In 1986 California voters approved a law known as the Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65. Proposition 65 is a controversial California law that requires businesses to provide a warning label on products that contain any of over 800 chemicals, even when these chemicals are found in amounts that are exceedingly below the Food and Drug Administration (FDA) and World Health Organization (WHO) guidelines and internationally recognized standards for dietary supplements (ANSI 173). Such warnings are commonly seen in California on consumer products, restaurants, amusement parks, and many other locations. No other State has such a law.
WHY DO COMFORTABLY NUMB® PRODUCTS HAVE THE PROP 65 WARNING?
Comfortably Numb® products are safe! Since we use some essential oils on the Prop 65 list, we are required to advise our customers. These essential oils do not naturally contain harmful chemicals, but California is concerned about the air and soil in which they are grown. The amounts of essential oils used in our products are very small and well under what California has deemed critical for the warning. We work to ensure compliance with California’s Prop 65 Act and label the respective products accordingly.
WHAT TRACE CHEMICALS MIGHT BE PRESENT IN THE ESSENTIAL OILS WE USE (MINT, RAVENSARA, EUCALYPTUS, ORANGE AND LEMONGRASS.)?
Pulegone is a ketonic monoterpene that is a naturally present constituent in numerous plant species, especially mints (e.g., peppermint and spearmint) and particularly concentrated in the essential oils derived from these plants. Use of these plants and their essential oils as ingredients in foods, supplements, cosmetics and other consumer products may therefore result in the presence of small amounts of pulegone in these products.
It is important to acknowledge that the studies that resulted in OEHHA’s listing of pulegone as a carcinogen were tests of the toxicity of 96% pure pulegone on laboratory animals that were force-fed over virtually their entire lifetime doses that far exceed any human exposure related to common uses of mints and other plants and their essential oils. While appropriate as a hazard identification exercise, this research study does not constitute an appropriate risk assessment applicable to human exposure through normal dietary intake of this natural botanical constituent.
β-Myrcene is an acyclic, unsubstituted monoterpene found in numerous plant species such as hops, lemongrass, thyme, verbena, parsley, cannabis, and mangoes. It is used as an intermediate in the production of flavorings and fragrances. Use of these plants and their essential oils as ingredients in foods, supplements, beverages, cosmetics and other consumer products may therefore result in the presence of small amounts of β-myrcene in these products. β-Myrcene can also be produced through synthetic chemical pathways. The presence of synthetically produced β-myrcene in products sold in the State of California is not addressed by this guidance.
It is important to acknowledge that the studies that resulted in OEHHA’s listing of β-myrcene as a carcinogen were tests of the toxicity of over 90% pure β-myrcene on laboratory animals that were force- fed over virtually their entire lifetime doses that far exceed any human exposure related to common uses of β-myrcene containing plants and their essential oils. While appropriate as a hazard identification exercise, this research study does not constitute an appropriate risk assessment applicable to human exposure through normal dietary intake of this natural botanical constituent.
WHICH COMFORTABLY NUMB® PRODUCTS CONTAIN PULEGONE OR MYRCENE ON PROP 65?
Products that contain the following Essential Oils: Eucalyptus. The products with these specific oils include:
- The Original Comfortably Numb® Roll-on
- Comfortably Numb® PLUS Roll-on
- Comfortably Numb® Balm
- Comfortably Numb® PLUS Balm
HOW DOES PROP 65’S STANDARD COMPARE TO OTHERS ACROSS THE U.S.?
Prop 65 has among the most stringent standards in the United States. To provide some perspective, Prop 65 mandates a warning if there are more than 0.5 micrograms of lead consumed per serving, while the Federal Drug Administration’s (FDA) exposure level for infants and children is 60 micrograms per day—making California’s law 100 times stricter than federal standards. Virtually all botanical products contain lead and other heavy metals. For example, the typical amount of naturally occurring lead in 4-ounce servings of the following foods are well above the Prop 65 limit: avocado (4.5 micrograms – mcg), spinach (7.0 mcg), Brussel sprouts (7.9 mcg). As a result, it is extremely difficult to meet Prop 65’s Safe Harbor levels.
SHOULD I BE WORRIED ABOUT THE SAFETY OF COMFORTABLY NUMB® PRODUCTS?
Absolutely not! Comfortably Numb® products are safe. A Prop 65 warning does not mean that a product is unsafe. The standards for Prop 65 are extremely stringent—much lower than those established by the FDA. Comfortably Numb® never compromises on quality and has gone to great lengths to ensure our products are safe and we use the highest quality ingredients available. You can feel great about using Comfortably Numb® products with your family, animals and in your home. As always, do YOUR OWN research as to the ingredients in Comfortably Numb® products to make your own decision on whether to use our products.
Comfortably Numb® only uses herb supply sources that run a certificate of analysis to ensure they meet our quality specifications.. Please note that just because a different brand doesn’t have a Prop 65 warning label - doesn’t mean it is free of the regulated substance. In fact, many other essential oil and supplement companies also carry Prop 65 warning labels.
WHAT KINDS OF SUBSTANCES ARE GOVERNED BY PROP 65?
As a result of Prop 65’s stringent standards, the law lists chemicals that other government agencies consider perfectly safe. Ordinary foods and drinks, such as coffee, wine, chocolate, and potato chips, contain substances that fall under the Prop 65 warning requirement.
WHERE CAN I GET MORE INFORMATION ABOUT PROP 65?
To learn more about Prop 65 and to see a list of the more than 900 chemicals that require a warning label in California, you can go to http://oehha.ca.gov/proposition-65/about-proposition-65.