FDA WARNING_LETTER - savvy holistic health - August 31, 2020
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
ID · 7fe2a401-a3b1-48fa-90ff-8ac0b62ff6e2
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.