California law requires that some of Flora’s natural herbal products, like many other natural products, must be sold with the following notice in California:
Warning: This product contains chemicals known to the State of California to cause birth defects or reproductive harm.
What is this warning?
Sometimes you will see a product for sale that has a label with a warning along the lines of the following:
This product contains a chemical known to the State of California to cause cancer or reproductive harm.
You may also see this warning at the point of purchase at an online retailer or for a catalog item.
California has two different types of warnings – those for cancer and those for reproductive health effects. Some products have one or the other of these warnings and some products have both warnings. These warnings are required by California labeling law Proposition 65 (or Prop 65 for short), which is meant to notify individuals in California of exposures to Prop 65-listed chemicals. Prop 65 does not ban the sale of any products containing these chemicals; it only requires warnings.
What is Prop 65?
In 1986, the people of California passed a ballot initiative proposition, now commonly known as “Prop 65″, that was primarily designed to prevent dumping of toxic chemicals in California waters. However, it also required warnings on products that contain certain chemicals. The law is enforced solely by civil lawsuits, which may be brought either by public authorities or private persons. Although the law was well-intentioned, it has caused many unforeseen consequences. And because it was passed by a ballot initiative, avoiding the usual legislative process, it is difficult to change.
Prop 65 applies to any product or service received or used in California. As applied to foods, Prop 65 makes no distinction between natural and artificial products. And although it excludes “naturally occurring” chemicals in foods, that term does not include man-made pollutants that may end up in natural products through processes outside of the manufacturer’s control. Prop 65 does not distinguish between chemicals that result from natural phenomena like volcanic activity; chemicals that result from worldwide soil, water, and air pollution that are naturally absorbed by plants; those that are the result of local/regional problems like pesticide overspray or chemical leaks; those that are intentionally applied like synthetic fertilizers and pesticides; and those that are introduced later in drying, processing or manufacturing.
Prop 65 also does not limit in any way either the types or amounts of chemicals that can be put into a product, as long as the warning is given. Nor does the warning have to disclose the kinds or amounts of chemicals in the product. If the regulatory “safe harbor” warning is given, then the seller is deemed to have complied with the law. Businesses with less than 10 employees and products that are within certain “safe harbor” limits, described further below, are exempt from the warning requirements.
Does this law apply everywhere?
The “Prop 65” warnings are only required under California law. Prop 65 standards are among the most stringent standards in place anywhere and are often far more stringent than federal standards.
Are Flora’s products safe?
Yes, our products are safe and we follow current FDA and GMP regulations. Flora is also registered with the FDA bioterrorism act.
If Flora’s products are safe, why is there a warning about possible reproductive harm?
Prop 65, in the State of California, requires the state to publish and maintain a list of 800+ chemicals, including heavy metals, known to cause cancer, or birth defects or other reproductive harm. Prop 65 also requires businesses to notify Californians about the presence of these chemicals in their products if the chemicals exceed certain levels.
How do Prop 65 levels compare with other safety standards?
Various countries and safety organizations have reviewed known studies and science to produce safety guidelines on the levels of heavy metals that can be consumed on a daily basis without causing harm. The Prop 65 levels are among the most stringent, and again, build in a 1000-fold safety factor below the no observable effect level for chemicals listed as reproductive toxicants. For comparison, where Prop 65 allows for 0.5 mcg/day of lead, according to the AHPA, Canada’s Natural Health Directorate allows for 10 mcg/day, the FAO/WHO and EU allow for 20 mcg/day, and the ANSI 173 standard is 20 mcg/day.
How do the California warnings compare to federal limits?
It should be noted that California product label warning requirements are not usually the same as federal safety requirements. This causes a mismatch between warnings on products sold in California and what is required elsewhere in the U.S.A. So this can explain why sometimes you may see a California Prop 65 warning on a product sold in California but no warning on the same product sold elsewhere. The products are not different; it’s just that Prop 65 warnings are required for sales to California consumers.
Additionally, there are various substances that require a California Prop 65 warning at levels that are far more stringent than federal action limits. One example is lead. The Prop 65 standard for warnings for lead is 0.5 micrograms per day, which is far more stringent than federal and international standards for lead.
Why don’t all similar products carry the warning?
There could be a variety of reasons. The enforcement of Prop 65 has been inconsistent, and this sometimes explains why you will see certain products in the market with warnings, and virtually identical products without warnings. Other companies may elect not to provide warnings because, in their assessment, they conclude that they are not required to do so under Prop 65 standards. A lack of warnings for a product does not necessarily mean that the product is free of the same substances at similar levels.
Why did you decide to put the warning on the label?
Our aim is to provide you with the safest, most efficacious products available. We decided to place the warning on the bottle because the alternatives did not seem to serve you, our customer.
- Making changes to the formula or lowering the amount to be taken daily would make the products less effective.
- We did not want to remove our products from California as an alternative.
We hope that this information has helped you make an informed decision. Please know that Flora strives to manufacture and distribute only premium health products. Our award-winning supplements blend traditional wisdom and modern science by incorporating full-spectrum plant constituents and utilizing certified organic, non-GMO, gluten-free, soy- free, and kosher materials whenever possible.