How Supplement Label Owners Can Protect Themselves Against Proposition 65?

Prop 65 notices range in price from $50,000 to $100,000 and some over $1.5 million! Many companies have been hit two or more times!

Check if You Comply – 60% Don’t!
At the same time RELAX! There is a solution to this problem… read on and I will tell you about it!

Proposition 65 is an extremely dangerous regulation that can harm your company if you are not prepared for it.

However unpleasant and costly,almost all companies settle because most people don’t go to court against the California Attorney General (AG). Legal advice is not cheap; in order to get a well-versed Prop 65 attorney to defend yourself you are looking at $675/per hour.

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 the Attorney General.

Prop 65 is Super Corrupt.

This proposition is completely out of touch when it comes to lead. It allows for 50 times less lead than the FDA. At the same time it has NO LIMIT ON MERCURY. In this way it unfairly targets unrefined natural supplements and favors drug companies that sell injectable medications containing mercury as preservatives.

Proposition 65 does not take into consideration that natural products contain heavy metals that have been assimilated by the plant.

You may have seen the following warnings in California. A version of this statement is now in every Whole Foods Store, Starbucks in California and at the Internet retailer iHerb.com – when your IP address indicates you are located in California.

Unfair For You; The Manufacturer.

Brick and mortar establishments like Whole Foods can post above notice in inconspicuous corners in their stores. You however, as a supplement manufacturer, have to place this warning directly onto your label, should your product not comply with Prop 65. You are obliged by law to put this warning on your label should your product not comply:

WARNING: “This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.”

Bad for the Consumer

Prop 65 creates fear and confusion and creates “warning overdose”. With so many warnings on labels consumers feel that they can safely ignore all warnings.

How are fines calculated?

Prop 65 rules stipulate fines of $2,500 per exposure per day. Should you be in violation with a single nutritional product that is packaged at 100 tablets/capsules per bottle and for which the daily dose is 1 capsule and you have manufactured 500,000 bottles per year for the last 3 years, then your liability is “only”: $375,000,000,000. That is a number no manufacturer can afford to pay, but it’s a starting point from which the bounty hunters will kick off their “negotiations.”

Generally the bounty hunting attorneys will seek to maximize returns without bankrupting you.

Who needs to follow this law?

All companies selling products that employ more than 10 people anywhere in the supply chain, including manufacturing, distribution, management and sales. This means that if you are a three-person company but you contract your manufacturing to a company that employs 10 or more people (including manufacturing, sales, labs, and administration), you are obliged to follow the regulation. If bounty hunters pick your product up, test it and find it does not 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 accordingly, or both.

Further if you sell to a large company like Whole Foods or Sprouts the bounty hunting attorney will send a notice to your customer. They will also send a notice to Amazon and or any platform you sell on and make them liable also. This can be very damaging.

What natural supplements tend not to comply with Prop 65?

Whole unrefined natural herbs – organic, regular and wild crafted especially if they originate from China and India.

Calcium and mineral supplements

Colloidal minerals

Fish oils

Vegetable oils

Protein powders

Some herbal extracts

Candy from Mexico

Over 60% of supplements with a daily dose over 500mg per day

California Proposition 65 Daily Limits for Heavy Metal Consumption

Lead 0.5 mcg (μg)

Arsenic 10 mcg (μg)

Cadmium 4.1 mcg (μg)

Interestingly there is no Prop 65 limit for Mercury! Corruption pays off nicely for the criminals at ADA, AMA and big pharma.

United States Pharmacopeia (USP) Limit for Nutritional Supplements

Lead 10 ppm

Arsenic 3 ppm

Cadmium 3 ppm

Mercury 3 ppm

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 = 8.200 ppm

Mercury = 0.600 ppm

Proposition 65 is extraordinarily unrealistic regarding lead intake and is nowhere near the limits other regulations call for, including FDA and USP limits for the same elements. This is a specific attack on 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.

How to avoid Proposition 65 Notices!

I told you to RELAX! There is no reason for you to receive a Proposition 65 Notice!

You can easily avoid such unfortunate financial distress by testing the levels in your raw materials and/or finished goods and by restating your dosage to safe levels as far as Prop 65 is concerned.

Know what to measure!

Over 96% of all enforcement are due to lead being over the Prop 65 limit. Focus your attention to lead!

Know how to measure the levels!

Send your product to a lab and have it tested for lead, arsenic, cadmium and mercury.You will get your results in one of the following units: mg/kg, mcg/kg, μg/kg or ppm. Know that μg = mcg and that ppm = mg/kg. Go to endmemo.com for your conversions.

Know that you are liable if your product can end up in California!

Even if you don’t live in California you can still be sued by CA Attorney General. How? If you sell your product online you cannot prevent people in CA to purchase your products. If you sell to a distributor you lose control of where your products end up but you are still liable.

Lower your dosages

Don’t indicate more than a dose of 1 capsule/tablet if the product contains herbs or other products of concern.

Should you be selling herbal capsules you could indicate under dosage that people should pull the capsule apart and consume fractions of 1 capsule. You could also call it a spice capsule and indicate that 1 capsule was enough for a family of 6 people.

Should you sell powdered herbs be careful to indicate no more than 1/8th of a teaspoon as a dosage. To be extra safe indicate 1/64th of a teaspoon!

If you are selling herbs to be used as tea then indicate that on label. Exposure is calculated on “contaminants” in the hot water and not the herbs they throw away. This may safe you in some cases from Prop 65 fines.

If your herbs are for baking then indicate for each dosage is for a family of 6 to 10 people.

Again always have your product tested for lead. Then calculate the level of contaminants for lead, arsenic and cadmium.

Remember 96% of notices are about the unreasonable low level of lead permitted by Proposition 65.

Select a contract manufacturer that will inform you and work with you!

Any contract manufacturer that does not inform you of the possible harm that can come to you from Prop 65 is doing you a disservice.

Know that you are always ultimately responsible for your own label!

Most contract manufacturers are aware of this danger by now and protect themselves with the following language in “Terms and Conditions”, as we do at PureNSM:

“It is up to Buyer to calculate levels of contaminants in daily dose stated on the label and to make sure such dose meets California Proposition 65, should goods be offered for sale in the USA. Seller is to adjust dosage and change labels to comply with Prop 65. Buyer bears sole responsibility to meet Proposition 65 rules. Should Contaminants not meet Prop 65 Buyer certifies that they will label all products sold to the state of California with a sticker reading “WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.”

Buyer will make sure that the dose they recommend will not cause overdose or adverse reactions in individuals, including but not limited to vitamins that accumulate in the body.

Buyer will include all appropriate and/or legally required warnings on labels and supporting websites and literature with regard to concerns of side effects/adverse reactions.”You can find our entire Terms and Conditions on our website under the link “Click Here for Terms and Conditions” in the footer.