What is California Proposition 65?
California Proposition 65 is unique. It is a labeling regulation for California consumers and not a national standard related to health or safety. No other state has such a labeling regulation. Even if a product is safe, in California, Proposition 65 requires a consumer warning if a product contains one of approximately 900 listed substances. The amount of the particular substance in dietary supplements that triggers the label warning is very low and includes a very large margin of safety.
How does this affect some Source Naturals products?
A few products may have a different suggested dosage for California consumers. A small number of products may have all or a portion of the following warning on the label or an online retailer’s website:
California Residents Proposition 65 WARNING: This product contains substances known to the State of California to cause birth defects or other reproductive harm. This warning is required for exposures that exceed 1/1,000 of the level that will have no observable effect. The US Food and Drug Administration (FDA) has not advised anyone to avoid or stop taking this product.
The first sentence of the above warning is the standard Prop 65 reproductive harm warning. With the California Attorney General’s approval, we added the second and third sentences for more clarity.
Exactly what triggers this warning for these products?
A microscopic amount of lead triggers this warning. Lead exists in our air, soil, water, and food crops. The level that triggers this warning is far below the level associated with actual reproductive harm. Because Prop 65 warning levels are stringently low, it is common to find such warnings posted in California restaurants, hotels, schools, grocery stores, and hospitals. Also, two dietary supplement ingredients - Progesterone and L-Dopa - are Prop 65 listed substances, so products with these ingredients require a label warning for California consumers.
How is the warning level determined?
The California Office of Environmental Health and Hazard Assessment (OEHHA) sets the warning level by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals and then adds a very large margin of safety. This “no observable effect level” defined above is divided by 1,000 to get the margin of safety. This margin of safety requires companies to provide a warning if there may be an exposure that exceeds 1/1000th of the “no observable effect level” (NOEL). Based on its NOEL, the warning level for lead is 0.5 micrograms (one-half of a microgram) per maximum daily usage. A microgram is one-millionth of a gram.
Why is lead found in foods, vitamins and minerals?
Widespread in nature and in soil, lead is found in many foods and botanical products. Small amounts of lead are found in many foods and supplements even though they are not added during the manufacturing process. All Source Naturals products are tested for heavy metals and never exceed the levels set by the USP (United States Pharmacopeia).
Why do I see a warning on a product sold locally in my store, and not on the same product sold on the internet?
Prop 65 is a label regulation that only applies to products intended to be purchased or consumed by California residents. It is not a national standard relating to health or safety of the product. No other state has such a labeling regulation.
Product shipped to retail outlets in California will show the warning if necessary. Web pages of online retailers who reasonably expect to sell the same products to California consumers should include the warning. No warning is required for sales to residents of the other 49 states.
How does the Prop 65 lead level of 0.5 mcg compare to other sources of lead?
Prop 65 requires the warning for products sold in California that contain over 0.5 microgram (mcg) of lead per maximum daily usage. This can be compared to other reported environmental exposures to lead:
Adult daily exposures to lead*
||20 – 90 mcg/day
*According to World Health Organization estimates
Selected Foods Reported to Contain over 1 mcg Lead Per Serving (average lead content in mcg)**
|Wine, red or white, 5 ounce glass
|Chocolate syrup, 4 tablespoons
|Baby food grape juice, 1/2 cup
|Pineapple canned in juice, 1/2 cup
|Canned sweet potatoes, 1/2 cup
|Baby food sweet potatoes, 1/2 cup
|Shrimp, 4 ounces
|Spinach, 1/2 cup cooked
|Cabbage, 1/2 cup cooked
|Lettuce, 5 leaves
|Leeks, 1/2 cup
|Canned tuna, 3 ounces (1/2 can)
|Scallops, 4 ounces
**Sources: US FDA Total Diet Study 2010, Kachenko 2006, Voegborlo 1999, Burger 2005.
What are you doing to protect consumers from heavy metals and other toxic chemicals?
Our entire manufacturing operation has been independently audited and certified for quality and compliance with the FDA’s regulations for Good Manufacturing Practices (GMPs) by NSF International, the premier certification organization in this country. http://www.nsf.org/services/by-industry/dietary-supplements/dietary-supplements-gmp-registration
We have been manufacturing high quality dietary supplements under the Source Naturals brand since the early 1980’s. We have our own research, quality control, manufacturing and packaging operations on site at our facilities in Scotts Valley, California which enable us to maintain strict oversight of the quality of our products. We routinely test all raw ingredients and finished products for heavy metals (lead, arsenic, cadmium and mercury).
Are Source Naturals products safe?
Yes, all of our products are extensively tested for identity, purity and potency. We have one of the most rigorous testing programs in the industry.
How are products tested for heavy metals?
All ingredients used are tested by Inductively Coupled Plasma/Mass Spectometry ( ICP/MS), a very sensitive analytical method for testing heavy metals. We test ingredients upon arrival to our facility and also test the finished product for heavy metals.
What other tests are used to ensure product safety?
Organoleptic and Macroscopic Analysis: Traditional control methods used for assessing the physical qualities of raw materials.
Microbiology Screening: Pathogens (coliform, E. coli, Salmonella spp., Staphylococcus aureus, Vibrio spp. Pseudomonas aeruginosa), total aerobic plate count, yeast and mold count
High Performance Liquid Chromatography (HPLC): A sophisticated test used to determine the purity of a material, as well as show and quantify any impurity peaks.
Inductively Coupled Plasma/Mass Spectometry (ICP/MS): Used to quantify metals. Threshold quantifies the heavy metals arsenic, cadmium, mercury and lead in both raw materials and finished products.
Fourier Transform Infrared Spectroscopy (FTIR): Qualitative analysis of pure compounds. A spectrum is produced that is compared against the spectrum of a reference standard certified by an outside agency.
Ultraviolet Spectrophotometry (UV/Vis): Analysis that allows a characterization and quantification of broad classes of constituents, such as polyphenols in green tea extract.
Burger, J., & Gochfeld, M. (2005). Heavy metals in commercial fish in New Jersey. Environmental Research, 99(3), 403–412.
California Environmental Protection Agency, Office of Environmental Health Hazard Assessment. (2013). California Proposition 65 in Plain Language. Retrieved May 16, 2014 from http://oehha.ca.gov/prop65/background/p65plain.html
Kachenko, A. G., & Singh, B. (2006). Heavy Metals Contamination in Vegetables Grown … in Australia. Water, Air, and Soil Pollution, 169, 101–123.
U.S. Food & Drug Administration. (2010). Total Diet Study Statistics on Element Results, Market Baskets 2006-1 through 2008-4. Retrieved May 16, 2014 from http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184293.htm
Voegborlo, R. B., El-Methnani, A. M., & Abedin, M. Z. (1999). Mercury, cadmium and lead content of canned tuna fish. Food Chemistry, 67(4), 341–345.
World Health Organization (2011). Lead in Drinking-water, Background Document, 1-3. Retrieved May 16, 2014 from http://www.who.int/water_sanitation_health/dwq/chemicals/lead/en/