At FDA Compliance Simplified, we focus on Food and Drug Administration regulations that cover a wide variety of products used in and on the bodies of humans and animals. However, no product is regulated by only one governing authority. At the federal level, all products are also subject to Federal Trade Commission rules on advertising, and some FDA-regulated products are also subject to Environmental Protection Agency, or US Department of Agriculture regulations.
But it is not just the Feds that consumer product companies need to be aware of. We are seeing more and more states pass laws that affect how products must be labeled and how they may be sold. One longstanding state law that affects FDA regulated products is California’s Prop 65, which we covered in a post a few years back.
My team and I make a point of alerting clients to Prop 65 requirements but it seems that not everyone pays attention. Prop 65 can cause problems even for very small companies because it can be enforced by private citizens and not just by government authorities. These citizen-enforcers are commonly referred to as “bounty hunters” because they receive 25% of the penalties recovered by their actions.
Keller & Heckman recently published an article tallying Prop 65 bounty hunter notices filed in July of 2024. If you distribute products in California, it will be worth your time to take a look at the type of products and the claims covered by the 489 notices filed in just one month, even though only 302 were directed against FDA-regulated products.
Knowledge is power. Be aware of your regulatory risks so that you will be able to protect your business. Contact us for help.
