supplement-warning-labelA customer wrote: I obtained a bottle of Quercetin by Nutricology because your site recommended this brand.  I was shocked to find a label affixed to the bottle proclaiming that it contained lead.  Do I need to be concerned about this and is there another brand that might be better?

Nutricology (and perhaps other therapeutic supplement companies) chose to put the California Prop 65 Lead Content warning on ALL of their products for which the highest possible dose exceeds the Proposition 65 maximum of .5 ppm (parts per million). As their Technical Support Manager writes:

“If we had chosen to not have a suggested dose on our labels or if we had suggested a lower dose which may not be efficacious for some, we would not have had to put the CA Prop 65 warning on any of our products. When you consider the fact that our products, even at the high end level still contain less than 1% of what is found in most foods in the US, where the danger lies, or if it exists becomes questionable.”

We Stock What Jini Uses

Each person should do their own research into health or manufacturing concerns. Jini conducts her research and then we stock the same products she uses for herself and her family.

Here is some of the information that Jini references on this subject and we encourage you to do your own research and then make your own decision according to your body wisdom.

More on The California Lead Warning Labels

According to Dr. Subhuti Dharmananda, Ph.D.:

The warning labels required by Proposition 65 do not present information about the safety or the risk of the products; the warning about lead does not specify the actual amount of lead that is present or whether any particular amount is harmful. The requirement for a warning label is triggered when the amount of a regulated substance in a product exceeds a certain regulatory level, which is very low in the case of lead.

According to the way Proposition 65 is worded and with the limited data about effects of exposure to lead, the labeling must be done if the total daily lead intake exceeds just 0.5 micrograms (µg).

Other Supplement retailers present data like this information below for comparison – to help you get a sense of the contamination risk:

Lead is an element that is found in almost all soil. The US Geographic Survey has estimated that the average lead content of completely uncontaminated soil in the US is about 16 parts per million (ppm). Over the last hundred years, lead-bearing fuels, paints, and other products have deposited man-made lead contaminants into the soil throughout the United States (and developed countries all over the world). Crops that grow in this soil will absorb this man-made lead. In the US, lead levels in soil are now considered “low” below 500 ppm, and are considered “high” above 1000. [Note1] The EPA requires that soils in children’s play areas must be under 400 ppm, and in other residential areas must be less than 1200 ppm. For comparison, EPA requires that children’s toys contain less than 100 ppm of lead.

The federal safety standard set by the FDA for lead in dietary supplements is no more than 10 ppm. International standards are often 5 ppm. But the Prop 65 “safe harbor” standard is 0.5 micrograms per day, meaning that a person may not be exposed to lead above this amount, for any product, without a Prop 65 warning. Setting aside the difficulties of translating this exposure level to a concentration level in a specific product, applying this standard to supplements means that lead content levels may need to be many times lower than federal levels, in order for a product to be sold without a Prop 65 warning. Above the “safe harbor” levels, a Prop 65 warning must be given to avoid lawsuits and potential liability. Similar “safe harbor” standards are set for over 800 other chemicals on the Prop 65 list.

How Much Lead Is In Food?

When grown in soil with a relatively “low” lead content (500 ppm), spinach and radishes can have lead levels that exceed 3 ppm, while beets and carrots can exceed 6 ppm. Also, herbs may contain over 90% water by weight, so lead levels in dried herbs can be up to 10 times higher than their fresh counterparts. In addition, it is difficult to get root crops (like radishes, beets or carrots) entirely free of the soil they are grown in, even with power washing. Good washing is critical, because at 500 ppm, even 1% of remaining soil, all by itself, would exceed the international lead standards for supplements. Under these circumstances, it is easy to see how it might be difficult to keep lead levels low in natural herbal products, and especially in root crops (which also include herbal root products like angelica, echinacea, licorice, or poria).

Even where Federal and International safety standards are clearly met, if there is any likelihood that lead (or any of the other 800+ compounds on California’s list) might exceed California’s “safe harbor” levels, then a Prop 65 warning is the only way to avoid expensive lawsuits.

By contrast, international regulations call for lead levels in herbs to remain below 10 ppm, with the strictest standards (outside of California’s Proposition 65) being 3 ppm in finished products; these amounts are readily detected by routine tests.  So, the Proposition 65 standard is set far below the lead levels allowed anywhere else (requiring special, expensive tests) and is not based on scientific analysis of actual risks, but on a regulatory system contained within the Proposition.

Why do some products have this warning, but many other products, for example, with Chinese herbs do not?

Proposition 65 labeling requirements are not uniformly utilized.  For example, if a company has fewer than 10 employees, it is exempt from the requirement to include warning labels; many Chinese herb manufacturers and distributors have fewer than 10 employees.

A method of avoiding warning labels is to undertake a legal challenge to the applicability of Proposition 65.  One company in California invested heavily in bringing experts from China to testify in court that the lead content of the Chinese herbs could be explained entirely from natural sources, which allows for another exemption from Proposition 65 labeling; the judge in the case determined that they had demonstrated the point, so they did not require labels on their products (but the judgment applied only to their products).

Some companies have not yet received a Proposition 65 action, so have not applied the labels.  Many supplement companies feel that the required labels are misleading rather than informative.

On The Flip Side…

However, naturopathic doctor Rick Liva writing in the Integrative Medicine journal has a different opinion. He likes to start by calculating the total daily heavy metal load in a supplement, by using this process. Then he says, I always err on the side of “the lower the better,” so I tend to use California’s Proposition 65 number of 0.5 μg of lead per daily serving. And, since this is not written in stone, I am OK if the number is slightly above that amount — it is still well below the other standards. If it’s significantly above, however, I tend to reject the product. Again, that is why the testing and evaluation are so important. Every company should do an upfront analysis.

As we said, you should do your own research and then make your own decision as to what you feel is safe for your body. The only guarantee we can give is that the products we sell in the Shoppe are the same ones that Jini uses for herself and her family.

Why Do Some Products Carry a Lead or Chemical Warning?
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