New Proposition 65 rules are in effect. Are you compliant?

Photo © iStockphoto.com/ Kuzma

Figure 1: Proposition 65 warning symbol to appear in front of warning text.

New regulations for Prop 65 warning labels went into effect on August 30, 2018. These changes have to do with how the warning label is displayed, including graphic design and wording, and when consumers are supposed to see it. These new requirements affect any products manufactured after August 30, 2018, while products manufactured before the cut-off are grandfathered in and able to use historic safe harbor warnings.

On-product labels for food, including dietary supplements, must contain a warning symbol or be set off in a black box. This warning symbol is a yellow triangle with an exclamation point at its center. Historic safe harbor warnings did not require this warning symbol (See Figure 1).

The content of the warning has also changed. Warnings found on signage or the internet, for example, must name at least one chemical in the product that is on the Prop 65 list and specify whether it can cause birth defects, reproductive harm, or cancer. Warnings must also list a website for Prop 65 information. The new warning looks like this:

WARNING: This product can expose you to chemicals including [name of at least one chemical], which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information visit www.P65Warnings.ca.gov.

Companies also have the option of using a shortened warning statement on products, although they must use the long-form warning on signage and on the Internet when people buy a product online. These changes were made because new safe harbor regulations require that consumers now be shown the warning before the point of sale. Previous regulation allowed for warnings after the point of sale, which companies would include on package inserts or invoices-both of which consumers only encounter after purchasing a product. The shorter warning is designed to help companies now find warning space on their labels at the point of sale. The shortened label looks like this:

WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov.

Additionally, e-tailers were previously not required to display warnings on their website if the product label displayed a warning. This has changed, however, and e-tailers must now display the long-form warning on their website so that consumers can view it before purchasing a product online. E-tailers are no longer able to simply list a small warning at the bottom of a webpage but rather must display the warning on each product page.

For brick-and-mortar retailers, the new regulations provide some protection [by putting the onus of compliance on manufacturers], says the American Herbal Products Association (AHPA; Silver Springs, MD). For example, the manufacturer, producer, packager, importer, supplier, or distributor must notify retailers when warning is required and must have confirmation of receipt of this notice from the retailer they notified. Retailers are, however, held responsible for house brands or not posting warnings despite knowledge that a product requires warning.

AHPA has updated its Prop 65 Guidance for herbal products and cannabis products to reflect these changes. Being compliant with Prop 65 and using safe harbor warnings is an important way to protect one’s business from lawsuits and class actions. Certain processed botanicals are currently on the Prop 65 list, most recently, Aloe vera (non-decolorized whole leaf extract), and goldenseal root powder, both of which were added on December 4, 2015. Another concern for herbal supplement manufacturers is heavy metals, namely arsenic, cadmium, lead, and mercury, as well as naturally occurring botanical constituents pulegon and beta-myrcene.

Heavy metals can be naturally found in soils throughout the world, though human contamination is also a factor that raises heavy metal content in botanicals. There are safe harbor levels for heavy metals, below which do not require a warning but if exceeded do. This requires testing the heavy metal content of the product and as AHPA points out in its guidance, certain factors need to be considered when determining if a warning is required. For example, the guidance states, “A manufacturer must make a calculation that takes into account the amount of the product consumed per day in ordinary use."

AHPA explains: “For example, if an herbal tablet of 500 mg is found to contain 0.4 ppm of lead, and the usual consumption rate (often, but not necessarily, the same as the labeled serving size) is one tablet twice daily, the daily consumption of lead can be calculated to be 0.4 μg per day (0.4 ppm [concentration of lead in tablet] × 0.5 gram [weight of tablet] × 2 tablets/day = 0.4 μg/day) and will therefore be below the limit which would require a warning as a reproductive toxin. If, however, the product is usually consumed at the rate of three tablets per day, the daily consumption of lead will increase to 0.6 μg (0.4 ppm × 0.5 gram × 3 tablets/day = 0.6 μg/day) and a warning would therefore be required under the law.”

It’s important to note as well that there are two separate safe harbor levels that quality a product to be at risk as carcinogenic or to cause reproductive harm/birth defects. In the above example, 0.6 μg/day exceeds the safe harbor levels for reproductive harm, but not as a carcinogen, requiring only the one warning.

Taking advantage of resources like AHPA's Prop 65 Guidance is a great start to being compliant, though proper legal counsel is key.