Dealing with Proposition 65 Compliance for Herbal Supplements Marketed in California13 May, 2014 By: John Waller, Blank Rome LLP, Jeffrey Richter
As a manufacturer of herbal supplements, you may already be familiar with California’s Proposition 65. That statute, which has been in existence for nearly 30 years, prohibits businesses from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual of the existence of such chemical. The penalty for violating Proposition 65 is $2,500 per day, per violation – and each sale to an individual consumer can be penalized as a separate violation.
However, you purposefully included only beneficial ingredients in your supplement and would never have knowingly included harmful ingredients. You therefore breathe a sigh of relief knowing that you can market your product in California without worrying about Proposition 65. Think again!
First, under Proposition 65, the threshold levels for chemicals known to cause cancer or reproductive toxicity are remarkably low – often a mere fraction of a microgram in a daily dose. For example, the maximum permissible daily dose of lead is 0.5 micrograms. If your supplement is recommended to be taken more than once a day, the permissible level in each individual dose is corresponding smaller, as it is the cumulative exposure each day that is considered. As a result, it does not take a great deal of a problem chemical to create a violation.
Second, and less apparent, many herbal ingredients used in supplements contain naturally occurring levels of chemicals known to cause cancer or reproductive toxicity. Lead, arsenic, mercury and many other problematic chemicals exist naturally in the soil and are often absorbed by the plant from which the herbal ingredient is derived. Furthermore, many herbal supplements are sourced from China and other areas of the world where coal is the primary source of energy and efforts to control the resulting pollution are minimal. Pollution from burning coal greatly increases the levels of lead, arsenic, mercury and other toxic chemicals in the herbal ingredients grown in those areas.
Proposition 65 is enforced by government agencies and, in certain cases, by private plaintiffs. If they detect the presence of a problem chemical in your supplement at too high a level, they will first notify you and then go after you.
What can you do to minimize the risk of your supplement being found to be in violation of Proposition 65? First, even if you do not believe that your supplement contains chemicals known to cause cancer or reproductive toxicity, you need to have a qualified laboratory analyze all of your ingredients to be certain. Unless the laboratory’s results unqualifiedly assure you that there are no Proposition 65 problems, you may need to either reformulate your supplement to eliminate the problem ingredients or find another source for the problem ingredients. Second, because of the wide variations in the levels of lead and other problematic chemicals in many herbal ingredients, you will likely need to rigorously test each batch of herbal ingredients that are incorporated into your supplement to ensure that any aberrationally high exposure batches are excluded from your production.