Will Dietary Supplements and Functional Foods Carry Prop 65 Warnings?

March 31, 2008

On March 21, 2008, the California EPA Office of Environmental Health Hazard Assessment (“OEHHA”) announced a workshop scheduled for April 18, 2008 to seek public input on the potential regulation of nutrients, such as vitamins and minerals, under Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code § 25249.5, et. seq.). Proposition 65 requires that the state publish and maintain a list of chemicals known to cause cancer or birth defects or other reproductive harm. The list now includes approximately 775 chemicals. If a chemical is on the list, then a product that contains that chemical must carry a specified warning statement unless the exposure poses no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. If exposure falls below OEHHA’s “safe harbor number” for that chemical, then no warning is required.

OEHHA’s workshop announcement states that “certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops,” but that “[e]xcessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects.”  OEHHA asserts that it is “seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods.”

OEHHA has drafted language for a possible regulation. That language would exempt from the definition of “exposure” the consumption of a listed chemical in food if the person “causing the exposure” can show that the chemical is a nutrient that is “beneficial to human health,” and that the total amount of the chemical consumed in a food does not exceed the Recommended Daily Allowance (“RDA”) established by the Food and Nutrition Board of the Institute of Medicine (“IOM”).  If no RDA is established, then the total amount cannot exceed 20% of the Tolerable Upper Intake established by the IOM. A chemical would be considered “beneficial to human health” only if a daily value or allowance has been established by the IOM.

At least three points are notable about OEHHA’s proposal. First is the use of RDA’s as thresholds for determining whether an “exposure” has occurred. This is, to say the least, a novel use of RDA’s. Second is the notion that a nutrient is “beneficial to human health” only if a daily value or allowance has been established by the IOM. What of nutrients that have clearly established health benefits but have yet to make it into IOM’s Dietary Reference Intake Tables? Finally, there is the prospect that dietary supplements and conventional foods that comply with the applicable safety standards and labeling requirements in the Federal Food, Drug, and Cosmetic Act will nonetheless be made to bear a warning label in the state of California.

In a limited sense, California is not breaking new ground. Vitamin A already is included in the Proposition 65 list of chemicals. But the potential breadth of OEHHA’s proposal is such that it is impossible to not recall the long and painful history of FDA’s attempts to regulate the sale of articles containing “excessive” levels of vitamins and minerals. Decades of aborted rulemakings, protracted litigation, and legislative activity resulted in FDA’s virtual retreat from a playing field that proved formidably hostile. It’s hard to imagine that OEHHA has any interest in a reprisal of that experience – the state agency is prudently “requesting input from stakeholders in the enforcement and business communities, as well as other members of the public, concerning issues that may arise if OEHHA proceeds with such a regulatory proposal.” No doubt, OEHHA will get an earful. 

By Ricardo Carvajal, A. Wes Siegner, and Brian J. Donato

Categories: Dietary Supplements |  Foods