California Seeks to Limit Access to Supplements

Trenton, NJ—The New Jersey State Legislature recently passed the New Jersey Assembly Bill 4133, which allows physicians and podiatric physicians to dispense certain dietary supplements. The bill was originally introduced in the NJ state assembly in February 2015, and passed the state senate on January 19 of this year.

Just prior to its passing, the Council for Responsible Nutrition sent a letter the NJ Governor Chris Christie praising his for the passage of this “forward-thinking legislation,” which focuses on “promoting a healthcare vs. sickcare system.”

Meanwhile, a proposal by the California Office of Environmental Health Hazard Assessment (OEHHA) could limit consumer access to dietary supplements and other natural products. The OEHHA is currently considering making changes to the way certain products, including dietary supplements and other natural products, are labeled in the State of California.

The proposed “Article 6, Clear and Reasonable Warnings” was intended to revamp Proposition 65 in an effort to stop frivolous lawsuits and improve consumer safety. But the language in Article 6 has certain groups worried.

“This proposal would be a boon for trial lawyers at the cost of consumers, small businesses and the economy,” said Daniel Fabricant, Ph.D., executive director and CEO of Natural Products Association. “NPA strongly encourages regulators to consider the negative unintended consequences this rule could have on consumers and the overall business climate in California.”

NPA believes the following issues are problematic with Article 6:

  • OEHHA is no longer requiring that warnings state the name of one or more of 12 chemicals identified by OEHHA. This creates too much ambiguity, says NPA.
  • Companies would be burdened with showing that a warning is required, not the state of California.
  • The term “labeling” is not clearly defined, and NPA believes it should be in line with that in the Federal Food Drug and Cosmetic Act.
  • NPA also feels OEHHA should clarify its requirement for issuing warnings in foreign languages.
  • NPA believes the proposition is overly burdensome on e-tailers, since warning statements must be given before purchases, even if the product is already labeled.

In a letter to OEHHA, NPA stated, “NPA believes the proposed new Article 6 will result in tremendous financial and resource challenges to businesses and will have the potential to create more compliance pitfalls resulting in a glut of new threatened or actual litigation.”

The American Herbal Products Association (AHPA's) also has problems with the draft, noting that "almost none of the recommendations previously submitted by AHPA and others seeking reasonable regulation were accepted in the agency's current draft."

AHPA's letter to the OEHHA raised several other concerns, bullet pointing several places where alternative warning language for the term "reproductive toxicity" could be used. AHPA also felt that the OEHHA's definition of "signs" was problematic and is concerned about the allowance of a single company or brand to request the agency adopt a warning method for an entire product category.

Published in WholeFoods Magazine Online 2/1/2016