Marketers of consumer products, including foods, beverages, dietary supplements, OTC drugs, and cosmetics, should be evaluating their products, including product packaging, for the presence of bisphenol A (BPA) without delay. On May 12, 2016, the one-year grace period permitted by California’s Office of Environmental Health Hazard Assessment (OEHHA) ends, and companies whose products expose California consumers to BPA must provide a Proposition 65 (Prop 65) reproductive toxicity warning to those consumers.

Importantly, California has not yet established a maximum allowable dose level (MADL) (i.e., a safe harbor level) for BPA, so a product that exposes consumers to any amount of BPA will be required to carry a warning for reproductive toxicity in females unless the company marketing the product has established an MADL in compliance with California regulations. As a reminder, Proposition 65 requires “clear and reasonable” warnings prior to exposure.

While a number of companies have already moved away from the use of BPA, the chemical still appears to be widely used in thermal receipt paper and in the coatings on the inside of many food and beverage cans. BPA is also used in the production of polycarbonate plastic. In that regard, some, but not all, plastics that are marked with the resin identification code 7 may be made with BPA.

For newly listed chemicals, it is common to see a flood of notices of violation and subsequent lawsuits at the end of the twelve-month grace period. Accordingly, it is very important to ensure compliance by May 12, 2016 if your products expose California consumers to any amount of BPA.

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Claudia A. Lewis

Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians…

Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians, nutritionists, healthcare associations, and citizen groups. She has also aided international clients in establishing a U.S. market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA).

Todd A. Harrison

Todd Harrison, co-chair of Venable’s FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. Working extensively in the areas of food and dietary supplement safety, labeling, and advertising claims, Todd helps clients in the consumer…

Todd Harrison, co-chair of Venable’s FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. Working extensively in the areas of food and dietary supplement safety, labeling, and advertising claims, Todd helps clients in the consumer products, drug and medical device, and dietary products industries comply with government regulations. He regularly achieves favorable results in defending clients against Federal Trade Commission (FTC) advertising complaints, enforcement actions, and prosecutions, and overcoming competitor challenges in courts and other fora.