Download There is a new Proposition 65 warning label on EFI products sold in

There is a new Proposition 65 warning label on EFI products sold in the State of California.
What is California Proposition 65?
It is a labeling regulation for California consumers. No other state has such a labeling regulation. It is not a national
standard related to health or safety, it is unique to California. 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 Enzyme Formulations products?
Some products may have all or a portion of the following warning on the label or on our 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.
Why did Proposition 65 warning labels suddenly appear on Enzyme Formulations products sold to California?
The products have not changed. EFI products continue to be below USP (United States Pharmacopeia) limits for Heavy
metals. EFI had not previously utilized a Proposition 65 label due to the size of our company. Proposition 65 exempts
companies of less than 10 employees, and until recently EFI employed less than 10 people. Californians passed
Proposition 65 in 1987 and this regulation is generally enforced through legal actions initiated by some California citizens
as opposed to educational programs and advisory notices. Enforcement frequently results in application of a warning
label like the one that has appeared on the bottles of EFI products regarding lead content
Exactly what triggers this warning?
In EFI products, a microscopic amount of lead triggers this warning. The level that triggers this warning is far below the
level associated with actual reproductive harm.
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 divides this
number 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”. Based on these numbers, 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. In contrast, the USP (United States Pharmacopeia) limit for lead is about 15 micrograms per maximum daily usage.
How does the Prop 65 lead level of 0.5 mcg compare to other sources of lead?
Proposition 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*
Air
Water
Food
4.0 mcg/day
5.0 mcg/day
20 – 90 mcg/day
*from World Health Organization estimates
Selected Foods Reported to Contain over 1 mcg Lead
Per Serving (avg. lead content in mcg)**
Chocolate syrup, 4 tablespoons
1.1
Baby food grape juice, 1/2 cup
1.4
Canned sweet potatoes, 1/2 cup
1.5
Baby food sweet potatoes, 1 jar (1/2 cup)
1.7
Spinach, 1/2 cup cooked
2.6
Cabbage, 1/2 cup cooked
3.1
Lettuce, 5 leaves
11.6
Canned tuna, 3 ounces (1/2 can)
23.5
Scallops, 4 ounces
38.1
**from the 2010 US FDA Total Diet Study
There is a new Proposition 65 warning label on EFI products sold in the State of California.
Why does product XYZ not bear this label?
Since the warning is associated with cumulative daily load, a common counter-measure employed is to reduce the
serving size and/or the number of servings in the product’s directions for use. This is why many dietary supplements on
the market have directions for use which read “Take 1 capsule, 1 time daily.” Another common method is to reformulate
the product using extracts or other ingredients. EFI chose not to employ either of these methods. Reducing the serving
and/or serving size would greatly reduce the effectiveness of the product and using an extract in place of a root or leaf
herb would not yield the same benefits. The whole food is superior to an isolated compound from that whole food.
Why is lead found in foods, vitamins, and minerals?
Lead is widespread in nature and in our soil, it is found in many foods and botanical products. Lead is a natural
component of the soil, and measurements of soil lead levels around the world have been made, indicating some natural
variability by location. No lead is intentionally added to the botanical products during manufacture; rather, the lead is
taken up by the plants from what is already in the soil, which is not necessarily any different than soil elsewhere.
Are Enzyme Formulations products safe?
Yes, all of our products are extensively tested for identity, purity and potency.
What level of lead is in EFI products?
The lead level of EFI products will vary somewhat from batch to batch. This is due to several factors:
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The botanical and whole food ingredients we use come from a wide geographic area.
The ingredients are different from product to product.
Plants take up lead at different rates. Factors affecting lead uptake by plants include not only their species and
the amount of lead in the soil, but the acidity of the soil as well.
Lead becomes more concentrated in roots and barks than in the leaves and flowers of most plants.
EFI routinely tests of our raw materials and finished products. Lead levels in EFI products are no different than the levels
found in similar dietary supplements manufactured in the U.S., and the usual range is 0.15 to 1.5 ppm in a finished
product, with an average value around 0.8 ppm. In order to meet Proposition 65 limits, the maximum level would have
to be 0.08 ppm, a level not attainable in a product formulated with multiple botanical ingredients. EFI products meet or
exceed the standards relied upon by all other countries, including the U.S., except for the unusual requirements of
Proposition 65.
How are products tested for heavy metals?
We use Inductively Coupled Plasma/Mass Spectrometry (ICP/MS), a very sensitive analytical method for testing heavy
metals.
What are you doing to protect consumers from heavy metals and other toxic chemicals?
Enzyme Formulations has been formulating and distributing high quality dietary supplements for over 20 years. We
maintain strict oversight of the quality of our products. Our manufacturers have been independently audited and
certified for quality and compliance with the FDA’s regulations for Good Manufacturing Practices (GMPs). We routinely
test raw materials and finished products for contaminants such as heavy metals (lead, arsenic, cadmium and mercury),
pesticides, aflatoxins, and micro-organisms.