Natural Products Foundation
Tuesday, January 27, 2009
On Prop 65 Enforcement


By James Roza, CN

On December 23, 2008, fifty-six dietary supplement marketers were named as defendants in a lawsuit brought forth by the California Attorney General, alleging that multivitamins sold were contaminated with lead.

These cases came to the California attorney general's attention after, a company that tests consumer products, reported that a Vitamin Shoppe Multivitamin contained some amount of lead. This finding was related to the FDA in a letter from Henry Waxman, a Democratic Congressman from California. Waxman requested that the FDA investigate the matter and respond. After rigorous testing, the test results could not be authenticated by The Vitamin Shoppe or by the FDA.

In response to Congressman Waxman's request, the FDA also tested 324 multivitamin-mineral products that were labeled for women and children (the groups most vulnerable to lead exposure). Four of those 324 exceeded the FDA's recommended daily levels for lead (PTTI -- provisional total tolerable intake.)

Unfortunately, Waxman's home state of California decided to pursue the issue under their Proposition 65, The Safe Drinking Water and Toxic Enforcement Act of 1986. The FDA maximum PTTI levels are 6 μg for children up to the age of 6 years, 15 μg for children 7 years and older, 25 μg for pregnant women and 75 μg for adults. The maximum dose level allowed by California's Prop 65 is 0.5 μg/day, a fraction of the FDA's established norm. After the FDA published its results all of the companies whose Pb levels exceeded California's independently set standard became targets for the state, and many are now involved in the suit brought by the California Department of Justice. Over half of the 324 multivitamins that were tested for lead contamination were above California's Proposition 65 limit, while just over 1% of them actually failed the FDA's measure. Companies who are well within compliance with the FDA national standard are now being persecuted by the state of California.

This is a clear instance of state-level agencies attempting to superimpose their strictures over that of the federally established standards for operating. [Begin opinion] This is clearly a case of the tail wagging the dog and to the industryís chagrin has been going on for much too long. Although appeals to rescind Proposition 65 have been unsuccessful, other avenues need to examined to bring some common sense to a issue that seemingly continues to perpetuate it self. Clearly, the FDA and the State of California are at loggers heads about what constitutes a safety hazard and we need some rational discourse on both the Federal and State level to clearly assess what dangers lurk in the foods, supplements and beverages we ingest.

The intention of Proposition 65 to protect the health of the public has gone well beyond its bounds and has resulted in frivolous lawsuits that consume tax payerís time & money. What we need is some rational thinking and a critical review of what really poses a danger to the publicís health. This YouTube video by Penn and Teller is illustrative of what can happen when some critical thought isnít applied to issues that affect our safety.


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