You’ve come to this website most likely because you’ve seen the warning above in one or more forms on a product.
WhyThisWarning.com will give you a quick overview with the answers to 10 basic questions of why and more information if you desire or require it.
In a nutshell, the cancer or reproductive harm warning that you see on many products is a result of Prop 65. Prop 65 or Proposition 65 is a California only law that requires a warning on many products and business locations.
These Basic Questions and Answers should educate you and about Prop 65 and the Prop 65 warnings on products that you buy and use.
Question 1:But I’m not in California and if Prop 65 only applies to CA businesses, why is the warning on a product in my state?
A: California is the most populated state in America with one in eight Americans living in California. The warning is only required on products actually sold or delivered in California. Many companies produce separate labeling for CA that contains the warning but for many products that are sold to national distributors or chains, it is very difficult to separate product for CA only. Therefore to eliminate the possibility of a product intended for a state other than CA ending up in CA, many product manufacturers simply include the warning on all products sold in the U.S.
Question 2:I see the warnings on many supplements, herbal products and cosmetics from many different companies. Why is this warning on supposedly healthy products?
A: You are familiar with the fact that CA requires cars to have a different emissions standard than the Federal Government. Cars that are legal in every other state are not legal in CA unless modified to meet CA emissions standards. Prop 65 imposes a very similar but much stricter standard.
There are some common herbs if used in a product must carry a cancer warning. As of Dec 2016, goldenseal and some forms of aloe vera must carry cancer warnings. If you do an internet search on goldenseal and cancer, you will find a huge number of references that goldenseal helps to inhibit and heal cancer. The Sloan Kettering Cancer Center websites states concerning goldenseal, “Laboratory studies show that berberine, a compound in goldenseal, inhibits the growth of a variety of tumors in rats, but no clinical trials have been performed.” Prop 65 used the opinion of an organization based in France without exercising any discretion or judgment of its own, and without having reviewed or considered the scientific basis for the French organization’s decision. Certain forms of whole leaf aloe vera are on the Prop 65 list and if you have a product with that aloe vera, a cancer warning must be listed. Yes, certain aloe vera and goldenseal require cancer warnings on the product if sold in California.
With herbal and supplement products, in over 90% of cases, the chemical in question is lead. Since lead is the most common chemical (actually lead is an element but for Prop 65 purposes it is a chemical) this explanation will use lead as an example.
The Federal government has limits on safe exposure of lead. Soil is considered safe in play areas with 400 ppm of lead and 1,200 ppm in non-play areas. 50 ppm or less is considered uncontaminated soil. PPM is parts per million or micrograms (ug) per gram. It is important to understand soil lead levels especially when dealing with items that come from the soil because the lead content of the soil will affect the lead content of whatever is grown in that soil.
Let’s use national standards for bottled drinking water as an example. The limit is 0.005mg/l of lead. The medical recommendation for daily water intake is 8 glasses of water per day, which is approximately 2 liters. At the Federal lead limit for bottled water, this would be a daily intake of 0.01mg of lead. The Prop 65 limit is a maximum daily intake of 0.5ug (micrograms) before requiring a reproductive warning and a maximum daily intake of 15ug before requiring a cancer warning.
A: Many fruits, vegetables, and even drinking water naturally contain some levels of the substances administered by Prop 65. In many cases, the exposure limits required by Prop 65 are lower than what occurs naturally. Turnips, apples, artichokes, carrots, cucumbers, green beans, and spinach are just a few foods that can deliver chemical exposures in excess of Prop 65 limits. How does this happen? Lead, for example, is found in natural proteins, plants, and minerals. Not a lot, but a measurable amount because plants absorb metals and other trace chemicals from the soil in which they’re grown. Detectable levels don’t mean that the plant was grown in dirty, polluted soil.
The amount of lead naturally found in many fruits and vegetables grown in clean, uncontaminated soil may, and in many cases does, exceed Prop 65 limits. When the State of California conducted a soil-lead-uptake analysis of its own soil, from 70 different locations, they found that most vegetables averaged four times the Prop 65 lead limits. That’s why fresh fruits and vegetables with naturally-occurring lead are EXEMPT from Prop 65, and food producers are not required to provide Prop 65 warnings for these sorts of things.
Question 4:What main chemical causes the warning and where does it come from?
