Guidance on allergens in Traditional Chinese Medicine (TCM)

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    Guidance on allergens in Traditional Chinese Medicine (TCM)

    Free guidance for AHPA members

    Published: Monday, July 12, 2021

    AHPA has published a revised version of the guidance document titled “Compliance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) for Marketers of Chinese Herbal Products” to include the requirements of the recently adopted Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), which adds sesame to the list of major food allergens that require labeling in the United States. The new requirements in the FASTER Act amend the definition of “major food allergen” in FALCPA and take effect on January 1, 2023.

    AHPA first published this guidance in November 2019, to provide members with a summary of FALCPA and to identify ingredients and preparations found in traditional Chinese herbal ingredients and formulas that may require labeling as major food allergens.

    FALCPA established specific labeling requirements for foods, including dietary supplements, that contain food ingredients identified under this law to be “major food allergens.” The primary labeling requirements for food ingredients covered by FALCPA is simply that these be disclosed on the label of a food product that contains any major food allergen. While this may seem straightforward, failure to properly identify allergens on food labels has become one of the most common reasons for food recalls over the past several years.

    A number of AHPA’s members market products that consist of or contain ingredients used in Chinese herbal traditions such as Traditional Chinese Medicine (TCM), and some of these ingredients require labeling as allergens. Members therefore should understand the requirements of this law when using these ingredients.

    This guidance document addresses the following topics:

    • Major food allergens
    • Tree nuts requiring allergen labels
    • Exemptions to FALCPA labelling
    • Traditional Chinese ingredients and formulas that may contain allergens
    • FDA resources for allergen labeling

    Information collected by AHPA from experts with extensive experience in the composition and processing of ingredients and formulas used in Chinese herbal traditions was used to identify ingredients and formulas that are composed of a major food allergen or that may contain major food allergens due to the method of preparation or processing of an ingredient.

    AHPA acknowledges the contributions of many members of the AHPA Chinese Herbal Products Committee in developing and maintaining this guidance and welcomes additional suggestions so the guidance can be revised as additional insights are gained through its practical use.

    Download the Guidance here.


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