From the desk of TeriAnn Trevenen, founder of AnnieMak.
Thank you for your inquiry about the new California Proposition 65 sticker on a couple of our products.
If you're a California resident or you've purchased skincare or supplement products from California, by now you've probably seen the Prop 65 warning label that's placed on thousands of products.
These labels are infamous for their severe warnings and it’s only normal to be concerned when you see such warnings on something you are about to use or consume. However, many products forced to use these labels already meet or exceed current regulations set by the FDA, EPA, and World Health Organization.
What is Prop 65?
In 1986, environmental and public health activists persuaded California voters to approve the Safe Drinking Water and Toxic Enforcement Act — more commonly known as Proposition 65 or Prop 65.
Although the intentions behind Prop 65 were to improve public health, very little improvement has actually resulted. It’s questionable whether or not the burden placed on California businesses and businesses that sell products in California has been worth it.
Prop 65 requires:
The State of California to identify chemicals that could potentially cause cancer, birth defects, or reproductive harm. Each new chemical discovered is added to a list managed by the state. The list total is over 900 chemicals and counting.
Businesses are required to warn consumers of any possible exposure to one of the chemicals on the list, despite the actual amount of ingredient or realistic risk of exposure. To accomplish this, businesses are required to post in-store signs and/or warning labels on specific products among other requirements.
What kind of chemicals are on the Prop 65 list?
There are currently 900 chemicals listed on the Prop 65 list, and it is growing. Most of these chemicals are items that we use in our everyday lives and are naturally created. Please refer to this link for a full listing of the current chemicals associated with Prop 65: https://oehha.ca.gov/proposition-65/chemicals
How does a chemical qualify to be on this Prop 65 list?
Prop 65 sets a “Safe Harbor” exposure level for many of the listed chemicals. Amounts less than the established Safe Harbor level do not require a warning label. Yet, these Safe Harbor levels are frequently around 1,000 times lower than levels set by the FDA, EPA and WHO (World Health Organization).
In many instances, the exposure levels determined by Prop 65 are lower than what occurs naturally in fruits, vegetables, grains, and even drinking water.
For example, take a look at the naturally occurring lead counts in the foods below.
24x higher lead-count than the Prop 65 limit:
- Italian salad dressing — 12.2 mcg
- Roasted mixed nuts (no peanuts) — 10.2 mcg
- Fried beef liver — 9.0 mcg
16x higher lead-count than the Prop 65 limit:
- Fresh, boiled brussel sprouts — 7.9 mcg
- Fresh, baked sweet potato — 7.2 mcg
- Boiled spinach — 7.0 mcg
- Dry table wine — 6.8 mcg
16x higher lead-count than the Prop 65 limit:
- Raw avocado — 4.5 mcg
- Honey — 4.5 mcg
- Raw watermelon — 4.5 mcg
- Raisin bran cereal — 4.1 mcg
- Dried raisins — 3.5 mcg
- Cottage cheese (4% milk fat) — 3.4 mcg
- Raw cucumber — 3.4 mcg
- Raw peach — 3.4 mcg
- Granola cereal — 3.0 mcg
- Raw red apple — 2.6 mcg
Prop 65 provides a warning-label exceptions for naturally grown foods.
Some of the ingredients in AnnieMak’s products are by-products of accepted fruits and vegetables, which naturally absorb minerals in their growth process to give them their healthy characteristics. However, Prop 65 lacks clear guidelines on providing warning-label exceptions for these nutritional supplements that are derived from these naturally evolved foods. AnnieMak believes that our products should be exempt from providing the Prop 65 warning labels as the correlation between our ingredients and the items listed by Prop 65 should be waived as part of the “naturally occurring allowance”.
California’s Prop 65 vs National Standards
One of the interesting aspects of Prop 65 is how different it is from all of the other national standards set by organizations such as the FDA and EPA. Prop 65 is significantly more strict.
Continuing with the example of lead, which is naturally occurring throughout the environment and notably in our soil, we see a stark contrast between Prop 65 and the national standards.
According to the EPA, natural levels of lead in soil can range from 50 parts per million (ppm) to 400 ppm. When you account for the amount of lead in the soil from man-made pollution, some areas contain up to 10,000 ppm. Granted, these are contaminated areas usually near factories.
Even when grown in soil with lower lead content (500 ppm), vegetables such as spinach and radishes can contain enough lead to exceed 3 ppm. Other vegetables, such as beets and carrots, can have over 6 ppm.
This is why it’s virtually impossible to manufacture natural products, like ours, that don’t contain trace amounts of lead, especially for herbal roots. However, keeping those levels far below the national standards is definitely possible and we’ve certainly done so for all of our products.
The federal safety standard set by the FDA for lead in dietary supplements is a maximum 10 ppm. International standards vary, but typically are set around 5 ppm.
The Prop 65 Safe Harbor maximum allowable dose level for lead is 0.5 micrograms per day, but the FDA daily limits are set at 75 micrograms for adults and 6 micrograms for children. The European Food Safety Authority estimates the average adult consumes around 50 micrograms per day, which is 100 times the Prop 65 limit.
Any product in California that might cause someone to be exposed to more than 0.5 micrograms per day requires the Prop 65 warning label. However, most food and supplement products with the Prop 65 warning label are still well under the national limit and only contribute a fraction of the average person’s daily exposure to lead.
Why don't all supplement products have a warning label?
There are several likely scenarios where a manufacturer might not use a Prop 65 warning label, such as:
- They believe their product is below the Safe Harbor limits
- The supplier is unaware of the legal risks of not using the Prop 65 warning label
- They plan to start using the label, but haven’t yet
- In all reality, some companies would rather risk the legal fees than scare people with a nasty Prop 65 warning label.
Why is there a warning label on some our products?
We, like all other companies that sell products in California, are required to provide consumers with an indicator if a single element is present that is listed on California’s list of chemicals associated with the Prop 65 mandate.
As we shared earlier, raw avacados, raw apples, raw honey and many other fruits, vegetables, and herbs naturally have higher levels than what Prop 65 deems acceptable.
Since our products are made from whole food, fermented and sprouted organic ingredients, some of our products naturally have higher amounts than what prop 65 allows and so we have to add a label.
AnnieMak believes that our products should be exempt from providing the Prop 65 warning labels as the correlation between our ingredients and the items listed by Prop 65 should be waived as part of the “naturally occurring allowance”.
What does this mean for AnnieMak products?
While we are mandated to provide this Prop 65 warning label on a few of our products, AnnieMak ensures that our ingredients are natural, pure, non-toxic and in most cases organic. In fact, some of the ingredients in our nutritional supplements are by-products of accepted fruits and vegetables, which naturally absorb minerals in their growth process to give them their healthy characteristics. Prop 65 provides a warning-label exception for these naturally grown foods.
However, Prop 65 lacks clear guidelines on providing warning-label exceptions for these nutritional supplements that are derived from these naturally evolved foods. AnnieMak believes that our products should be exempt from providing the Prop 65 warning labels as the correlation between our ingredients and the items listed by Prop 65 should be waived as part of the “naturally occurring allowance”.
Nevertheless, as partners in your decision-making for good health, AnnieMak is committed to ensuring that you are always fully informed so that you can make the best decisions for you and your family’s health.
Our entire team is dedicated to supporting you in providing good health solutions. Please do not hesitate to reach out to us if you have any questions or concerns.
We are here for you!
Thank you for your continued patronage and I’m excited to be able to provide you with some of the best supplements available for you and your family.