A: Over 90% of the Prop 65 cases involving supplement and nutritional products concern lead. Lead is a toxic heavy metal naturally found in mineral composition the earth’s crust. It does not usually occur naturally in drinking water, but can be present from the use of lead-based solder or lead pipes, or from a contaminated water source. Solder is the metallic substance used by plumbers to fuse or weld metal pipes together. Soft, acidic water is more corrosive and likely to dissolve lead from solder or pipes than hard water. Lead is also present in the air from automobile and industrial emissions, and may be found in food. In buildings and homes built before 1978, lead may be present in paint. The U.S. Environmental Protection Agency (USEPA) estimates that 20 percent of our total lead exposure comes from drinking water.
Prop 65 was originally introduced to protect us from drinking contaminated water. Lead exposure from water can cause premature birth, reduce birth weight, delay physical and mental development in babies and young children, and cause learning disabilities in children in general. Lifetime exposure to high levels of lead can potentially cause stroke, kidney disease, or cancer.
Question 5: Are all product batches with a Prop 65 warning above the Prop 65 limit?
A: There are many instances where particular batches of the same product are below the Prop 65 limit but due to the variableness of natural ingredients, there are some batches above the limit. To prevent the hassle of having different labels for different batches (plus this would be a nightmare for many stores and companies), most manufacturers simply choose to put the warning on all batches of a product if there is a possibility that a single batch might be above the limit. In the three product examples below, The Cleaner® because of the Bentonite Clay, is always above the limit but Male Drive® and MultiThin™ may be below the limit for some batches and above for others depending on the herbs. It is similar to trying to get fruit or vegetables that looks and tastes exactly the same each time and season. Natural products vary.
Question 6:What are product examples with ingredients that require a warning?
A: These are three examples of products with Prop 65 warnings
THE CLEANER ®
The Cleaner®: The Cleaner® is a detox product that you take twice per day for 7 days. The Cleaner® uses natural ingredients (even the capsules are veggie caps and The Cleaner® uses no animal products). The Cleaner contains Goldenseal and requires the cancer warning. One of the most effective natural detox ingredients is Bentonite Clay. Bentonite absorbs a wide range of toxins from the body and there simply is no substitute for the effectiveness and safety of Bentonite Clay. Bentonite Clay is a purely natural substance straight from the earth (it actually IS earth) but Bentonite contains from 25 to 30 ppm of naturally occurring lead. The Cleaner® contains many other herbs and ingredients but Bentonite Clay is in The Cleaner® at a significant level. With an ingredient such as Bentonite Clay in a product, it will always exceed the 0.5ug/day threshold for the reproductive warning.
MALE DRIVE ®
Male Drive® is a product for married men. It helps many of the areas that men over 30 need boosted such as cardiovascular health, workout stamina, testosterone, prostate health and sexual potency. Male Drive® contains all-natural herbs and is taken twice per day. Many of the herbs in Male Drive® have levels of lead that pushes two doses of Male Drive® over the limit. The daily intake is calculated for the entire day and if a product recommends more than one dose per day, the total number of doses must be used for the lead calculation. Male Drive® uses Black Walnut, a natural herb that has up to 6 ppm of lead. Saw Palmetto is the major herb used to strengthen the prostate and other health areas and the specs for Saw Palmetto is less than 3 ppm of lead. This means a batch of Saw Palmetto can contain 2.99 ppm of lead and still be within the specs from the producers of Saw Palmetto. Less than 3, 5 or 10 ppm of lead is a standard specification for many herbs. Remember the soil itself can be up to 50 ppm and is considered uncontaminated by the EPA. All herbs come from the soil. If the total daily intake from the product is over 0.5ug (0.5 ppm with a 1,000 mg daily dosage or 0.25 ppm with a 2,000 mg daily dosage) then the product must have the reproductive warning.
With many natural herbs having a specification from the growers of less than 3, 5 or 10 ppm it makes it almost impossible to consistently produce a natural herbal product containing certain herbs that meets Prop 65 specs.
MultiThin™ is a complete multi-vitamin with an herbal appetite suppression complex. With Anti-Aging and ingredients for achy joints, bone health, memory, energy, immune system and mental clarity MultiThin™ contains a wealth of natural and powerful ingredients. Bromelain (an anti-inflammatory ingredient derived from pineapples) has a specification of less than 5 ppm of lead. But the Prop 65 limit is 0.5ug per day for a product. A 5-capsule, 2,500mg dose is the equivalent of 0.55 ppm and is above the 0.5ug limit. Remember 1 ppm equals one mg per gram and you must base total daily intake from a product on the total amount consumed in a day. Many natural herbs are far beyond that limit even when well below the supplier’s specifications. With certain herbs, there is often little chance of producing many products with those natural herbs that are below the Prop 65 limit.
