The Truth About Herbal Medicine Warning Labels

Certain herbal medicine products may contain a warning label. This warning label is related to proposition 65 Safe Drinking Water and Toxic Enforcement Act of 1986. The proposition 65 warning labels warn that products with this label may contain various substances that cause cancer, birth defects or other reproductive harm. You many not only see these on herbal supplements, but also posted on other consumer products and at certain buildings. Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was intended by its authors to “protect California citizens and State’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposure to such chemicals.” With regards to herbal supplements, this is almost always referring to trace amounts of lead. Within the scientific community however, Proposition 65 standards are considered controversial, in part because they are not supported by factual data regarding harmful levels of lead.

You may think that lead at any level is bad, but actually it is impossible to avoid lead completely, because it occurs naturally in substantial quantities in the earth’s surface. Lead is present in all soils, rivers, lakes, and seawater. Lead is found in relatively low levels in common soil that is far from sites of contamination, and even healthy, natural, uncontaminated soil is never completely free of lead.

When measuring lead content, one of the commonly used designations for measurement is the proportion of lead in relation to all other components in any material. This is presented in terms of parts per million (ppm). So a level of 1 part per million (1 ppm) would mean that there is 1 microgram (1/1,000,000 of a gram) of lead in 1 gram of material (there are 28.34 grams to 1 ounce), or 1 milligram (1/1000 of a gram) in one kilogram of material (1 kilogram equal to 2.20 pounds). Below is a list of commonly measured lead levels to put these warning labels into perspective.

Lead Proportions in Various Substances                           parts per million (ppm)

Uncontaminated Soil                                                              0.5 – 10 ppm

Healthy Human Bones                                                           20 – 40 ppm

Japanese Herbal Medicine (allowed)                                       40 ppm

World Health Organization Herbal Medicine (allowed)        10 ppm

German & Australian Herbal Medicines (allowed)                  5 ppm

US Pharmaceuticals (allowed)                                                 3 ppm

Chinese Herbal Medicines                                                      1-3 ppm

California’s Proposition 65 requires a warning at only 1/2 ppm in food. In California, herbal medicine is regulated as a food substance. Did you happen to notice that US pharmaceuticals would require a warning label if they were not governed by separate laws? They actually contain more lead ppm than herbal medicine, and in the case of many vaccinations also contain mercury, aluminum, and other toxic substances that are detrimental to the body.

Lead Quantities in Various Substances                              micrograms (mcg)

Total Ingestion by Americans, per day                              up to 400 mcg

Typical American Diet, per day                                           15 – 25 mcg

Chocolate (2 oz bar)                                                            up to 43 mcg

Herbal Medicine Formula                                                     3 – 15 mcg

Chocolate actually contains more lead than herbal medicine, so why are there no warning labels on chocolate? The chocolate industry spent millions of dollars to prove that the lead in chocolate occurs naturally, and therefore cannot be considered a contaminant. Unfortunately when Proposition 65 was passed back in 1986, few of the then fledgling herbal companies in America had the money and resources to prove that the lead in their products also occurred naturally as a result of natural lead levels found in soil. This is the only reason you will find warning labels on herbal medicines and not on chocolate bars.

In addition, Proposition 65 is a law that is enforced by the public rather than the state’s attorney general. Under Proposition 65, ‘public enforcers’ are entitled to legal fees plus 25% of damages. The penalty for violating Proposition 65 is $2,500 per day per product on the shelf. Many of these products may have been on the shelf for years, and large settlements can be easy to extract for an experienced law firm. Enforcing Proposition 65 has been very profitable for a number or law firms and individuals. Because small companies are exempt, and larger companies have the resources to defend themselves, Proposition 65 bounty hunters tend to target medium-sized companies. Inconsistency in prosecution and settlements has created even more confusion and misinformation. While the attorney general must approve legal settlements, there are no legal standards or parameters, and no assurance of consistency. Settlements are negotiated entirely between the suing party and the party being sued, and each is decided on a case-by-case basis. Settlements made with private law firms have been widely varied in terms of penalties, label wording, and the amount of lead allowed. Details of settlements are usually kept private, so there is no way of knowing what each settlement required. What this has resulted in is a meaningless label that does nothing to truly inform the consumer.

Warning labels do not appear on all herbal supplements. Does that mean some products are more pure than others?

While some products are of higher quality than others, the Proposition 65 warning labels are not an indication of purity or quality. Inconsistencies within Proposition 65 labeling guidelines are to blame for this confusion. The contents of the bottle really have nothing to do with weather or not the product gets a warning label or not. Companies with fewer than 10 employees are exempt from Proposition 65. Technically speaking, products from these small companies can contain any amount of contaminants, and by law they don’t have to place a warning label on their products. This is not to say that products from small companies are inferior, because they are not. This is just a point to illustrate one of the many problems with this law in regards to herbal supplements.

More information on this topic can be found at the following:

“The Whole Truth About Lead in Herbs” by Joel Harvey, L.Ac.

Herbal Products and Proposition 65 FAQ’s

“Environmental Bounty Hunters, on Trail of Cash, Are in California Official’s Sights,” NY Times article on Prop 65

“Toxic Avengers” by Dorothy Pomerantz,

“Dr. Shen Returns to Whole Foods,” Press Release

“California’s Attorney General Acknowledges Prop 65 Abuse,” Washington Legal Foundation article on Prop 65

“Wayward Warnings,” Center for Consumer Freedom on Prop 65

Wikipedia on Prop 65