Latest Prop 65 Draft Leaves “Room for Improvement,” Says AHPA

In the continuing effort to improve the cumbersome Proposition 65 warning label regulations, California’s Office of Environmental Health Hazard Assessment (OEHHA) recently unveiled a second draft of regulatory language amendments. Although the latest draft includes several recommendations made by the American Herbal Products Association (AHPA; Silver Spring, MD), Michael McGuffin, president, believes the revisions still don’t go far enough.

One of AHPA’s most significant recommendations that went unheeded in this draft is the idea of providing another labeling option aimed at specific populations, such as children, pregnant or nursing women, or men or women who are trying to conceive, according to McGuffin. For instance, instead of a Prop 65 label that says a product contains chemicals “known to the State of California to cause birth defects or other reproductive harm,” AHPA proposes an optional warning for certain products that reads, ”WARNING: Not for use by children or nursing women.”

“We think that would accomplish numerous things,” says McGuffin. “One is that it’s clearer. It’s a clear instruction. The other is that it’s less inflammatory. I don’t know why we would need to say ‘birth defects’ on our bottles if we say ‘don’t choose it if you’re pregnant.’ The third is I frankly think we would have better compliance if companies knew that they had an option that didn’t brand their products as carcinogens and agents of reproductive harm. It would also be more accurate.”

There were, however, several of AHPA’s recommendations that were incorporated in the latest draft regulatory language. An earlier proposal to require the international health hazard symbol on warning labels was dropped because it would cause “unwarranted alarm,” and a previous proposal that companies submit information about hazardous chemicals to OEHHA for online posting was also dropped, AHPA said. These were both AHPA recommendations, as well as the recommendation that dietary supplements be included under the definition of food, which was also included in the draft, according to AHPA’s press release.

Despite these changes, McGuffin “[doesn’t] believe this proposed revision will end up with the best information for consumers.” He says one of the greatest challenges is communicating to consumers that just because a product contains trace amounts of a chemical that the state of California has deemed harmful, it does not mean the product itself will cause cancer. He refers to it as “truthful but misleading.” In McGuffin’s opinion, the draft revisions have not proposed an adequate solution to remedy this.

Although McGuffin doesn’t see bounty hunter lawsuits being reduced under the latest draft regulatory language, he expects manufacturers would find the labeling process under the latest draft fairly similar to how it is now.

“I don’t believe we’ll see an increased burden, but I don’t think that manufacturers should relax yet. Let’s keep trying to work to create a decreased burden,” says McGuffin. “We want the burden shifted to where we can provide accurate information, instead of what we think is inaccurate information.”

This second draft of revisions follows a pre-regulatory proposal OEHHA released last March. Other changes in the draft amendment include mandating a new warning language and symbol system, requiring 12 chemicals or groups of chemicals be specifically identified by name on warnings, not grandfathering any previously approved warnings, and delineating additional warning requirements for a variety of specific products and locations. OEHHA will accept comments on the latest revisions until April 8, 2015.

“Between the pre-regulatory proposal and this, which is the proposal, there were significant changes made, and we think that’s because they listened to the comments,” said McGuffin. “They didn’t accept all of it, but they made significant changes. I don’t believe OEHHA thinks this is the final draft. I think they really will continue to listen.”

McGuffin says AHPA will continue to advocate for labeling that’s directed at specific populations and will submit additional and reiterative comments to OEHHA.  He expects the remainder of the process to move fairly quickly, possibly with a final draft released by the end of the year.

Read more:

Prop 65 Expert Q & A

Michael Crane
Associate Editor
Nutritional Outlook magazine
michael.crane@ubm.com

Photo © iStockphoto.com/BanksPhotos