California Prop 65 Warning
United States of America, State of California “Safe Drinking Water and Toxic Enforcement Act of 1986” more commonly known as Proposition “Prop” 65, explained
In 1986, California voters approved an initiative to address their growing concerns about exposure to toxic chemicals. That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65. Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987 (oehha.ca.gov).
In 1986, California voters approved Proposition “Prop” 65, the “Safe Drinking Water and Toxic Enforcement Act of 1986”.
Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment. By providing this information, Proposition 65’s intent was to enable Californians to make informed decisions about protecting themselves from exposure to these chemicals (oehha.ca.gov).
Businesses are required to provide a “clear and reasonable warning” before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or other published notices. The warning is required even if the listed substances are naturally occurring and even if the amount of the chemical in the product falls far below Food and Drug Administration (FDA), Environmental Protection Agency, and World Health Organization safe levels (oehha.ca.gov).
However, it is possible for a business to be exempt from this legislation if it is determined that there is “no significant risk” of exposure to the ~900 chemicals currently on “Proposition 65 List of Chemicals”. The “no significant risk level” is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000 chance” (0.001%) of developing cancer as a result of that exposure (oehha.ca.gov).
Many corporations that do business in California, including USANA Health Sciences, find the above legal definition of “no significant risk level” to be unjustly burdensome and difficult, if not impossible, to defend in a court of law. As such, many corporations—including USANA Health Sciences—prophylactically include or attach the Proposition 65 warning with/to their products sold in California.
“Many businesses have opted to include [Proposition or ‘Prop’] 65 warnings out of an abundance of caution to avoid liability under the statute without evaluating whether exposures to their products or facilities would be required under the statute.”
In the case of USANA, and specifically in the case of lead in USANA products, we believe the allowable lower limit of 0.5 micrograms, which would trigger the need to include a warning to be unduly and erroneously low for two major reasons. First, lead is a naturally occurring atom that can be found in some degree in nearly all food products that humans consume including fruits, vegetables, and cereal crops.
Lead is a naturally occurring atom found throughout the world’s food supply
At the bottom of this entry you will find a selected list of approximately 400 food items that the United States Department of Agriculture found to contain lead. Additionally, a study analyzing lead concentrations in fruits, vegetables, and cereal crops found in some cases lead to be present at levels greater than 1000 micrograms—over 2000-fold the Proposition 65 allowable level (Szymczak, J. et al. 1993).
One study analyzing lead concentrations in fruits, vegetables, and cereal crops found lead to be present at levels greater than 1000 micrograms—over 2000-fold the Proposition 65 allowable level—in some crops!
-Szymczak, J. et al. 1993
Second, the pharmacology (how lead is circulated and distributed throughout the body), toxicology (potential to cause acute/chronic poisoning), carcinogenicity (potential to cause cancer), mutagenicity (potential to mutate DNA), and teratogenicity (potential for birth defects) data for lead is equivocal at best. In toxicology studies the lowest observed toxic dose was between ~3000- to ~22,000-fold the Proposition 65 level. Regarding carcinogenicity, mutagenicity and teratogenicity, according to INCHEM a coalition of intergovernmental organizations including International Programme on Chemical Safety (IPCS), World Health Organization (WHO), Canadian Centre for Occupational Health and Safety (CCOHS), Inter-Organization Programme for the Sound Management of Chemicals, (IOMC), FAO, ILO, UNEP, UNIDO, UNITAR, OECD, and the World Bank states that:
- “The lowest reported lethal dose in man (LDL0) is 1470 µg/kg”. (INCHEM.org)
- “…evidence for carcinogenicity in humans is inadequate (IARC, 1987). Alkyl lead compounds have not been tested adequately: the evidence for carcinogenicity of organolead compounds in animals is inadequate (IARC, 1987)”. (INCHEM.org)
- “TEL [tetraethyl lead] and TML [tetramethyl lead] did not induce mutation in bacteria (IARC, 1987)”. (INCHEM.org)
- “No adequate animal studies exist of the possible teratogenic effects of lead (WHO, 1977)”. (INCHEM.org)
USANA understands that its customers want their products to be as “clean” as humanly possible and we strive to deliver on that promise. That is why USANA has—and will continue to—regularly test and monitor products to safeguard against potentially harmful contaminants including rejecting raw materials, vendors, or finished products when levels are found to be
unacceptably high. This includes lead, other chemicals on the Proposition 65 list, other harmful substances not on the Proposition 65 list, biological contaminants such as yeast, mold, and bacteria, and many, many other chemicals and contaminants. USANA complies with all laws and regulations governing product safety. These laws and regulations have always been, and will continue to be, of paramount importance to ensure USANA is providing its customers with safe, healthy, and beneficial health products.
