Proposition 65 and the Supplements Industry
Dietary supplements are used by millions of consumers every day to assist in improving their health. The vast majority of companies producing supplement products go to great lengths to ensure the products are wholesome and safe. Yet in 2018, the number of companies/products targeted for alleged non-compliance under California Proposition 65 doubled to ~150 compared to 2017. The primary chemicals targets were heavy metals, such as lead, cadmium, arsenic.
Why the high frequency of allegations against supplements?
The biggest factor is likely the fact that heavy metal purity limits are not explicitly defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) or current Good Manufacturing Practices (cGMP). It is up to the individual companies to make a determination of what contaminants might be present and set appropriate limits that ensure their specific products are safe. As such, different products may have slightly different limits. Companies may therefore be compliant with the over-arching requirements of the US FDA, but run into issues with Prop 65. Under this regulation there are specific limits in most cases, but based on daily exposure (not concentration limits in products).
Other factors include:
1) Exposure is undeniable and occurs on a daily basis. Unlike consumer products that have complex exposure pathways (how much is someone touching this product? how much chemical might actually come out? is the chemical absorbed? etc.). Dietary supplements are ingested and exposure is nearly guaranteed. Therefore, even for very small concentrations in products, it greatly simplifies the equation regarding “exposure” under Prop 65.
2) In some cases, heavy metals that are naturally present in soils, plants, and other materials, can make their way into certain supplements. The discussion regarding Prop 65 exemptions regarding “naturally present” will require a separate post (stay tuned!).
3) Products are readily accessible for purchase by bounty hunters (online and retail outlets) and heavy metal testing is relatively inexpensive.
4) It is very lucrative to enforce Prop 65 (see our post on the potential costs) so it creates a real incentive to look everywhere for alleged violators.
What can you do as a company to help mitigate the risk of enforcement action?
Ensure that products have the lowest possible heavy metal limits/ specifications that are reasonably feasible and can be consistently maintained. But it should be noted that there may be other Prop 65-listed chemicals that may be relevant to your product! A review of the raw materials may be necessary to ensure none of those ingredients have higher than anticipated limits. If they do have high limits, further investigation may be needed. Can the supplier provide more refined limits? Or might it be worth finding another supplier?
Testing of several samples from different batches will help confirm whether the product consistent meets the necessary specifications.
Even with these limits established, you should calculate whether daily exposure under daily recommended intakes at the specification limit does not exceed the Safe Harbor Level (SHL) for that chemical. Even if the limits are set as low as possible, exposure may still exceed SHL, which means warnings are required (or face potential enforcement action).
Heavy metals are ubiquitous contaminants that can show up throughout your supply chain and Prop 65 is a regulation that requires specific attention in order to avoid costly enforcement action (compliance with other regulations does not mean you are compliant with Prop 65).
A proactive approach is the best defense. It is critical that companies act now before being targeted – RegTox provides comprehensive and affordable solutions. Reach out to our experts to learn how we can help.