How to protect yourself from Proposition 65
In 2011 to 2012 over 300 Supplement Manufacturers received Prop 65 Notices, requiring manufacturer to pay fines, often over $100,000 and some over $1.5 million.

I don’t know if you have heard about Proposition 65, but its a real dangerous regulation that can harm your company if you are not prepared for it.

What is Proposition 65?
Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in California in 1986. The regulation stipulates that private parties enforce the regulation with the help of Attorney General.

Unfair and Unrealistic Proposition
As you can see below, proposition 65 is completely out of touch and has a safety limit 50 times more stringent than FDAs safety limit. Unfortunately it does not take into considerations that natural products contain heavy metals that have been assimilated by the plant and rendered harmless. The results is that the following holds true:

WARNING!

Everything in the State of California Contains Chemicals Known To Cause Cancer or Developmental or Reproductive Harm.

A version of this statement is now in every Whole Food Store, Starbucks and at the internet retailer iHerb.com. It’s coming to your product as well!
















Unfair for the Supplement Manufacturer
Establishments like Whole Foods can post this notice in a inconspicuous corner in their establishments. You however, a supplement manufacturer, have to place this Scary Warning directly onto your label if you don’t comply with Prop 65.

Bad for the Consumer
As a direct result of complying with Prop 65 companies have now stopped selling wholesome unrefined herbs. Manufacturers now also state lower daily doses on the product, much less than is effective. Finally Prop 65 creates fear and confusion and dilutes other warnings – this causes consumers direct harm because they now have a “warning overdose” and now ignore all warnings.

New Industry
Because this proposition was designed to be enforced by private parties it has caused a new highly profitable industry to sprout, “The Proposition 65 Bounty Hunter Lawyers” that now operate under a ““Not For Profit Environmental Companies” that threaten food, supplement, and candy manufacturers with fines of $2,500 per exposure per day. This results in millions in “revenue” for the bounty hunters of which the AG office receives a cut.

A bounty hunter is an individual who seeks out fugitives (‘Hunting’) for a monetary reward (‘Bounty’) for apprehending by law, if such laws exist.(In lawless areas, bounty hunters still exist, and are, indeed, even more common.)
-Definition from Wikipedia, the free online encyclopedia

How does Proposition 65 apply to supplement manufacturers?
In 2011 and 2012, over 300 supplement manufacturers received notice of Proposition 65 violation. Many have paid over a million dollars to the bounty hunters that act as private plaintiffs. Smaller manufacturers are also vulnerable, many of those are estimated to have paid over $100,000 each. No One is immune to the extortions. Even foreign companies have paid and had to withdraw products from Wal Mart.

Your failure to protect your company can directly lead you to bankruptcy. If you have a hand in Quality Control and do not protect your company — you may lose your job, and you should, because even if the Prop 65 is unfair, it’s a regulation that the Attorney General is obliged to enforce. It’s your job to protect your company. Read on and learn how to.

Failure to comply with Proposition 65 can lead to huge financial penalties. Prop 65 can impose a fine of $2,500 per exposure per day. Should you be in violation with a single nutritional product that is packaged 100 capsules per bottle and for which the daily dose is 1 capsule and should you have manufactured 500,000 bottles per year for the last 3 years then your liability is: $375,000,000,000. That is a number most manufacturers cannot afford to pay but it’s a starting point the bounty hunters will start their “negotiations” with.

Who needs to follow this law?
All companies selling products that that employ larger than 10 people anywhere in the supply chain, including manufacturers, distribution, management, and sales. This means that if you are a three people company but you contract your manufacturing to a company that employs 10 or more people (including manufacturing, sales, labs, and administration), then you are obliged to follow the regulation. If bounty hunters pick your product up and test it and find it not to comply with Prop 65 you will have to pay the negotiated fines and in addition either label your product with a Prop 65 warning or adjust formulation and dosage levels, or both.

Don’t think you are at risk to loose your shirt on Prop 65?
Then go to www.iHerb.com and put in a few products containign herbs, fish oil, flax oil, calcium to mention a few and enter a Californian ship to address. The next thing you will see is a red Proposition 65 Notice about birth defects and cancer. iHerbs was one of the 300 companies that received the notice.

What pollutants are the “Prop 65 lawyers” measuring and issuing notices for?
Lead, arsenic, cadmium and mercury. Although any of the four can be high, lead is of highest concern because you are most likely to be out of compliance on lead.

California Proposition 65 Daily Limits for Heavy Metal Consumption

  • Lead 0.5 mcg (μg)
  • Arsenic 10 mcg (μg)
  • Cadmium 4.1 mcg (μg)
  • Methyl Mercury 0.3 mcg (μg)

If your label recommends one single daily dose of 500mg, the PPM in your product can not be higher than:

  • Lead = 0.900 ppm
  • Arsenic = 20.000 ppm
  • Cadmium = 8.000 ppm
  • Mercury = 0.600 ppm

Proposition 65 is extraordinary unrealistic on lead intake and is nowhere near the limits other regulations call for, including FDA and USP limits for the same elements in supplements.

FDA Tolerable Daily Diet Lead Intake
Children <6 yrs old 6 mcg (μg)
Pregnant women 25 mcg (μg)
Adults 75 mcg (μg)
Note: There is a revised FDA ruling: 0.1 ppm of lead in candy
likely to be consumed frequently by small children.

United States Pharmacopeia (USP) Limit for Nutritional Supplements
Lead 10 ppm
Arsenic 3 ppm
Cadmium 3 ppm
Mercury 3 ppm

How to avoid Proposition 65 Notices?
Routinely testing your supplements is the only way to avoid costly fines. Only by testing and adjusting your formulation accordingly can you avoid testing above the limits.

Of course you may also avoid Prop 65 by employing 9 or fewer employees. Or hire a contract manufacturer that employs fewer than 9 people, however if you do that please note that if you sell your products to a larger store that they will be liable and will stop purchasing your products when they get caught.