Have you seen a Proposition 65 warning on a product website page and wondered if the product is safe to use? Or, have you visited your local (California) Starbucks and seen a warning poster and wondered what this means? Below find answers to some frequently asked questions related to this confusing California statute.
What is California Proposition 65?
CA Prop 65 is a law that requires a disclosure to California consumers of exposure to certain chemicals listed by the State of California. Known as the Safe Drinking Water and Toxic Enforcement Act, this environmental safety regulation was passed in 1986 to protect the state’s water sources. This law is more commonly referred to as Proposition 65 or Prop 65.
What Types of Chemicals are on the Prop 65 List?
The list, which is updated each year, includes a wide range of synthetic chemicals such as such as pesticides, dyes, and solvents plus naturally-occurring chemicals such as arsenic, cadmium, lead and mercury. Listed chemicals may also be used in manufacturing and construction, or they may be by-products of chemical processes.
How do Chemicals Get Added to the Prop 65 List?
All of the 800+ chemicals listed under CA Prop 65 have been shown to potentially cause cancer or birth defects. The threshold level for each chemical is often based on tests which use very high doses of chemicals performed in experiments on laboratory animals.
Which California Businesses Require Warnings?
Prop 65 warnings are seen throughout California in a wide range of settings – in restaurants, grocery stores, hotels, schools, hospitals, and gas stations. Even Disney Resorts displays Prop 65 warning signs throughout the company’s parks. The warning is also found on a wide variety of consumer products including personal care, cosmeceuticals and nutritional supplements.
Are Prop 65 Products Banned?
No. Proposition 65 does not ban products that expose individuals to these chemicals, but it does require businesses to inform consumers about potential exposure to harmful toxins. The warning, however, does not necessarily imply that a product violates safety standards or requirements.
What Prop 65 Chemicals are Found in Foods?
Acrylamide, alcoholic beverages, bisphenol A (BPA), DEHP, mercury and lead are the most common Prop 65 chemicals found in food products. Acrylamide forms when food is cooked or processed at high temperatures. The chemical is found in baked and fried goods like French fries, potato chips, baked snack foods, roasted nuts and coffee beans. Companies like Starbucks and Coffee Bean & Tea Leaf must now prominently display a Prop 65 warning in their California stores indicating that their products expose consumers to a chemical that may cause cancer. Read here for a story on the controversy that recently appeared in the New York Times.
What Prop 65 Chemicals are Found in Cosmetics & Personal Care Products?
Cocamide DEA is a foaming compound that is widely used as an emulsifying agent in personal care and bath products like shampoos and hand soaps, and in cosmetics. Other ingredients that are on the Prop 65 list include phthalates (used in plastics) and formaldehyde which is found in personal care products.
What Prop 65 Chemicals are Found in Supplements?
The Prop 65 chemicals that occur naturally in nutritional supplements include four heavy metals: arsenic (found in rice), mercury (found in fish oil supplements), cadmium (found in chocolate protein powders) and lead (found in botanical, calcium containing supplements). Many plant-based products may have higher contamination levels because plants are especially prone to absorbing heavy metals like lead from soil. And once lead gets into or on a plant, it cannot be completely removed by washing or other food processing steps.
What is the Source of Naturally Occurring Heavy Metals?
Certain heavy metals, such as lead, are widely distributed through the environment in air, soil, water, and rocks. As a result, these types of chemicals are often found in commonly eaten foods and throughout the food supply even though these chemicals are not intentionally added to foods or to nutritional supplements. The heavy metal arsenic, which leaches from bedrock, is prevalent in New England well water.
What Does Safe Harbor Mean?
Prop 65 establishes a safe level for each chemical. If exposure is below this level, then a warning is not required. These safe harbor levels must fall below the Maximum Allowable Dose Levels (MADL) for chemicals listed as causing birth defects or other reproductive harm.
Are Organic Products Lower in Heavy Metals?
No. In fact, organic products may have higher levels of heavy metals than non-organic products. In a recent study from the Clean Label Project, researchers found that certified organic plant-based protein powders had twice the amount of lead and other contaminants compared with animal-based protein powders. Because heavy metals are routinely found in soil and plants, it is not surprising that plant proteins (e.g., soy, pea) contain trace amounts of heavy metals.
What is a Prop 65 Warning Statement?
