Confusion abounds over what CA AB 899 may mean for baby supplements

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The legislation, originally interpreted to be applicable to baby foods, may now encompass dietary supplements, leaving companies scrambling to understand their obligations.

California Assembly Bill 899 requires manufacturers of baby food to test samples for toxic elements (arsenic, cadmium, lead and mercury) at least once per month. Manufacturers must provide test results to authorized department agents and provide information disclosures to consumers on their websites.

AB 899 was signed into law by Governor Gavin Newsom (D) on Oct. 11, 2023. The bill stated that any baby food products sold or made in California will require testing for specific toxic elements beginning Jan. 1, 2024. The heavy metal disclosure requirements went into effect Jan. 1, 2025.

This week, manufacturers must now disclose on their website the following for baby food products sold, manufactured, delivered, held or offered for sale in the California:

  • The name and level of the toxic elements (arsenic, cadmium, lead and mercury) present in each production aggregate of their final baby food product.
  • Descriptive information (e.g., product name, universal product code, size, lot numbers or batch numbers) to enable accurate identification of the final baby food product by consumers.

Last minute ‘clarification’

Until recently, AB 899 was thought to impact only baby food sold in California that is marketed for children under the age of two. However, in late November, the California Department of Health clarified that the bill also includes dietary supplements, leaving nutraceutical brands clambering for guidance on how to implement the new requirements in a matter of weeks.

Loren Israelsen, founder and presidnent of the United Natural Products Alliance, said that he has been in communication with the California Health Department in recent weeks to try and make sense of the bill.

“I have written to the department twice and said, so how does it work now for DS? First of all, we’re not convinced that supplements were intended to be included by the authors of this legislation in California,” he said.

“The definition of food in California is a little different than the federal definition, and there is now an open debate whether or not California can legally require supplements to be included under their definition of food, so that may end up being litigated early next year.

So that’s problem one. Problem two is what are some of the companies supposed to do on virtually no notice. They can’t possibly come into compliance on Jan. 1.”

Israelsen added that at this point he has more questions than answers, noting that the California’s Department of Health has been slow to respond and nonchalant when it does.

“I also said, by the way, there is nothing on your website,” he said. “We had a webinar on this and our members went and looked at the California website trying to get details. They can’t find anything, and in fact, it’s not there. And so the response from California was, ‘well, yeah, it’s the holidays and we’ll do it first thing next year.’ So after it’s effective, basically, you’re going to give us some sense of how this is supposed to work?”

Vagaries and mystery

“I’m baffled, I’m really baffled at how the state, just the whole process, their reasoning, not discussing it, providing no notice,” Israelsen said. “And now we ask, and we’re trying to get some substantive answers. We’re really not getting much, so that’s where we are. It’s really kind of a Kafkaesque moment here.”

Israelsen said the lack of clarity is leaving him in a tricky situation, unsure of how to properly advise companies.

“On one hand, it would be a lot of work, obviously, if you have products, you now have to go into rapid testing. Well, do you? Since we really don’t understand what we’re supposed to do, and it’s now the holidays, you can’t really begin any meaningful testing program,” he said. “It ought to be discussed within the company and decide, is this something where we need to join a litigation group to formally raise these issues?”

He added that the issue at hand comes down to whether the two sponsors of the bill, Assemblymember Al Muratsuchi and Senator Akilah Weber, originally intended to include supplements in the bill. Israelsen is convinced they did not.

“If the sponsors had wanted dietary supplements to be included, they easily could have explicitly just added those two words,” he said. “So all the way around, there’s just vagaries and mystery about how this came to be and the situation we find ourselves in.”

Speaking to NutraIngredients-USA, Jaclyn Bowen, executive director at Clean Label Project, commented that food brands have had well over a year to prepare for the new requirements.

“We’ve been actively involved since the regulation passed in 2023,” she said. “We’ve had a pretty good working relationship with Assemblymember Al Muratsuchi, the author of the program, as well as his legislative aides have been pretty helpful in terms of providing guidance and feedback. But this latest clarification around inclusion of dietary supplements is definitely something that’s happening at the 11th hour.”

New Year, new clarification?

With AB 899 now in effect, Israelsen hopes the bill’s sponsors and California’s Department of Health can get on the same page and come to an agreement on where supplements sit.

“If it turns out that they say supplements are included, we would reserve the right to challenge that in court if we think that they really don’t, that they have misinterpreted the definition of food in California as it relates to dietary supplements,” he said.

No phase-in period

So far, the California Health Department has not updated its website with any new information since the regulation has gone into effect.

“California AB 899 explicitly defines ‘baby food’ as food for children under two years old packaged in jars, pouches, tubs or boxes, and CRN does not believe dietary supplements are included in the scope of this law,” said Jeff Ventura, vice president, communications at the Council for Responsible Nutrition (CRN).

“However, the California Department of Public Health (CDPH) has indicated a broader interpretation that could encompass some supplements. There is no specific phase-in period proposed for dietary supplements, as the law was not written with them in mind, but companies that manufacture supplements for babies are generally already testing for toxic elements like heavy metals as part of Good Manufacturing Practices (GMPs).”

At the time of publishing, the California Health Department did not respond to email or phone call inquiries.