5)FD&C Act 201(g)(1)(B)FD&C Act 512FD&C Act 571

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