Dr. Myron Wentz’ vision: “The USANA family will be the healthiest family on earth. Love life and live it to its fullest in happiness and health.”
-Myron Wentz, Ph.D. Founder and Chairman USANA Health Sciences, Inc.
Frequently Asked Questions
What is California Proposition 65 (Prop 65)?
Prop 65 is a California law. Specifically, it is part of the California Safe Drinking Water and Toxic Enforcement Act of 1986. It is a “right to know” statute that requires companies to post warnings on products containing any of the 900+ substances listed by the State of California as a cause of cancer and/or reproductive harm. Prop 65 does not ban the listed substances (lead, for example), it merely requires companies to provide “clear and reasonable” warnings before products are consumed. The substance most at issue in the supplements industry is lead.
The warning is required even if the listed substances are naturally occurring and even if the amount in the product falls far below Food and Drug Administration (FDA), Environmental Protection Agency, and World Health Organization safe levels.
Is this new? What has changed?
Prop 65 and the accompanying warning are not new, and USANA has not changed any product ingredients that would require the warning. USANA has actually provided the Prop 65 warning for a number of years on our website, which customers see during the checkout process. However, due to a recent change in the Prop 65 regulations, USANA is now required to provide the warning on the product label—not just on the website—and has adapted its product labels to provide the warning. The label change is only made to USANA products sold to California Associates, Preferred Customers, and retail customers. USANA Associates will also be prohibited by the Policies & Procedures from selling any applicable non-California products (which lack the Prop 65 warning) into California.
Which products are affected?
USANA’s Nutrimeal, MySmart, and Nutritional product lines have the Prop 65 Warning applied to them in California.
Why does USANA put a Prop 65 warning on their products?
We have decided to put the Prop 65 warning on our products in order to stay compliant with California law. We do not add lead to our products, but, as a mineral found in top soil, trace amounts can naturally occur in the plant-based botanicals and minerals we use in our products. The amount of lead in USANA products is, if any, only slightly above this level. We have made a business decision to provide the warning in an abundance of caution.
Under Prop 65, the warning must be provided if there is more than 0.5 micrograms/day of lead in products. This is far stricter than the levels accepted by other government agencies. By comparison, FDA’s Provisional Tolerable Total Dietary Intake level (PTTDI) for lead is 75 micrograms per day for adults.
The reality of Prop 65 is that many companies—USANA included—put the warning on their product for business reasons. Companies face fines of $2,500 per day per violation for failing to provide the required notice and risk being sued by Prop 65 lawyers. While most Prop 65 cases are without merit, they are extremely expensive to defend. Because of this, most companies find it more economical to display the warning, rather than run the risk of being sued and the cost of defending a lawsuit.
Are USANA products safe, even with the warning?
Yes, USANA products are safe. There has been no change to our product formulations and we take every reasonable step to ensure the safety, efficacy, and purity of our products. We stringently test for lead and other chemicals and have found them only in extremely miniscule levels, far below the FDA’s scientifically proven safe intake levels. In fact, most USANA products test at a hundred times less than this FDA safe standard. Remember, a Prop 65 listing is not a regulatory decision by California that any USANA product is unsafe.
We are world-renowned for our legacy of scientific excellence and innovation, source the highest-quality ingredients from around the world, and follow strict testing and quality assurance protocols. And we’re proud of this.
Prop 65 warnings have become commonplace in California and are found on the labels of dietary supplement and personal care products, on foods and in restaurants and stores, and even in amusement parks—Disneyland included.
