Why is there a warning label on my product?

You are reading this because you are concerned about the following warning that appears on your Haylie Pomroy Group dietary supplement:

This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

Don’t be alarmed. This is a common warning found throughout California on a vast number of products. We have added this warning for all our products per the California Proposition 65 requirements for simplicity, even though the state of California is the only state that requires such labeling. Let’s take a look at the reasons behind this warning and why Proposition 65 may not be producing its intended effect.

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, is a unique California law that was enacted by a voter ballot initiative, not the California Legislature. It requires companies to provide warnings about the presence of any one of over 800 chemicals, including chemicals that are found throughout our environment. Furthermore, Proposition 65 may require a warning even if the amount of the chemical is so small that the product meets federal health and safety guidelines. Although well-intentioned, Proposition 65 has brought about unforeseen consequences. For instance, it requires a warning on products that are made with natural and healthy ingredients because they contain miniscule amounts of certain elements absorbed from the environment.

Why is there a Proposition 65 warning on my dietary supplement?

Some of the more than 800 Proposition 65 chemicals are prevalent in the natural environment. Plants, for instance, absorb minerals from the soil, so these substances unavoidably end up in supplements made with natural, botanical ingredients. Inevitably, it then becomes impossible to produce many supplement formulas with natural, botanical ingredients without having some level of one of the over 800 chemicals present in the finished product.

Let’s use lead as an example:

Lead is an element that occurs naturally throughout the environment. It is everywhere—in the air, in soil, in plants, in lakes, in the ocean, and in the foods we eat. Proposition 65 requires a warning on products that expose consumers to just 0.5 micrograms per day. This is an extremely small amount. A microgram (abbreviated as mcg or μg) is one millionth of a gram. Imagine cutting a sugar cube (which weighs about one gram) into one thousand pieces and then cutting one of those tiny pieces into another thousand pieces. That’s a microgram. As an example, a 4 ounce (1/2 cup) serving of raw spinach can have a mean average of 0.45 mcg of lead that is naturally occurring.

Should I be concerned about my dietary supplement?

According to the California Office of Environmental Health Hazard Assessment, which is the governmental agency that administers Proposition 65, “a Proposition 65 warning does not necessarily mean a product is in violation of any product-safety standards or requirements.” Are your dietary supplements likely to put you at risk? No. That said, you must always consider your total exposure from all sources.

The Food and Drug Administration (FDA) created the extremely cautious provisional total tolerable intake level for lead for certain people and age groups. For instance, a child under 6 years of age can have 6 mc g/d and an adult 75 mcg/d. You can see that even these more stringent federal “safe” levels are much higher than what might be found in a dietary supplement or in common foods such as organically grown spinach.

By comparison, for our supplements made with ingredients that contain lead pulled from the environment, we are providing Proposition 65 warnings whenever recommended dosages would result in you consuming a fraction of the lead present in those common food products: .5 mcg per day. In other words, a warning is being given even though you would get less lead from the dietary supplement than from eating a dill pickle.

Why does a dietary supplement have a Proposition 65 warning in California, while the same exact formula with the same ingredient levels sold or distributed in any other state does not?

Simple: Because California voters decided to require warnings even if the chemical comes from natural ingredients and even if it is present at minute levels.

What levels of heavy metals are found in Haylie Pomroy Group formulas?

We test all of our formulas for lead, cadmium, arsenic, and mercury, and they comfortably meet the more realistic limits set forth by the United States Pharmacopeia (USP). USP limits are as follows:

Lead: no more than 10 mcg/day

Cadmium: no more than 5 mcg/day

Arsenic (inorganic): no more than 15 mcg/day

Mercury (total): no more than 15 mcg/day

Methylmercury (as Hg): no more than 2 mcg/day

 

How can I be assured that my Haylie Pomroy Group supplements are as pure as possible?

The testing of Haylie Pomroy Group formulas for heavy metals is a regular part of our Current Good Manufacturing Practice (cGMP) and quality assurance procedures. In addition to testing for heavy metals, all of Haylie Pomroy Group dietary supplements are tested for:

  • The presence of microorganisms. Every formula must meet USP specifications to be released.
  • Finished product potencies. Each ingredient must meet label claim displayed on the supplement facts box.
  • Reasonably anticipated contaminants.

Furthermore, to assure that the raw material a vendor supplies is what they say it is, each and every lot received is quarantined and verified before being released for use in a formula.

Important takeaways:

  • Haylie Pomroy Group formulas follow strict guidelines for purity—from acquisition of raw materials to production of finished formula.
  • Haylie Pomroy Group formulas meet the purity criteria of federal organizations.
  • No such warning is needed or required on any Haylie Pormoy Group formula sold internationally or in states other than California.
  • Proposition 65’s criteria require companies that use natural ingredients containing low levels of lead from the environment to put warnings on the formulas they sell and distribute in California.
  • While Proposition 65 was well-intentioned and has made consumers safer in many cases, we believe that it has also evolved into a litigious and perplexing law that confuses consumers and often does nothing to advance public health.

 

If you need additional information, please contact Haylie Pomroy Group Technical Support. We value informing our clients and assuring your best health.

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