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.”

prop65news.com

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:

  1. “The lowest reported lethal dose in man (LDL0) is 1470 µg/kg”. (INCHEM.org)
  2. “…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)
  3. “TEL [tetraethyl lead] and TML [tetramethyl lead] did not induce mutation in bacteria (IARC, 1987)”. (INCHEM.org)
  4. “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

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.

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.

USANA’s Nutrimeal, MySmart, and Nutritional product lines have the Prop 65 Warning applied to them in California.

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.

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.

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.

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.

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
Cornbread, homemade 0 0.018 0.001
Biscuits, refrigerated-type, baked 0 0.014 0.001
Bread, whole wheat 0 0.011 0.001
Bread, rye 0 0.012 0
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
Peach, raw/frozen 0 0.007 0
Applesauce, bottled 0 0.011 0.001
Pear, raw (with peel) 0 0.009 0.001
Strawberries, raw/frozen 0 0.015 0.002
Fruit cocktail, canned in light syrup 0 0.025 0.011
Grapes (red/green), raw 0 0.019 0.001
Cantaloupe, raw/frozen 0 0.01 0
Grapefruit, raw 0 0.021 0.001
Pineapple, canned in juice 0 0.046 0.009
Raisins 0 0.023 0.005
Avocado, raw 0 0.03 0.001
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
Celery, raw 0 0.005 0
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
Beets, canned 0 0.016 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
Honey 0 0.018 0.004
Tomato catsup 0 0.038 0.003
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
Beer 0 0.006 0
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, carrots 0 0.018 0.005
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, peas 0 0.007 0
BF, applesauce 0 0.009 0.001
BF, peaches 0 0.008 0
BF, pears 0 0.008 0
BF, juice, apple 0 0.029 0.006
BF, custard/pudding 0 0.01 0.001
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
Cream cheese 0 0.033 0.001
Shrimp, boiled 0 0.18 0.012
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
Crackers, graham 0 0.02 0.004
Crackers, butter-type 0 0.019 0.001
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
Mushrooms, raw 0 0.008 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
Brownie 0 0.032 0.01
Sugar cookies 0 0.011 0.001
Candy, hard, any flavor 0 0.065 0.005
Pretzels, hard, salted 0 0.023 0.001
Syrup, chocolate 0 0.027 0.016
Jelly, any flavor 0 0.01 0.001
Mustard, yellow, plain 0 0.012 0.003
Black olives 0 0.014 0.003
Sour cream 0 0.034 0.001
BF, Infant formula, soy-based, RTF 0 0.011 0.001
BF, teething biscuits 0 0.033 0.008
BF, squash 0 0.022 0.002
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
canned/bottled 0 0.014 0.003
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
Olive oil 0 0.02 0.001
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

Source: http://www.fda.gov/downloads/food…totaldietstudy/ucm184301.pdf

 

 

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