Posted by Patrick Sullivan Jr. (CEO & Co-founder of Jigsaw Health) on January 31, 2017
IMPORTANT UPDATE: Good news!! All Jigsaw Health products are now below the CA Prop 65 threshold. Why? Prop 65 guidelines changed in late 2017, and there is no longer an established level of inorganic arsenic that might cause reproductive issues. Therefore, this warning is being removed from all Jigsaw products as we print new labels.
PS - The rest of the original article that follows (posted in January 2017) is still an interesting discussion on the strangeness that is CA Prop 65 regulation.
-Patrick Sullivan Jr.
CEO & C0-Founder of Jigsaw
“Why do some Jigsaw Health products have a California Prop 65 warning on them?”
If you are on this page, it’s likely you saw a warning on one of our products, and you are now concerned for your safety.
That fear is quite understandable because if you live outside of California, you probably don’t know that these “Prop 65” warnings are found virtually everywhere in California, including Disneyland:
Therefore, most Californians have come to regard CA Prop 65 as “much ado about nothing”, which is probably really disappointing for the voters who passed this law in 1986, filled with good intentions.
At over 2,000 words (about a 15 minute read), the following article is fairly lengthy.
But I strongly encourage you to read the whole thing to better understand the ins and outs of this nuanced government regulation placed upon the rest of us by the State of California.
Let’s start at the beginning...
“What is the California Proposition 65 (aka. Prop 65)?”
Officially named the “Safe Drinking Water and Toxic Enforcement Act of 1986”, Prop 65 is a law that requires vendors selling products in California to warn consumers in California if a product contains certain chemicals.
The State of California maintains two lists of chemicals: those that the State of California has determined carry risk for birth defects or reproductive harm; and those that the State of California has determined carry risk for cancer in animals or humans.
Combined, these two lists include over 800 chemicals.
“What Prop 65 chemicals are in Jigsaw Health products?”
We test all our finished products at independent, third party labs. And we post tests results publicly on each product page so customers know what’s on the label is in the bottle. (Btw, we strongly encourage all other dietary supplement companies to do the same.)
Those lab tests revealed trace amounts of inorganic Arsenic in the following products:
If inorganic Arsenic is higher than .100 PPM (Parts Per Million) per daily serving, the State of California requires the Prop 65 warning on the label.
(FYI...the Prop 65 warning is also on Jigsaw Basic™, Jigsaw Complete™, Jigsaw Ultimate™ because Magnesium w/SRT is included in those packets.)
“What is Arsenic?”
Remember back in High School Chemistry when you had to memorize the Periodic Table of Elements?
Arsenic is one of those elements. And it is ubiquitous to our environment; in soil, sediment, and water. (See "Arsenic Fact Sheet" by The Centers for Disease Control and Prevention.)
Therefore, it’s no surprise that Arsenic is found in trace amounts of virtually every product that comes from the earth (such as minerals), grown in the soil (vegetables, herbs, etc.), or comes from the ocean (fish, kelp, etc.)
“Do other Dietary Supplements have a similar issue?”
In a word, Yes.
To quote fellow dietary supplement company, Designs For Health (Prop 65 Statement):
This issue affects all companies that make nutritional [dietary] supplements. The fact that some companies selling in California are not adding warning labels to their products does not mean their products are free of lead [or arsenic, etc.] Some companies may not be aware of the law; some have apparently chosen not to comply; still others have been sued or are currently in litigation with the state of California regarding their failure to comply with the law.
Jigsaw Health stands alongside other popular dietary supplement companies -- Thorne Research (Prop 65 Statement), NOW Foods (Prop 65 Statement), Seeking Health (Prop 65 Statement), Douglas Labs (Prop 65 Statement), Jarrow Formulas (Prop 65 Statement), American BioSciences (Prop 65 Statement), and many, many others -- in complying with CA Prop 65.
“So, are dietary supplements with a Prop 65 label unsafe?”
Well...I’ll offer my opinion.
While Prop 65 was certainly well-intentioned -- who doesn’t want to limit their intake of these chemicals? -- critics argue that one of Prop 65’s major flaws is the “safety threshold” that triggers the placement of the Prop 65 warning on a product or place of business.
Btw, this next part is tricky, so read carefully...
According to The California Office of Environmental Health Hazard Assessment (OEHHA), Prop 65 in Plain Language:
For chemicals [such as inorganic Arsenic], the “no observable effect level” is determined by identifying the level of exposure that has been shown to NOT pose any harm to humans or laboratory animals. Proposition 65 requires this to be divided by 1,000 in order to provide an ample margin of safety. Businesses are required to provide a warning if they cause exposures to chemicals that exceed 1/1000th of the “no observable effect level.”
In other words, if scientific literature shows that exposure to 100 PPM (Parts Per Million) of inorganic Arsenic per day is safe (ie. has “no observable effect”), then just to be extra cautious, they added in a 1/1,000 margin of error.
Yes, you read that right.
Therefore, if a product contains more than .100 PPM per daily serving, California makes businesses like us who use minerals that come from the Earth add this scary Prop 65 warning on our packaging.