Will this regulation affect my business?
The updates to Prop 65 will not affect your ability to do business in the State of California. As mentioned above, there has been no change to our product formulations, and this will not affect which products can be sold in the state. We are simply staying compliant with current state law. The Prop 65 warnings will soon be appearing on the labels of many products from our reputable competitors, so we do not view the warning as placing us at a competitive disadvantage in California.
We hope this information is helpful. If you have any questions regarding Prop 65 or our formulas, please feel free to contact our customer service or Ask the Scientist teams.
Is lead in other natural products?
Yes. Fruits and vegetables grown in the soil invariably contain trace amounts of lead. FDA studies have shown that the amount of naturally occurring lead in an adult-size serving of spinach is 5.2 micrograms—many times the Prop 65 level. If an adult consumes the USDA recommended 3-5 servings of vegetables a day, they would exceed the maximum level allowed by Prop 65 by 10 times. The amount of lead in USANA products is lower than the amounts in most raw, unprocessed fruits and vegetables.
Selected list of lead content in ~400 common foods:
|Food||Min (mg/kg) (ppm)||Max (mg/kg) (ppm)||Mean (mg/kg) (ppm)|
|Milk, lowfat (2%), fluid||0||0.008||0|
|Beef roast, chuck, oven-roasted||0||0.011||0|
|Ham, cured (not canned), baked||0||0.023||0.001|
|Pork chop, pan-cooked with oil||0||0.013||0.001|
|Pork bacon, oven-cooked||0||0.021||0.001|
|Lamb chop, pan-cooked with oil||0||0.015||0.001|
|Liver (beef/calf), pan-cooked with oil||0||0.023||0.001|
|Pinto beans, dry, boiled||0||0.011||0|
|Pork and beans, canned||0||0.011||0|
|Bread, white, enriched||0||0.011||0|
|Biscuits, refrigerated-type, baked||0||0.014||0.001|
|Bread, whole wheat||0||0.011||0.001|
|Noodles, egg, enriched, boiled||0||0.013||0.001|
|Corn flakes cereal||0||0.018||0.001|
|Fruit-flavored cereal, presweetened||0||0.01||0|
|Shredded wheat cereal||0||0.011||0|
|Raisin bran cereal||0||0.014||0.002|
|Crisped rice cereal||0||0.013||0.001|
|Oat ring cereal||0||0.023||0.001|
|Orange (navel/Valencia), raw||0||0.021||0.001|
|Pear, raw (with peel)||0||0.009||0.001|
|Fruit cocktail, canned in light syrup||0||0.025||0.011|
|Grapes (red/green), raw||0||0.019||0.001|
|Pineapple, canned in juice||0||0.046||0.009|
|Apple juice, bottled||0||0.007||0.001|
|Grapefruit juice, bottled||0||0.006||0|
|Prune juice, bottled||0||0.014||0.003|
|Spinach, fresh/frozen, boiled||0||0.018||0.004|
|Collards, fresh/frozen, boiled||0||0.025||0.002|
|Lettuce, iceberg, raw||0||0.017||0.001|
|Asparagus, fresh/frozen, boiled||0||0.009||0|
|Tomato sauce, plain, bottled||0||0.019||0.001|
|Green beans, fresh/frozen, boiled||0||0||0|
|Green beans, canned||0||0.01||0|
|Cucumber, peeled, raw||0||0||0|
|Summer squash, fresh/frozen, boiled||0||0.018||0.001|
|Pepper, sweet, green, raw||0||0||0|
|Squash, winter (Hubbard/acorn), fresh/frozen, boiled||0||0.012||0.001|
|Onion, mature, raw||0||0.014||0.001|
|Potato, baked (with peel)||0||0.012||0|
|Spaghetti with meat sauce, homemade||0||0.021||0.001|
