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FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements

Various Dietary Supplements 2019

FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.

Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”

Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.

“While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk,” he said. “As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.”

FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.

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