Manufacturer Policies

Minimum Internet Advertising Price Policies

Below are the manufacturers MAP or IMAP policies related to how the respective manufacturer’s products may be advertised and sold.

Aubrey Organics, policy as of 2021

Ayush Herbs, policy as of 2022

BioAllers, policy as of 2021

Douglas Laboratories Corporation, policy

Protocols For Life Balance, policy as of 2011

Pure Encapsulations Inc., policy as of 2021

Thorne, policy as of 2016

Zane, policy as of 2021

Manufacturers Proposition 65 (Prop 65) Policies and Warnings

Prop 65 FAQs

What is Proposition 65?

In 1986 – almost 30 years ago – due to concern over exposure to toxic chemicals, California voters passed a citizen initiative, the Safe Drinking Water and Toxic Enforcement Act, or, as it’s now universally known, Proposition 65. This citizen-based initiative, which is now the law in California, requires the State of California to publish two lists of chemicals – one list of chemicals that have been shown to have a risk of causing cancer in animals or humans, and a second list of chemicals that have been shown to have a risk of causing birth defects or other reproductive harm in animals or humans.

Even if a chemical has not been shown to cause these kinds of harm in humans, if the harm has been shown in animal testing, then the State of California is required to put the chemical on the appropriate Proposition 65 list. The two lists, which are updated once a year, have grown to more than 800 chemicals since they were first published in 1987.

Proposition 65 also requires any company doing business in California to notify California consumers about the presence of a Proposition 65-listed chemical in any product the company is offering for sale in California.

If a product sold in California could expose a California resident to the specified minimum amount of one of these 800+ chemicals, then the product must include a warning notice. Proposition 65 does not ban the sale of a product that contains a listed chemical; it simply requires that the product have a “clear and reasonable” warning notice on it.

What Kinds of Chemicals Are on the Proposition 65 Lists?

The two Proposition 65 lists encompass a wide range of both naturally-occurring and man-made chemicals. Listed chemicals include ingredients found in pesticides, insecticides, and construction materials, as well as ingredients in common household products like foods, drugs, and alcoholic beverages.

Proposition 65 applies to all consumer goods sold in California, including food, although naturally occurring chemicals that are in food are not counted for purposes of determining if a warning notice is required. Since 2013, as a result of litigation to determine their status, dietary supplements are categorized in California as foods for purposes of Proposition 65.

Some chemicals on the two Proposition 65 lists, such as lead, cadmium, and arsenic, are naturally found in the environment, literally all over the world. Therefore, some products that naturally contain these chemicals can be required to carry a Proposition 65 warning notice, although, as noted above, not in the case of foods.

Are All States Affected by Proposition 65?

Proposition 65 only applies in California. Manufacturers, distributors, and retailers who sell consumer goods in California are subject to Proposition 65’s warning notice requirement, whether or not the company is located in California. However, it is certainly possible that a product originally intended for sale in California that has a Proposition 65 warning notice on it could find its way to another State and be offered for sale there, even though Proposition 65 doesn’t apply in that State.

Does Proposition 65 Apply to Dietary Supplements?

Proposition 65 does apply to dietary supplements sold in California. If a dietary supplement contains a chemical on a Proposition 65 list, and the chemical is present in an amount above its Proposition 65 threshold – and the chemical is not naturally occurring in an ingredient in the dietary supplement – then a warning notice must be on the product to inform California consumers the chemical is present.

Are Products with a Proposition 65 Warning Notice Unsafe?

When a manufacturer includes a Proposition 65 warning notice on a product it does not mean the product is unsafe. Rather, the notice is intended to inform California consumers of the presence of a listed chemical so the consumer can make an informed decision when purchasing the product.

How Concerned Should I Be about a Proposition 65 Warning Notice?

A bit of background information is needed to understand what Proposition 65 warning notices really mean. It’s important to understand that a Proposition 65 warning notice does not mean a product is dangerous or harmful. The threshold exposure limits that the State of California has set for many chemicals on the two Proposition 65 lists are far below the “safe” limits set by other regulatory agencies, such as the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, various European health agencies, and the World Health Organization.

For example, for lead, for children under the age of six, the U.S. Food and Drug Administration has established the “provisional total tolerable intake level” at six micrograms of lead per day. Consuming less than this amount of lead daily is an amount the U.S. Food and Drug Administration deems to be safe for children in this age group. By contrast, Proposition 65 requires a warning notice on any product that provides 0.5 micrograms of lead daily – an amount 12 times lower than the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for daily lead consumption in a six-year-old. For pregnant women, the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for lead is 25 micrograms daily, which is 50 times greater than the amount requiring a Proposition 65 warning notice. Finally, the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for non-pregnant adults is set at 75 micrograms of lead daily, which is 150 times greater than the amount requiring a Proposition 65 warning notice in the State of California.

How Does Proposition 65 Determine the Threshold Levels for Which a Warning Notice Is Required?

Proposition 65 establishes two criteria to define the level of exposure risk. One criterion applies to cancer risk and the other criterion applies to the risk for birth defects or other reproductive harm:

  • The maximum daily exposure threshold for a cancer-risk chemical is determined using the “no significant risk level.” The “no significant risk level” is defined as the maximum daily level of exposure that would result in not more than one additional case of cancer in 100,000 individuals exposed to that specific chemical every day for 70 years. In other words, a person who was exposed for 70 years to the maximum daily limit of the chemical at the “no significant risk level” would have no more than a one-in-100,000 chance of developing cancer as a result of that 70-year exposure.
  • The maximum daily exposure threshold for a birth defect-risk chemical is determined using the “no observable effect level.” The “no observable effect level” is defined as the maximum daily level of exposure that has been shown to not cause any birth defects or reproductive harm in laboratory animals or humans. In addition, as a margin of safety, the “no observable effect level” is divided by 1,000 to establish the threshold for requiring a Proposition 65 warning notice for that chemical.

How Do I Know That a Product Has a Prop 65 Warning Associated With It?

The product will have the Prop 65 warning label (see below) associated with the specific ingredient it applies to.