NEWS FLASH — Is Prop 65 being used to shake down supplement companies in CA?

At the web site of CA’s Office of Environmental Health Hazard Assessment (OEHHA), Prop 65 is described as the approval by CA voters in 1986 of an initiative to address their growing concerns about exposure to toxic chemicals. That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65. Proposition 65 requires CA to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 775 chemicals since it was first published in 1987. Additionally, Prop 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment. By providing this information, the goal of Prop 65 is to enable Californians to make informed decisions about protecting themselves from exposure to these chemicals.
The list of chemicals on the Prop 65 list includes a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.
In the wake of growing realization and concern that Americans were consuming potentially dangerous amounts of toxins that include mercury in their fish, CA Attorney Bill Lockyer filed a complaint in 2003 alleging that several CA Grocers Assn. members violated Prop 65 by failing to provide clear warnings to their customers regarding purchasing tuna, swordfish, and shark. Click here to read the entire story. The California Medical Association (CMA) passed a resolution encouraging physicians to educate their patients on the dangers of mercury in food, particularly fish, and to advise pregnant women and children to limit consumption of fish with significant concentrations. They cited that mercury is toxic to the nervous system and particularly to a developing fetus. According to Rob Margolin, chairman of the CMA’s San Francisco delegation, “We consider fish to be healthy. But fish that is high in mercury, we’re coming to learn, can be quite dangerous.”
One of the contentious issues at the 2003 annual meeting of the CMA was the question of labeling fresh, packaged and canned fish. The CMA push was to study the issue more fully, better measure mercury in fish and educate the public. CMA referred their resolution to the American Medical Association. The irony of all this is that many physicians who identify and seek to treat heavy metal intoxication in their patients have been the target of state medical boards for practices outside the standard care of care for the respective state. Richard Kunin, MD in San Francisco has been targeted for this very practice which dates back to the 1960s of screening for heavy metals when appropriate. The same has been true of many integrative physicians in many states.
In 2003, scientists in the Centers for Disease Control and Prevention published a paper on mercury in fish in the Journal of the American Medical Association, based on a CDC study released in February 2003 on human exposure to environmental chemicals. In examining the U.S. data, they found that mercury levels among women who ate three or more servings of fish in the prior 30 days were almost four times higher than among women who ate no fish. Levels were almost twice as high in children who ate fish compared to children who didn’t eat fish, the study found. Mercury is now linked to heart disease in an increasing number of studies as well as clinical practice.
Lead is another heavy metal that has recently been the study of scrutiny in the mainstream medical media. In 2003, 2006, and 2008, articles appeared at Medscape, linking lead exposure to elevated blood pressure.
Now the CA attorney general has listed a 60-day notice to 73 supplement firms on the basis of a complaint lodged by Vicky Hamilton of lead in supplements manufactured by these firms. The language of Prop 65 calls for a reward to be paid under Section 25191.7 before the fines are accordingly distributed. Lead levels permissible under Prop 65 are lower than levels naturally occurring in some foods and lower than the acceptable limit set by the FDA. While one could interpret the recent legal actions as an abuse there is also the troubling issue that natural ingredients in supplements contain lead at levels higher than that allowed by Prop 65. Supplement firms are targeted under Prop 65 regulations yet their products are not contaminated. For example, a single serving of spinach contains 8.5 mcg. of lead. The Prop 65 allowable limit for lead for pregnant and nursing women is 0.5 mcg. A supplement firm, Rainbow Light, has analyzed the dilemma of supplement firms who take great care to insure ingredient quality yet these ingredients naturally contain lead in an amount that exceeds that set by Prop 65. Click here to read more. Consider the supplement companies’ dilemma now that they face legal action and fines under Prop 65.
Swanson Health Products according to Kari Graber, the Quality Control Compliance Manager, has filed a petition with the FDA; click here to read more; to address the language of the Prop 65 law and how it is being enforced. In the world of class action lawsuits often gone wild, it is reminiscent of one of the many reasons non-partisans groups like Common Good, , have been launched to restore common sense to America legal reform. By conducting polls, hosting forums, and engaging with leaders in health care, education, law, business, and public policy from across the country, Common Good is developing practical solutions to restore reliability to our legal system and minimize the impact of legal fear in American life. In this case, the legal fear has been struck in the offices of 73 supplement firms.The dietary supplement industry in the wake of FDA inaction to set standards for supplement quality control stepped up to the plate to create GMP (from the Natural Products Association) and USP verified to verify the identity, strength, purity, and quality of dietary supplement finished products, dietary supplement ingredients, and pharmaceutical ingredients. Many dietary supplement firms produce products with exemplary quality control. Maintaining standards to protect all the consumers who regularly use dietary supplements to optimize their health is favored by all. Shaking down supplement firms (complaints about 73 firms from one consumer) is yet another example of how the regulatory structure in this country is manipulated to the detriment of those in integrative health.
Freedom to choose and use supplements wisely is key to good health. Painting supplements with a black brush as somehow contaminated because of an arbitrary level set by CA Prop 65 does not further optimizing health. Your support of AAHF is key to maintain health freedom defined to be the right of the practitioner to practice and the consumer to choose.