FDA Crackdown on Animal Product Seizure Claims

Amazon compliance still needs improving

Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites.

You may be saying, “These companies should have known better,” and I agree, but what was bewildering is that three of these companies were cited for seizure-type claims on Amazon. This is surprising because these types of statements on a human supplement lead to delisting, but these letters have highlighted Amazon’s lack of enforcement in the nuanced animal “supplement” arena. I expect animal products making unallowable disease claims on Amazon to be delisted soon, as Amazon tends to be reactive when FDA warning letters are issued. For companies in the animal supplement space, working with the National Animal Supplement Council is a great path towards product compliance, and Apex Compliance, my marketing claims and compliance software product, is proud to be an NASC preferred supplier.

• From one of the warning letters. Yes, the name of the product is Epilepsy & Seizure Formula. “From your product webpage …” on Amazon… • “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”

Homeopathics: One of the warning letters included claims made about homepathics. This is an important reminder that FDA does not tolerate extreme disease claims made about homeopathic products. Here is my previous post about this. 

YouTube: One of the letters includes claims on YouTube. A new Apex Compliance feature allows you to scan entire YouTube channels for keywords and disease claims. This helps find issues before they lead to regulatory trouble. I love it!

For those who are confused about what claims can be made about animal “supplements,” the answer is “not much.” This is because FDA takes a stricter approach against animal supplements compared to human supplements.

Here are some differences in human and animal product claims enforcement with the caveat that all claims must be substantiated.

• Lower-risk structure-function claims like “joint support” are unlikely to attract warning letters in animal or human product marketing.
• Claims that push the compliance boundaries, like “reduces anxious feelings,” may attract an animal product warning letter but are unlikely to be the sole reason for a human product letter. This is because the FDA has a lower “tolerance” for these types of statements in animal products. I write about this in the following posts:
  • Animal Product Testimonials Lead to Warning Letter
  • Animal Product Claims Under Increased Scrutiny
    

Here are the six FDA warning letters.

• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolution-pets-llc-696281-11122024
• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutrition-strength-ltd-696350-11122024
• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/energetic-essences-llc-dba-pet-essences-696395-11122024
• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/veterinary-select-formula-dba-allergic-pet-696354-11122024
• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024
• https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hdfrenchies-llc-dba-bully-baum-696351-11122024