FDA Issues Statement Supporting the Exemption of Coffee from Prop. 65 Warning Requirements

The U.S FDA has issued a formal Statement from FDA Commissioner Scott Gottlieb that supports exempting coffee from Prop. 65 warning requirements.

In June, the Superior Court for the County of Los Angeles issued a decision that requires certain ready-to-drink coffee products sold in California to provide compliant Prop. 65 warnings based on the presence of acrylamide.  Immediately following the Court’s decision was rendered, OEHHA issued a draft regulation that, if adopted, would mean that no Prop. 65 cancer warning would be required for coffee.  OEHHA originally added acrylamide to the Prop. 65 List in 1990 as a carcinogen. The agency subsequently listed Acrylamide in 2011, after it determined that the chemical causes both developmental and male reproductive toxicity.

Acrylamide forms in certain plant-based foods such as coffee beans, potatoes, and bread products when they are cooked or roasted under high temperatures.  The original listing of acrylamide was based on its use in industrial applications such as the processing of grouting material.  Swedish scientists discovered the Maillard reaction. The chemical reaction that causes the formation of acrylamide in starchy foods in 2002.

FDA said in its statement that it is “deeply concerned” with the Superior Court’s decision and believes that “requiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them.”  Instead, “Strong and consistent evidence shows that in healthy adults’ moderate coffee consumption is not associated with an increased risk of major chronic diseases, such as cancer, or premature death, and some evidence suggests that coffee consumption may decrease the risk of certain cancers.”

In addition, the FDA took the unprecedented step of “strongly supporting” OEHHA’s related proposal to issue a new regulation to help clarify that Prop. 65 cancer warnings are not required for coffee products because the Agency has determined that brewed coffee poses no significant risk of cancer.  Although FDA’s statement has no legal effect on the Superior Court’s decision, the agency’s’ statement provides some indication that FDA may be more inclined to provide guidance or take positions on certain food items, such as it did recently in providing input about federal interests in breakfast cereals.

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