Oddly enough, most synthetic ingredients have extremely little or no lead.
Question 7: Do the warnings actually help the cancer rate or reproductive health?
A: To be brutally honest, the warnings haven’t helped much and may even be creating negative results in some cases. You see, Prop 65 requires warning labels or signage whenever exposure could cause more than “one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime,” there is no real way for consumers to understand their actual exposure risk. Thus, consumers can’t differentiate between real threats against those that just contain a Prop 65 listed chemical way below the safe harbor numbers.
You will often see a Prop 65 warning on products even when the chemicals are present at levels a thousand times lower than those considered safe by the FDA, EPA, and WHO. Even worse, this warning shows up even when those “chemicals” are naturally-occurring constituents of the soil the products were grown in.
It is extremely expensive for a small company to prove that a substance is naturally occurring, so it’s cheaper to print the warning. Californians are used to seeing (and ignoring) this warning everywhere — from apartment buildings and parking garages to the local coffee shop… and even the aisles of organic and natural retailers.
Acrylamide is another example and this chemical is one of the primary reasons Proposition 65 labels appear in California coffee shops. The chemical forms naturally in a number of foods once they are cooked and is present in products such as breads, cereals, cookies, potato chips, etc. But the chemical has only been shown to be a carcinogen at extremely high doses—you’d have to eat 182 pounds of French fries a day to reach the level of proven cancer-causing exposure. Who can resist some good French fries? So we eat fries despite it having a Prop 65 warning and we get used to the warning and end up picking up a product that may be actually harmful and has the warning sign but we pick it up anyway because we are used to the warning and hardly care.
Professor Marlow has an interesting take on all of this. Aside from pointing out what any company or individual caught up in a proposition 65 lawsuit already knows, i.e., that “the only winners from Proposition 65 are the attorneys who bring lawsuits,” he also pointed out some additional facts that are not so commonly known. Chief among these are:
Since Californians have been warned of possible carcinogens, one would expect to see a decline in cancer rates compared to those states that did not adopt similar right-to-know laws. In fact, no such decline exists.
There isn’t a single medical study that demonstrates any public health benefits of Proposition 65.
There is no evidence that proposition 65 has lowered cancer incidence among Californians.
Proposition 65 has been a bonanza for the bounty hunter law firms that drive such lawsuits using paid plaintiffs. Between 2000 and 2011 there were 2381 settlements that cost targets nearly $180 million – exclusive of plaintiffs legal costs and court costs.
Question 8:What are the penalties for violating Prop 65 and how is it enforced?
A: Prop 65 lawsuits can be brought by the California Attorney General or certain other public authorities, or by anyone who chooses to bring suit “in the public interest”
• Proposition 65 can impose a fine of $2,500 per violation per day.
• The average settlement cost is approximately $65,000.
• Fines and penalties are split between the state and the plaintiffs, but the real payoff is for the lawyers who file these suits, as they are virtually guaranteed to get their fees and costs paid by the companies they sue.
• Settlements involving large groups of manufacturers and retailers have been known to total in the million plus dollar range. Examples are the fishing tackle, faucets and diaper cream settlements all of which totaled over a million dollars.
Proposition 65 lawsuits are extremely lucrative for law firms. In 2013, businesses paid $17.4 million in Proposition 65 settlement payments. Of that total, a whopping 73 percent ($12.7 million) went to attorney’s fees.
In 2012, businesses paid roughly $22.5 million in settlements under Proposition 65—up from $11.8 million in 2007.
Between 2000 and 2010, businesses paid more than $142 million to settle Proposition 65 cases—a figure that does not include the amount paid from cases that actually went to trial. Almost $90 million or 68 percent of that settlement money went to attorney’s fees.
Over that time period, cases brought by the State of California (rather than citizen bounty hunters) only accounted for $21 million, less than 15 percent of all settlement money collected.
The civil penalty component of Proposition 65 was set up so that the law would pay for itself and wouldn’t rely on funding from the legislature. But now civil penalties only account for a small portion of the money collected under Proposition 65 lawsuits.
Analysis of a 2012 report from the California Attorney General’s office shows that when businesses opt to settle rather than taking the case to trial, attorneys’ fees typically constitute 70-80 percent of the total amount businesses pay. For a handful of law firms, Proposition 65 lawsuits represent the majority of their caseload, collecting millions of dollars through Prop 65 lawsuit settlements.
Question 10:What incidences lead to the passing of Prop 65?
A: Prop 65 became law through the California voter initiative process. It was never reviewed by the state legislature or signed by the governor, but instead was the result of a signature gathering and election campaign paid for by a small group of lawyers in 1986.
Prop 65, which is the Safe Drinking Water and Toxic Act of 1986 is made up of two components. The law requires two things…
1. The State of California to identify chemicals that could cause cancer, birth defects, or reproductive harm. The state compiles these chemicals on a list–that list now contains over 800 chemicals.
2. Businesses to warn consumers of any possible exposure to one of the chemicals on the list, regardless of amount or actual risk of exposure. Businesses must post signage and/or warning labels on specific products.
COMMONLY CITED PROP 65 CHEMICALS ARE…
· Acrylamide-commonly found in cigarette smoke and starchy foods such as French fries
· Arsenic- found in fish, rice and wine
· Benzene- found in sodas
· Cadmium- found in tobacco, cereal, potatoes and other vegetables
· Carbon Monoxide- found in beef and fish
· Chlorinated Tris- found in household products, baby products
· Formaldehyde- found in fruits, vegetables and meats
· Hexavalent Chromium- found in metals, steel
· Lead (over 90% of all enforcement actions)- found in water, food, fruits, vegetables
· Polychlorinated biphenyls (PCBs)- found in meat, fish, poultry
Since 2012, several ingredients found in cosmetics were added to the Prop 65 list including..
· Diethanolamine – commonly found in shampoo, soap, sunscreen, and self-tanning products.
· Cocamide Diethanolamine (Cocamide DEA) – commonly found in shampoos and liquid soaps, skin creams, including facial masks and shaving creams, and hairspray and hair treatments.
· Titanium Dioxide (Ti02) –commonly found in powdered cosmetics, make-up and skin care products, sunscreens, and acrylic nail systems.
WHO ADHERES TO PROP 65
Any company who produces, sells or distributes products in California must be in compliance to rules governing Prop 65. Even if the company is not located in California, if it ships products for sell to California, Prop 65 rules apply.
A company with fewer than 10 employees may be exempt from Prop 65 if their contracts with third-party retailers require them to indemnify the retailers for labeling or other violations.
WHERE YOU MAY SEE A WARNING LABEL
A warning label may be present on these products or products sold by these retailers among the many other products and companies…
· A business/ product has a “safe harbor” from Proposition 65 warning requirements or discharge prohibitions if exposure to a chemical occurs at or below these levels. These safe harbor levels consist of No Significant Risk Levels for chemicals listed as causing cancer and Maximum Allowable Dose Levels for chemicals listed as causing birth defects or other reproductive harm.
· Even when the chemicals are “naturally occurring”, a warning must be placed on the product in some cases.
· Don’t panic when you see a warning label on a product. That bottle of product may be under the Prop 65 limit, but another batch of the same product may be over the limit.
· The exposure levels that trigger a warning requirement have a huge safety factor built into them. For suspected carcinogens the exposure level that triggers a warning requirement is the “No Significant Risk Level” (NSRL), which is the level of exposure that would result in no more than one case of cancer in 100,000 individuals exposed to the chemical every day for 70 years. For suspected reproductive toxicants, the exposure level that triggers a warning requirement is the “Maximum Allowable Daily Level” (MADL), which is level at which no reproductive toxicity effects are observed in laboratory animals (the “No Observable Effect Level” or NOEL), divided by a 1,000 safety factor. So, the NSRL and MADL warning thresholds are not levels that if exceeded will cause illness or injury or increase the risk of illness or injury – rather, they are “safe harbor” levels for the manufacturer and retailer, so that if the exposure to average users is below the MADL and/or NSRL for the chemical at issue, then no Proposition 65 warning is needed for the product.
It is the divided by a 1,000 safety factor that causes so many products or businesses to have the warning. In other words, the Maximum Allowable Daily Level (MADL) is 1,000 times stricter or 1,000 times smaller than the No Observable Effect Level (NOEL).
SPEAK WITH YOUR PHYSICIAN
If you are concerned about your exposure to lead, speak with your physician about your blood lead levels. Here are examples of elevated lead levels…
· At levels above 80 µg/dL, serious, permanent health damage may occur (extremely dangerous).
· Between 40 and 80 µg/dL, serious health damage may be occurring, even if there are no symptoms (seriously elevated).
· Between 25 and 40 µg/dL, regular exposure is occurring. There is some evidence of potential physiologic problems (elevated).
· Between 10 and 25 µg/dL, lead is building up in the body and some exposure is occurring.
The typical level for U.S. adults is less than 10 µg/dL (mean (avg) = 3 µg/dL).
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