|Chili con carne with beans, canned||0||0.016||0.002|
|Macaroni and cheese, prepared from box mix||0||0.046||0.002|
|Quarter-pound hamburger on bun, fast- food||0||0.024||0.001|
|Meatloaf, beef, homemade||0||0.024||0.001|
|Chicken potpie, frozen, heated||0||0.024||0.001|
|Soup, chicken noodle, canned, condensed, prepared with water||0||0.02||0.001|
|Dill cucumber pickles||0||0.049||0.009|
|Margarine, regular (not lowfat), salted||0||0.033||0.001|
|Butter, regular (not lowfat), salted||0||0.031||0.002|
|Mayonnaise, regular, bottled||0||0.031||0.001|
|Cream, half & half||0||0.024||0.001|
|Cream substitute, non-diary, liquid/frozen||0||0.016||0.002|
|Sugar, white, granulated||0||0.022||0.001|
|Ice cream, light, vanilla||0||0.01||0.001|
|Cake, chocolate with icing||0||0.021||0.007|
|Sweet roll/Danish pastry||0||0.019||0.004|
|Chocolate chip cookies||0||0.018||0.007|
|Sandwich cookies with creme filling||0||0.019||0.004|
|Pie, apple, fresh/frozen||0||0.013||0.001|
|Pie, pumpkin, fresh/frozen||0||0.015||0.002|
|Candy bar, milk chocolate, plain||0||0.027||0.013|
|Gelatin dessert, any flavor||0||0.01||0.001|
|Carbonated beverage, cola, low-calorie||0||0.013||0.001|
|Wine, dry table, red/white||0||0.029||0.007|
|BF, beef and broth/gravy||0||0.015||0.001|
|BF, chicken and broth/gravy||0||0.018||0.001|
|BF, vegetables and beef||0||0.007||0|
|BF, vegetables and chicken||0||0.011||0.001|
|BF, chicken noodle dinner||0||0.01||0.001|
|BF, macaroni, tomato and beef||0||0.011||0.001|
|BF, turkey and rice||0||0.035||0.004|
|BF, green beans||0||0.021||0.002|
|BF, mixed vegetables||0||0.02||0.002|
|BF, sweet potatoes||0||0.034||0.013|
|BF, juice, apple||0||0.029||0.006|
|BF, fruit dessert/pudding||0||0.012||0.001|
|Yogurt, lowfat, fruit-flavored||0||0.018||0.002|
|Cheese, Swiss, natural||0||0.016||0.001|
|Bread, multigrain (formerly cracked wheat)||0||0.014||0.002|
|Bagel, plain, toasted||0||0.01||0|
|English muffin, plain, toasted||0||0.024||0.003|
|Peach, canned in light/medium syrup||0||0.038||0.013|
|Pear, canned in light syrup||0||0.03||0.008|
|Pineapple juice, frozen concentrate, reconstituted||0||0.004||0|
|Grape juice, frozen concentrate, reconstituted||0||0.015||0.006|
|Carrot, fresh, peeled, boiled||0||0.019||0.002|
|Tomato juice, bottled||0||0.009||0.001|
|Turnip, fresh/frozen, boiled||0||0.009||0.001|
|Okra, fresh/frozen, boiled||0||0.007||0.001|
|Beef stroganoff with noodles, homemade||0||0.012||0.002|
|Tuna noodle casserole, homemade||0||0.014||0.001|
|Quarter-pound cheeseburger on bun, fast-food||0||0.019||0.002|
|Fish sandwich on bun, fast-food||0||0.021||0.001|
|Egg, cheese, and ham on English muffin, fast-food||0||0.03||0.002|
|Taco/tostada with beef and cheese, from Mexican carry-out||0||0.011||0.001|
|Pizza, cheese and pepperoni, regular crust, from pizza carry-out||0||0.011||0|
|Soup, bean with bacon/pork, canned, condensed, prepared w/ water||0||0.008||0|
|Clam chowder, New England, canned, condensed, prepared with whole milk||0||0.016||0.007|
|Ice cream, regular (not lowfat), vanilla||0||0.009||0|
|Doughnut, cake-type, any flavor, from donut store||0||0.027||0.002|
|Candy, hard, any flavor||0||0.065||0.005|
