CPSIA Update: Safe Vitamins Versus Safe Books and Baubles

By August 14, 2009Regulations

Today marks the effective date for the Consumer Product Safety Improvement Act’s lower standard for lead content in children’s products, dropping from 600 parts per million (ppm) of lead to 300 ppm as of August 14. (CPSC release, earlier post, more from Overlawyered. Good AP story.)

However, as a number of Consumer Product Safety Commission votes on petitions for exemptions have shown (books, and beads and crystals) the ban really affects products that could conceivably permit “any” absorption of lead. That makes the effective standard 0 ppm. As in zero.

So it’s OK for children’s vitamins to contain minute amounts of lead, but not, oh, a little girl’s tap shoes with sequins must be tested and certified as having no lead at all?

That’s right. Children’s vitamins may have tiny, infitesimal amounts of lead and still be safe and legal. The Food and Drug Administration in 2008 released a report, “Survey Data on Lead in Women’s and Children’s Vitamins.”

Estimates of Pb exposures from consumption of products were derived by multiplying the maximum recommended daily serving provided by the label instructions by the Pb mass fractions (i.e., concentrations) determined in this study. The overall median value for Pb exposure was 0.576 µg/day. Five samples would have provided exposures that exceeded 4 µg/day, the highest being 8.97 µg/day. The highest exposure estimate for children’s vitamins was 2.88 µg/day. Estimates of exposures were assessed with respect to safe/tolerable exposure levels that have been developed for particular age and sex groups. These safe/tolerable exposure levels are referred to as the provisional total tolerable intake levels (PTTI)

To make things a little clearer…

Here’s the key excerpt from the next paragraph: “Estimates of Pb exposures for all products were below the PTTI levels for the at-risk population groups of children, pregnant and lactating women and adult women.”

Pb refers to lead, and PTTI stands for provisional total tolerable intake levels, i.e., safe and acceptable levels. And the products were children’s and women’s multivitamins. In other words:

Estimates of lead exposures for all products were below the safe and acceptable levels for the at-risk population groups of children, pregnant and lactating women and adult women.

So the FDA regards it as acceptable for vitamins to contain extremely small amounts of lead, vitamins that children actually eat.

But products that children may occasionally touch with their hands must not have any lead in them — ANY — thanks to the Consumer Product Safety Improvement Act.

In case anyone misses the point, it’s not that vitamins are unsafe. On the contrary: The FDA uses science, risk assessment and a sense of reality to determine what are safe levels of lead exposure for the most vulnerable people, children including.

The CPSIA does not.

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