And if you don’t have the warning, they sue you.
Various critics (obviously) complain that 1) the 1/1,000 safety margin was created arbitrarily, without scientific basis, and 2) it is now so low that it has led to Prop 65 warning signs to be placed virtually everywhere in California, including Disneyland.
Secondly, California unintentionally created what website Prop 65 Scam best describes as a “National Burden.” Because of the logistical complexity and cost of trying to create separate inventory only to be sold in California (or risk being sued), consumers outside of California are now freaking out when they see the Prop 65 label, meanwhile everyone inside of California could care less because they see the label virtually everywhere.
“Why not just remove the Prop 65 ingredients from the product?”
And if it were possible, Jigsaw Health -- and all other responsible businesses -- would just do that.
My guess is that most companies have worked to develop methods to further purify raw material sources in order to have them come in under Prop 65 warning levels. And for that, Prop 65 is to be praised!
As Grant Lundberg, CEO of Lundberg Family Farms, wrote in this statement about Prop 65,
“We’re committed to doing anything and everything we can to limit the amount of arsenic -- and any other chemicals for that matter -- from getting into our rice…”
It's not like people are walking around sprinkling in a pinch arsenic here, a smidgen of lead there...
These chemicals are found in Nature, and they are going to show up in products made from, and grown in, Nature.
The human body (with a healthy liver) has been filtering them out for millennia.
As the CEO of Jigsaw Health, I’ll add a personal note and say that it’s very painful to be required to place this statement on the side of a few of our products.
“WARNING: Consuming this product can expose you to chemicals including arsenic, which is known by the State of California to cause birth defects or other reproductive harm.”
Makes me nauseous...
And yet the nuances of what is really going on can never be communicated on the label of a small bottle.
Thus, the purpose of this long article.
Please continue reading...
“Why do other Jigsaw Health products contain minerals, but not have the Prop 65 warning on the label?”
As previously stated, all Jigsaw Health products are tested by third party, independent labs for Arsenic, Lead, Cadmium, and Mercury, among other things.
(This is standard “Good Manufacturing Practices”, or “GMP.” And we publish the results publicly on each product page as part of our Label Claim Verified program. Again, we encourage all other dietary supplement companies to do the same as we believe the transparency builds trust.)
In the case of Jigsaw Health Essential Blend Multi-Mineral -- containing various minerals that come from the earth -- the 3rd party lab detected just .046 PPM of inorganic Arsenic per daily serving.
Since the threshold for inorganic arsenic is .100 PPM, this product falls below the Prop 65 threshold… BUT IT STILL CONTAINS A LITTLE BIT OF ARSENIC!!
Herein lies the great irony of Prop 65’s arbitrarily chosen 1/1,000 “safety threshold.”
Some products contain Arsenic, but not enough to trigger the Prop 65 warning.
Yet consumers are led to believe, “Warning on label = DANGEROUS; No warning on label = SAFE.”
And thus, Prop 65 has -- in my opinion -- caused mass confusion for consumers without really enabling anyone to better protect themselves.
(Btw, Jigsaw’s lawyer is going to cringe while reading this article, but especially so when she reads that last section...she’ll tell me, “Patrick, you can’t thumb your nose at the regulators.” To which I’ll reply, “Well, we’re in compliance with the regulations -- and thus, there is no basis for them to file a lawsuit against us -- but that doesn’t mean I have to pretend to like the regulations.” Or as American BioSciences Inc. stated so diplomatically, “[We do] not object to compliance with Prop 65 despite [our] position that the required labels are misleading rather than informative.”)
Which leads me to my next point...
“Is Prop 65 going to change?”
If you’ve read this far, you can clearly see that I’m not a fan of Prop 65 as it stands today.
But… I am an optimist! :)
And I believe in the “two sides to every coin” principle.
So here’s the flipside: The more that companies of all types (dietary supplement makers, farmers, manufacturers, etc.) begin to comply with Prop 65, the more that consumers around the country (and the world) will get educated on Prop 65, and then (hopefully) demand meaningful improvements to this well-intentioned, but seriously flawed law.
“The road to hell is paved with good intentions.”
- Saint Bernard of Clairvaux
“Do the best you can until you know better. Then when you know better, do better.”
- Maya Angelou
To that end, various dietary supplement industry associations ( Council For Responsible Nutrition, Natural Products Association, Alliance for Natural Health, etc.) have been advocating for positive change on behalf of industry and consumers.
I’m hopeful that someday, we’ll find a happy medium.
On a personal note...
Remember, I myself use Jigsaw Health products every day. Almost no one in the solar system has ingested more of these than I have. So I have clear motive to make each of our products as pure as possible. And I do it gladly, for both of us.
If you have questions, please leave a comment below, send me an email (email@example.com), or call me on my cell phone, 480-221-5051.
Patrick Sullivan Jr.
CEO & Co-Founder of Jigsaw Health
PS - Two other things I find strange about CA Prop 65 that are worth mentioning:
External Links to learn more about Prop 65: