Prop 65 for FDA-regulated Products

Helping companies comply with FDA regulations is our specialty.  But FDA is not the only regulatory body our clients need to be aware of.  As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success for FDA-regulated products.  This post is from Dr. Derek Drechsel, a toxicologist with CTEH and the topic is California’s Prop 65 regulations.  Unfortunately, many FDA-regulated companies do not learn about these rules until they are sued.  The information below is to help you avoid that sort of surprise.

What is Prop 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65 (Prop 65), requires businesses operating in California to provide warnings about exposures to chemicals or substances that may cause cancer and/or reproductive and developmental toxicity. The California Office of Environmental Health Hazard Assessment (OEHHA) administers the Prop 65 program and has listed over 900 chemicals to date for consideration. Prop 65 states that a warning is required for these chemicals unless it can be shown that a significant exposure does not occur under reasonable use. To determine what entails a significant exposure, OEHHA has established safe harbor levels for cancer (No Significant Risk Level or NSRL) or developmental and reproductive harm (Maximum Allowable Dose Level or MADL). A business is exempt from Prop 65 warning requirements if demonstrated that exposure to a chemical occurs at or below safe harbor levels.

Penalties for failure to comply with Prop 65 can be substantial, with fines for violations up to $2,500 per day. In addition, according to the California Attorney General’s office, businesses spend millions of dollars ($35 million in 2018) to settle Prop 65 lawsuits. Hundreds of notices are filed with the Attorney General office each month. While the original act was intended to protect the state’s drinking water supplies, the impact of Prop 65 has grown to affect manufacturing and construction industries as well as foods, personal care cosmetics, and consumer products. Common chemicals targeted in notices include lead and other heavy metals (cadmium, arsenic), acrylamide, phthalates, hexavalent chromium, and formaldehyde. While other emerging chemicals and new product categories are continually identified and targeted.

What can I do to protect against Prop 65 claims?

There are several pathways by which companies selling products or conducting business in California can address potential Prop 65 issues. The first is a pro-active approach to determine if a product contains a Prop 65 listed chemical. This can be achieved by a critical review of supply chain materials, product formulations, and manufacturing processes or performing appropriate analytical testing and exposure assessment to determine if a significant exposure may exist. By identifying a potential issue, steps can be taken to reformulate or substitute for the chemical or substance of concern, where possible, or comply with Prop 65 warning requirements. Additionally, regular monitoring of Prop 65 notices, trends, and guidance published by OEHHA can be useful. The purpose of a pro-active approach is to identify and address any potential issues, avoid any future claims or violations, and be prepared to respond to any alleged claims.

In the event that a business receives a notice of violation from a private party, there are several steps they may take to assess the validity of the claim. First, one may contact the notifying party to ask for any relevant information to support the claim. However, it should be noted that the notifying party is not required to provide any such information. Second, one should conduct a scientific evaluation to determine if the claim is valid. This may include (1) laboratory testing of the product to determine the presence and concentration of the chemical or substance at issue, and/or (2) an exposure assessment to compare potential exposure from reasonable use of the product to the safe harbor level. Using proper methodology based on current scientific standards and Prop 65 guidance is critical. For this reason, one should ensure that an analyst and/or scientist experienced in Prop 65 issues are involved in the process.

What Are Some Challenges in Addressing Prop 65?

Of the over 900 chemicals currently listed under Prop 65, hundreds do not have safe harbor levels (NSRL or MADL) established by OEHHA. This presents a challenge to businesses determining warning exemptions or addressing notices of violation for such chemicals. However, experienced scientists can review relevant toxicology information to derive safe harbor levels for such chemicals in accordance with Prop 65 guidance, thus allowing businesses to conduct risk assessments to evaluate potential warning requirements in the absence of established levels.

Another common issue is related to “naturally-occurring” chemicals, or those chemicals that are naturally found in the environment and not intentionally added to a product. Heavy metals, such as lead, cadmium and arsenic, are listed under Prop 65 with stringent safe harbor levels. This creates a particular challenge to manufacturers and distributors of foods and nutritional supplements since soil and water naturally contain these metals. Prop 65 regulations contain a naturally-occurring exemption, although application of this protection has proven difficult and costly to parties attempting to do so. Scientific expertise and knowledge of precedents set forth by OEHHA for specific chemicals and/or products are essential to address such issues.

Am I exempted from Prop 65 Warning Requirements?

Demonstrated exposure below safe harbor levels and the naturally-occurring exemption are two of several means that manufacturers and distributors may be relieved from Prop 65 requirements. For a complete list and answers to frequently asked questions related to Prop 65, one should visit the CA Attorney General Office website.

CTEH scientists have extensive professional experience evaluating potential health hazards and conducting human health risk assessments for numerous commercial and consumer products, including applications to prepare for and respond to Prop 65 issues. For more information on CTEH’s capabilities, please contact Dr. Derek Drechsel.

Contact us with any questions.

Stay well!

You Might Also Like

Compliance Simplified

We'll help you cut through the red tape.