All U.S. states have departments of health and departments of agriculture. These agencies run parallel to the federal Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA).
With few exceptions (such as animal food registration), and for constitutional reasons, these states’ laws are remarkably similar to federal regulations. However, while laws at the state and federal levels are similar, the means of enforcing can be quite different.
State agencies are much smaller, but their enforcement actions can be more severe – sometimes levying heavy fines, directly taking possession of allegedly non-compliant product, or even, in the case of Proposition 65 (Prop 65), enabling private party lawsuits for the most minor of violations.
Successfully navigating state issues requires the advice of a person with experience in both state and federal agencies.
The California Department of Public Health (CDPH) Food and Drug Branch enforces the Sherman Law, which strongly resembles FDA law. They regulate FDA products such as foods, cosmetics, supplements, drugs, and medical devices.
The CDPH’s Cannabis Safety Branch regulates marijuana, which is now legal in California but still illegal under federal FDA and the Drug Enforcement Administration (DEA) law.
The California Department of Food and Agriculture (CDFA) regulates farms in California, but also has jurisdiction over organic products, animal feed, and marijuana cultivation.
Companies operating or shipping regulated product in California (or any other state) should find expert assistance to ensure you are complying with state laws and regulations.
Prop 65 requires that products sold in California must bear specific warnings if the product will expose consumers to chemicals known to the State of California to cause birth defects or cancer. The California Office of Environmental Health Hazard Assessment (OEHHA) maintains a list of such chemicals.
The chemicals run from abstruse processing chemicals to common food color additives (4-MEI in caramel color), alcohols, cosmetic ingredients, FDA-cleared product liners, and EPA approved pesticides.
First, many companies do not know that they have Prop 65 chemicals in them, because some of the chemicals are not added but either naturally occurring (e.g., lead in tea) or come from common processing (e.g., 4-MEI from roasting caramel).
Second, Prop 65 is dangerous because California law allows for private enforcement. Thus, any individual (or ambitious attorney) can sue for significant damages and attorney fees. Finally, Prop 65 applies to all product sold in California, which exposes companies from across the U.S. and around the world to potential lawsuits.
We can help you if you’re facing a state enforcement action, attempting to enter the California marijuana, organic product, or animal food markets, or simply fearful about Prop 65. We will promptly evaluate your case and provide a quote.
Then we will help you develop a plan to overcome any state level challenges. We have extensive experience in California law as well as nationwide regulatory policy. Access to this kind of experience-based advice can make the difference between success and failure. Contact us today for a free consultation.
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