The law is very specific in how the warning statement is displayed on product packaging and websites. Here is an example of a warning for lead:
“CA Prop 65 WARNING: Consuming this product can expose you to chemicals including lead, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/food.”
How do CA Prop 65 Standards Compare with Federal Standards?
Prop 65 standards are far more stringent than federal standards. For example, the CA Prop 65 level for lead is 0.5 micrograms per day. At the federal level, the U.S. Food & Drug Administration (FDA) has set the safe and tolerable daily intake for lead in adults at 75 micrograms per day, or 150 times the amount requiring a warning in California. By comparison, the amount of lead found in a wide variety of commonly consumed foods is much higher. For example, a 4 oz. serving of shrimp, sweet potato and cucumber contains 23.8, 7.2 and 3.4 micrograms of lead, respectively.
What are Prop 65 “No Significant Risk Levels”?
For chemicals that are listed as causing cancer, the no significant risk level is defined as a 1 in 100,000 chance of developing cancer over a 70-year lifetime. For reproductive toxicants, the level required for warnings is 1,000 times lower than the lowest level at which animal studies reported no reproductive health effect.
Are Products with a CA Prop 65 Safe?
Most likely, yes, these products are safe to consume. A Prop 65 warning does not mean that the product will actually cause cancer or other reproductive harm when the product is used in its typical way (remember the coffee warning). And the warning doesn’t automatically indicate that the product is unsafe.
Are Products Without a Prop 65 Warning Safer?
Not necessarily. Just because a dietary supplement or cosmetic product does not include a CA Prop 65 warning does not necessarily mean that the product has a lower chemical content. Many companies are unaware that the California warning needs to be on packaging especially if they are an out-of-state company. Ironically, it is very possible that products without a CA Prop 65 warning could have a much higher level of a Prop 65 chemical than a product with a warning. Because of inconsistent Prop 65 enforcement, this sometimes explains why you will see certain products in the market with warnings, and virtually identical products without warnings.
Does Dosing Affect Exposure to Chemicals?
Yes. A product that does not include a Prop 65 warning is not necessarily chemical-free. In this case, the amount of a chemical per serving is likely below the Maximum Allowable Dose Level. For example, a calcium-containing tablet that provides 650 mg of calcium (from calcium carbonate) plus 0.30 mcg of naturally occurring lead per serving would not require a Prop 65 warning. However, if your doctor advises you to obtain 1,300 mg of calcium daily and you opt to take two tablets of this supplement, your lead intake would be 0.60 mcg/day – or slightly above the CA Prop limit of 0.50 mcg/day.
While Prop 65 was borne out of good intentions, it’s implementation and inconsistent enforcement has resulted in less clarity and more confusion for consumers.
Based on this information, what can you do?
When selecting the foods you’ll consume or the cosmeceuticals you’ll apply on your skin or the dietary supplements you’ll ingest, it’s important to balance the benefits and risks of using the product. Coffee is a good example where the demonstrated health benefits far outweigh the infinitesimally small risk of developing cancer as a result of consuming this beverage over time.
In the case of dietary supplements, certain types of products especially those that contain, calcium, cocoa powder or herbs will naturally have higher levels of heavy metals, especially lead, in the finished product. Finding an alternative supplement that offers that same benefits may not be possible. For example, hypericin and hyperforin, active constituents associated with antidepressant benefits, are only found in supplements that contain St. John’s Wort.
Finally, some risks are only relevant to women who are pregnant or nursing. Women who are pregnant are advised against eating fish species like swordfish and albacore tuna which can contain high mercury levels. As a result, many pregnant women have stopped eating fish altogether due to this warning. However, the FDA now recommends that pregnant or breast-feeding women consume at least two servings of low-mercury seafood a week so that they don’t miss out on the developmental and health benefits that fish can provide. For additional advice visit the American Pregnancy Association website.
David H. Rahm, M.D. is the founder and medical director of The Wellness Center, a medical clinic located in Long Beach, CA. Dr. Rahm is also president and medical director of VitaMedica. Dr. Rahm is one of a select group of conventional medical doctors who have education and expertise in functional medicine and nutritional science. Over the past 20 years, Dr. Rahm has published articles in the plastic surgery literature and educated physicians about the importance of good peri-operative nutrition.