Brand Owners or Manufacturers—Who’s on the Hook for Compliance?

There are many ways to demonstrate compliance with the Code of Federal Regulations, Prop 65 and other regulatory requirements. However, heavy metal testing is one of the most important and can identify elements that could adulterate the finished product. This testing helps ensure that ingredients used in manufacturing will not contribute to harmful levels of arsenic, cadmium, mercury, lead or other elements. And, it’s not just manufacturers that are on the hook for heavy metal compliance. Even brand owners are responsible for the quality of their finished product and preventing adulteration.  A recent FDA Warning letter highlights the full scope of compliance responsibility:

FDA warning letter to a health food store dated March 9, 2018

  • Although a firm may contract out certain dietary supplement manufacturing, packaging, and labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.

Heavy metals are tested by measuring in low, parts per million levels using sensitive equipment to detect the trace amounts of harmful elements. Ion Coupled Plasma with Mass Spectrometry (ICP-MS) is used most often for this testing. This type of contamination can often be found when plants are grown in soil that contains high levels of these metals. The plants are fed by the soil and may absorb the unwanted elements.  Therefore, all botanical ingredients should be screened to ensure they are free from heavy metal contaminates.

Ingredients that are processed in countries or areas where water quality is a concern will also need to be tested, as tainted water may also lead to heavy metal contamination.  Qualifying each ingredient supplier and testing raw materials is a key component for avoiding adulteration of the finished product.  Although heavy metals are not the only source of adulteration in ingredients, they should be addressed, with specifications set for high-quality finished product. Let SORA Labs help with your heavy metal testing.  Request a quote today!

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