What is Prop 65?

What is Prop 65?

Proposition 65 (Prop 65) is a California law formally known as the Safe Drinking Water and Toxic Enforcement Act, which was enacted in 1986.¹ It is a right-to-know law requiring the public to be informed when a substance on the Prop 65 chemical list is present above a very low threshold. The law is unique to California and is not a national standard related to health or safety. No other state has such a labeling regulation. In California, even if a product is safe, Prop 65 requires a consumer warning if it contains 1 of approximately 900 listed substances.²

Do all products need a Prop 65 warning?

No, not all products need a Prop 65 warning. The law requires that a warning is provided if a product meets two criteria: 1) it is sold in California and 2) it contains 1 or more of the nearly 900 substances that are included on the Prop 65 list.³ The law specifically mandates that the level of a listed substance requiring a warning be significantly lower than the level at which any harm has been documented. In many cases, the substances in question occur at levels much too low to cause any measurable health effect, and there is often no known link between exposure to the substances at these low levels and any actual risk of cancer or reproductive harm.⁴

For example, the warning threshold for potential reproductive toxins is 1,000 times lower than the level found to cause no reproductive harm. In essence, if animal studies suggest that a human could consume up to 1,000 grams of a compound and still not experience any reproductive effect, Prop 65 requires a warning on a supplement containing just 1 gram or more of the compound.

Why is lead found in foods, vitamins, and minerals?

Widespread in nature and in soil, lead is found in low levels in many foods and dietary supplements. Some Prop 65–listed chemicals are naturally present in plants and animals that are used as food. A perfect is example is a compound known as safrole that is found in basil and black pepper.⁵ Other Prop 65 chemicals are formed when food is cooked or processed, such as acrylamide in coffee or ethanol in alcoholic beverages. Fortified foods, such as those with added vitamin A, have a Prop 65 substance intentionally added.⁶ In addition, the Canadian government has indicated that the most significant dietary sources of lead come from beverages (including beer, wine, tea, and soda), cereal-based foods, and vegetables.⁷

What kinds of substances are on the Prop 65 list?

The Prop 65 list includes a wide range of substances, including both man-made chemicals and those that occur in nature. The substance does not have to be intentionally added to the product to trigger the Prop 65 warning. ⁸

How is the limit for lead determined?

The warning level for lead is set by the California Office of Environmental Health and Hazard Assessment (OEHHA). The group identifies the level of exposure that has been shown to not pose any harm to humans or laboratory animals and then adds a large margin of safety.⁹More specifically, the “no observable effect level” is divided by 1,000 as the margin of safety. In other words, this margin of safety requires companies to use a warning if there may be an exposure that exceeds 1/1,000 of the no observable effect level (NOEL). Based on its NOEL, the warning level for lead is set at 0.5 micrograms. For context, a microgram is one millionth of a gram.

How does the Prop 65 lead level of 0.5 micrograms compare to levels of lead in food?

Prop 65 requires the warning for products sold in California that contain over 0.5 micrograms (mcg) of lead per maximum daily usage.  The amount of lead in foods ranges from undetectable to over 0.5 mcg per serving. Some examples of foods with over 0.5 mcg lead per serving are shown here:

  
Are products sold at Village Green Apothecary safe?

Yes, products sold at Village Green Apothecary are safe when taken according to the product directions. Consulting your doctor or health care provider is always recommended when selecting a dietary supplement. Selecting and partnering with high-quality manufacturing partners is fundamental to ensuring the safety of our products.

The FDA has established a current interim reference level for lead as 12.5 mcg per day for adults. This level allows for differences across adult populations and is nearly ten times less than the actual amount of intake from food. For more information, see Lead in Food, Foodwares, and Dietary Supplements on the FDA’s website. The total amount of lead in our vitamins hovers between less than 0.5 micrograms and 1 microgram. For comparison, a half cup of cooked spinach has about 0.9 mcg of lead.

The United States Pharmacopeia (USP) is a source for testing standards that are recognized by the FDA for pharmaceutical drugs. The USP has also created heavy metal standards for dietary supplements. Currently, the USP’s permitted exposure to lead in dietary supplements is 10 mcg/day. By comparison, Prop 65 mandates that companies place a warning for lead on their product if it exceeds 0.5 mcg/day. As mentioned above, a microgram is one millionth of a gram. Click here to learn more about what the USP does.

How is Proposition 65 enforced?

Prop 65 is enforced through lawsuits brought by the state attorney general, district or city attorneys, or private plaintiffs. A plaintiff does not need to show that anyone has been hurt in order to bring a lawsuit.

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¹https://oehha.ca.gov/proposition-65/proposition-65-faqs
²https://oehha.ca.gov/proposition-65/proposition-65-list
³https://oehha.ca.gov/proposition-65/proposition-65-list
⁴https://oehha.ca.gov/proposition-65/proposition-65-faqs
⁵vwww.ahpa.org/consumers/CaliforniaProposition65FAQ.aspx
⁶www.ahpa.org/consumers/CaliforniaProposition65FAQ.aspx
⁷California Health and Safety Code, Chapter 6.6, section 25249.10(c)
⁸OEHHA “Chemicals Known to the State to Cause Cancer or Reproductive Toxicity” http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html
⁹California Health and Safety Code, Chapter 6.6, section 25249.10(c)
¹⁰https://www.fda.gov/downloads/Food/FoodScienceResearch/TotalDietStudy/UCM184301.pdf