|Pretzels, hard, salted||0||0.023||0.001|
|Jelly, any flavor||0||0.01||0.001|
|Mustard, yellow, plain||0||0.012||0.003|
|BF, Infant formula, soy-based, RTF||0||0.011||0.001|
|BF, teething biscuits||0||0.033||0.008|
|BF, cereal, rice, dry, prepared with water||0||0.04||0.002|
|Meal replacement, liquid RTD, any flavor||0||0.007||0.001|
|Cottage cheese, creamed, lowfat (2% milk fat)||0||0.009||0|
|Sour cream dip, any flavor||0||0.011||0|
|Beef steak, loin/sirloin, broiled||0||0.018||0.001|
|Luncheon meat (chicken/turkey)||0||0.015||0.001|
|Chicken thigh, oven-roasted (skin removed)||0||0.014||0.001|
|Catfish, pan-cooked with oil||0||0.013||0.001|
|Tuna, canned in water, drained||0||0.019||0.002|
|Pancakes, frozen, heated||0||0.016||0.001|
|Breakfast tart/toaster pastry||0||0.012||0.002|
|Macaroni salad, from grocery/deli||0||0.016||0.002|
|Spaghetti, enriched, boiled||0||0.027||0.001|
|Apricots, canned in heavy/light syrup||0||0.036||0.015|
|Cranberry juice cocktail, canned/bottled||0||0.01||0.001|
|Orange juice, bottled/carton||0||0.006||0|
|Potato salad, mayonnaise-type, from grocery/deli||0||0.01||0|
|Potatoes, mashed, prepared from fresh||0||0.007||0|
|Carrot, baby, raw||0||0.008||0|
|Lettuce, leaf, raw||0||0.014||0.004|
|Sweet potatoes, canned||0||0.018||0.012|
|Tomato salsa, bottled||0||0.009||0.001|
|Stew, beef and vegetable, canned||0||0.009||0|
|Lasagna with meat, frozen, heated||0||0.013||0.001|
|Beef with vegetables in sauce, from Chinese carry-out||0||0.012||0.001|
|Chicken with vegetables in sauce, from Chinese carry-out||0||0.008||0|
|Fried rice, meatless, from Chinese carry- out||0||0||0|
|Burrito with beef, beans and cheese, from Mexican carry-out||0||0||0|
|Chicken filet (broiled) sandwich on bun, fast-food||0||0.012||0|
|Soup, Oriental noodles (ramen noodles), prepared with water||0||0.016||0.001|
|Cake, white with icing (formerly yellow cake)||0||0.009||0.001|
|Granola bar, with raisins||0||0.014||0.001|
|Candy bar, chocolate, nougat, and nuts||0||0.014||0.001|
|Popcorn, microwave, butter-flavored||0||0.028||0.001|
|Sweet & sour sauce||0||0.011||0|
|Salad dressing, creamy/buttermilk type, low-calorie||0||0.018||0.004|
|Salad dressing, Italian, regular||0||0.021||0.002|
|BF, juice, apple-banana||0||0.022||0.005|
|BF, juice, apple-cherry||0||0.023||0.008|
|BF, juice, apple-grape||0||0.019||0.005|
|BF, juice, mixed fruit||0||0.008||0.003|
|BF, juice, pear||0||0.015||0.005|
|BF, juice, grape||0||0.02||0.011|
|BF, pears and pineapple||0||0.009||0.001|
|BF, plums/prunes with apples or pears||0||0.01||0.002|
|BF, apricots with mixed fruit||0||0.007||0|
|BF, banana dessert||0||0.009||0.001|
|BF, peach cobbler/dessert||0||0.012||0.003|
|BF, fruit yogurt dessert||0||0.01||0.002|
|BF, Dutch apple/apple cobbler||0||0.008||0.001|
|BF, arrowroot cookies||0||0.031||0.012|
|BF, zweiback toast||0||0.012||0.002|
|BF, cereal, oatmeal with fruit, prepared with water||0||0.025||0.002|
|BF, chicken with rice||0||0.011||0.002|
|BF, vegetables and turkey||0||0.02||0.004|
|BF, macaroni and cheese||0||0.012||0.001|
|BF, apples with berries||0||0.021||0.001|
|BF, apples with fruit other than berries||0||0.014||0.001|