Proposed Prop 65 Regulation Changes Based On Faulty Science, Groups Say

The American Herbal Products Association and the Council for Responsible Nutrition say proposed changes regarding California's Proposition 65 regulation rely on faulty science and would be unfair to supplement firms.

The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment announced in April it would hold a meeting to gather input from stakeholders on proposed changes to Prop 65 (¹ 'The Tan Sheet' April 14, 2008, In Brief).

In its proposal, OEHHA says a warning label should be placed on all beneficial nutrients also listed by California to cause cancer or reproductive harm. In addition, the regulation would use recommended daily allowances and upper levels to determine safe levels of nutrients.

In May 2 comments to OEHHA, both AHPA and CRN argue against the use of RDAs and ULs in determining safe nutrient levels.

CRN says the proposal "blurs the distinction between essential and beneficial nutrients on the one hand and arbitrarily assigned values for what constitutes an exposure on the other without regard to relevant risk assessment data."

"The proposed quantitative thresholds [for determining safety] are scientifically invalid, unnecessarily restrictive, and internally inconsistent," the trade group adds.

CRN says RDAs and daily values for nutrients are "unrelated to safety, and thus are invalid" as Prop 65 labeling thresholds. In addition, the proposed safety threshold of 20 percent of the UL is an "arbitrary" determination and creates "conservative and overly restrictive values for some nutrients," CRN says.

Regardless of whether OEHAA uses RDAs and ULs to determine safe nutrient levels, AHPA says it is "unacceptable to limit the definition of nutrients 'beneficial to human health' to only those nutrients with recommended daily values or RDAs established by" the Institute of Medicine.

AHPA notes that FDA allows health claims and qualified health claims for nutrients such as soy, plant sterol/stanol esters, green tea and omega-3 fatty acids, although no RDAs or ULs are set for those substances.

"If OEHHA goes forward with this process, AHPA requests the office make efforts to identify all beneficial nutrients, which extends far beyond both those nutrients with RDAs and those with" health and qualified health claims, the group says.

CRN says beneficial nutrients are provided in both "traditional food" as well as supplements, but food items would not require a warning. The proposed changes would "unfairly" single out supplements for "disparate treatment" and "confuse consumers" about which products actually present potential exposures to listed chemicals, CRN says.

Both AHPA and CRN say they do not support the establishment of new regulatory language for the single instance. AHPA points out "the listing for retinol/retinyl esters already includes ... a quantitative limit below which no warnings are required."

Both groups ask OEHHA to dismiss the proposal.

AHPA encourages OEHHA to "include the level at which any listed chemical is identified as a carcinogen or reproductive toxin within any future listing, and note that if this mechanism is broadly adopted 'there would be no need for the possible regulatory language.'"

CRN says OEHHA should continue to rely on a case-by-case approach as it currently does with vitamin A.

Under Prop 65, products containing certain levels of known carcinogens or reproductive toxins are required to carry "clear and reasonable" warnings to alert consumers of the potential risk to their health.

In its pending proposal, OEHHA points out only two nutrients - chromium and vitamin A - are both a beneficial nutrient and a toxicant.

Chromium, as addressed by OEHHA's Food and Nutrition Board, is not the same chemical as "chromium (hexavalent compounds)," the chemical the agency lists as a carcinogen, the trade groups say.

For vitamin A, OEHHA lists "retinol/retinyl esters, when in daily dosages in excess of 10,000 IU, or 3,000 retinol equivalents," as a developmental toxin.

The agency also notes, "Retinol/retinyl esters are required and essential for maintenance of normal reproductive function. The recommended daily level during pregnancy is 8,000 IU."

- Rebekah Moan