California Prop 65 Warning
|Information for California Residents - California Proposition 65|
What is California Proposition 65?
California Proposition 65 is unique. It is a labeling regulation for California consumers and not an FDA or 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 our products?
A few products may have a different suggested dosage for California consumers. A small number of products may have the following warning on the label or an online retailer’s website:
WARNING: This product can expose you to lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov
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.
How is the warning level for lead determined?
The California Office of Environmental Health and Hazard Assessment (OEHHA) sets the warning level for lead 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 set by default at 0.5 micrograms (one-half of a microgram). A microgram is one-millionth of a gram. However, there are certain allowances for “naturally occurring” amounts and different levels are also set in court-ordered agreements.
Why is lead found in foods, vitamins and minerals?
Widespread in nature and in soil, low levels of lead are 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 WellicaNutriton.com products are tested for heavy metals and never exceed the levels set by the USP (United States Pharmacopeia) and International and FDA guidance documents.
Why do I see a warning on a product sold on the internet, but not on the same product sold in my local store?
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 by retail outlets to California will show the warning if necessary. The warning requirements of internet retailers are governed by retailers and the retailers have their own methods of providing the warnings according to the regulations. 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:
*According to World Health Organization estimates
**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?
We have been selling high quality dietary supplements under the Wellica brand since the 1990’s. Wellica on sells USA made products that are researched, quality control, manufacturing and packaging operations which enable us to maintain strict oversight of the quality of the products we sell. Our brands routinely test all raw ingredients and finished products for heavy metals (lead, arsenic, cadmium and mercury). Our manufacturers operations are regularly inspected by the Federal Food and Drug Administration for quality and compliance with the FDA’s regulations for Good Manufacturing Practices (GMPs).
What about certain products that have a Prop 65 cancer warning?
Three ingredients in our products – Progesterone (Topical), L-Dopa (Dietary Supplement) and Goldenseal Root Powder (Dietary Supplement) – are listed under Prop 65 as chemicals that can cause cancer. So, products with any amount of these ingredients require a label warning for California consumers as follows:
WARNING: This product can expose you to [Progesterone] [L-Dopa] [Goldenseal Root Powder] which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov
Are Vitamin & Supplement products safe?
Yes, all of our products are safe when used according to the directions and labeled dosage, and 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.pdf