Nutritional science for mind health products
DSM Nutritional Products
Proposition 65 was enacted in 1986 in California to protect the state's citizens from exposure to certain harmful chemicals.
The Office of Environmental Health Hazard Assessment (OEHHA), which is the main agency for implementation of Proposition 65, last month proposed a 'conceptual' regulation under Proposition 65's implementing regulations to exempt listed chemicals that are also beneficial nutrients in food.
Exemptions
"Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops. Excessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects," said OEHHA.
"OEHHA is seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods."
Under the draft regulatory language, the agency proposes that if a listed chemical is shown to be beneficial to human health and does not exceed the Recommended Daily Allowance (RDA), then consumption of this in a food would not be considered 'exposure'.
The agency said that a chemical is considered beneficial to human health if a daily value or allowance has been established for it by the Institute of Medicine (IOM).
Industry opposition
However, in response to a call for comment on this draft language, OEHHA received strong opposition from food and supplement trade groups, including the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the Grocery Manufacturers Association (GMA).
The main causes for objection were that the proposal is unnecessary and that the reliance on RDAs and Upper Level (UL) intakes is faulty.
Irrelevant regulations
The industry groups said there is no current need for such regulation as there are currently no chemicals listed in Proposition 65 that would actually be exempt under the proposal.
OEHHA had identified two listed chemicals - chromium and vitamin A - as 'beneficial nutrients'.
However, commentators at the workshop held last month to discuss the proposal pointed out that chromium hexavalent - the only form of chromium on the list - is not, in fact, a nutrient. In addition, vitamin A is listed with a qualification that would place it beyond the scope of the proposal.
Measuring nutrients
Additionally, the proposal "misunderstands the purposes and limitations of" RDAs and ULs, said CRN. Neither RDA nor Daily Value is an appropriate measure of optimal nutrition, it said.
"While the RDA (determined by the Institute of Medicine's Food & Nutrition Board), and even the Daily Value (set by FDA) are intended as markers for the beneficial effects of nutrients, neither value is based on the avoidance of adverse effects of excessive intakes and thus, neither is valid as a threshold for avoiding carcinogenic or developmental or reproductive risks," said CRN.
The group highlighted that RDA is the recommended amount to avoid nutrient related deficiencies. Many nutrients, such as Vitamin C, show beneficial health effect at levels far above their RDA, and some health benefits may not even be present at the RDA level but are apparent only at higher levels.
In addition, not all nutrients have an RDA or DV established, and any Proposition 65 warning that might be required in the future could not be based on these values, said CRN.
The trade groups requested that OEHHA withdraw the proposed regulatory language.
However, if the agency were to decide to go ahead with the process, AHPA said that "significant changes" would be necessary. These would include identifying all 'beneficial nutrients' and not just those with RDAs.
To access all information and comments on the proposal, click here .