Prop 65: NPA responds to language of proposed Article 6 changes with ‘significant concerns’

By Adi Menayang

- Last updated on GMT

Related tags Natural products association Proposal

Photo: iStock
Photo: iStock
The Natural Products Association said in a release that the new Article 6 of California’s Prop 65 would “limit consumer access, cost jobs, and harm the economy.”

A repeal has been proposed to Article 6 of California’s Proposition 65, which affects the way products are labelled.

The state’s Office of Environmental Health Hazard Assessment (OEHHA)​ proposed to adopt new regulations​ in Article 6 to provide “more specific guidance on the content of safe harbor warnings for a variety of exposure situations,”​ and methods for providing those warnings. The office argues that it “would further the ‘right-to-know’ purposes of the statute.”

“The regulatory proposal also provides more clarity to the warning requirements and more specificity regarding the minimum elements for providing a “clear and reasonable” warning for exposures that occur from products, including foods, and exposures that occur in various environmental settings,”​ OEHHA said on its website​.

The Natural Products Association (NPA) isn’t happy, especially with the proposal’s language and clarity. “From their draft proposal, it is not clear whether you can actually transmit warnings via labeling as opposed to just the label,”​ Daniel Fabricant, Executive Director of NPA, told NutraIngredients-USA. “Some private enforcers think that labeling should never be allowed as a means of transmitting warning statements because labeling can include so many different things like websites, brochures, pamphlets, package insert, and other printed material sold or provided with the purchased consumer good.”

A costly change?

According to OEHHA, there won’t be any “significant cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action,” ​but they don’t expand on providing numbers.

“FDA provides an economic impact analysis with every final rule and guidance they submit,” ​Dr. Fabricant said. “It is par for the course for a regulatory agency, it is expected, and it should be a requirement of a regulatory agency. For dietary supplement firms across the US to change their labels, FDA estimated between a $143M and $460M hit to the industry. If this proposed draft is accepted, all products must be relabeled to include one or more chemicals which the warning statement pertains to.”

Communication between NPA and OEHHA has been an ongoing matter. The most recent comment​ from NPA to OEHHA was issued this week. “In total we have sent in 8 comments over the past 18 months,”​ Dr. Fabricant said. “They took our suggestion and defined what a food was, but they have left out so many issues we have brought up in the past, probably the most important of which is an economic cost analysis to the consumer and California firms.”

As of press time, NutraIngredients-USA is still waiting for a comment from OEHHA.

Related topics Regulation GMPs, QA & QC Adulteration

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