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  Coconut no longer major food allergen in revised FDA guidance

  January 10, 2025 The U.S. Food and Drug Administration (FDA) has recently published the final version of an allergen guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry" (the final guidance). This guidance, intended to explain the application of labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), follows from the publication of a partially finalized version (the draft guidance) in 2022. The American Herbal Products Association (AHPA) submitted comments to this and prior editions of the guidance.   The final guidance includes a table of tree nuts the agency considers major food allergens subject to labeling requirements under FALCPA. In a major shift that follows repeated requests from AHPA and aligned industry, this table no longer includes a number of plant parts not properly classified as major food allergens, tree nuts, or in one even the product of a botanical tree. Chief among the plant parts removed is the coconut, which had been incorrectly treated as a major food allergen by FDA despite a lack of scientific evidence to support its inclusion.    "AHPA has been seeking this change for over a decade," said AHPA President Michael McGuffin. "The removal of coconut from the set of major food allergens, coupled with other clarifications, brings FDA allergen policy one step closer to alignment with reality."   In accordance with AHPA comments, the table of tree nut allergens now solely reflects plant parts referred to as tree nuts in a Senate report on FALCPA, significantly narrowing the scope of label requirements. Also following AHPA's comments, the guidance treats this table as exhaustive, stating that "[o]nly the tree nuts listed in Table 1 are considered major food allergens..." and are subject to applicable labeling requirements.   In its comments, AHPA also recommended that FDA directly state that all other parts of plants bearing covered tree nuts be excluded from labeling requirements. While FDA partially adopted the framing of this recommendation, the final guidance takes the position that other parts of a plant bearing sources of major food allergens are subject to labeling requirements if the resulting food consists of or contains proteins from a major food allergen. As was the case with the Senate report on FALCPA, the definition of "tree nut" remains out of alignment with applicable botanical definitions.   The FALCPA allergen labeling requirements originally took effect in 2006. AHPA will continue its work with the herbal products community to ensure food allergen policy facilitates consumer access to safe, beneficial herbal foods and dietary supplements.

  • Friday, January 10, 2025
  • | Posted by AHPA
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  AHPA President Michael McGuffin to transition to senior advisory role as search for successor begins

  January 8, 2025 Following a tenure of more than 25 years of dedicated service, American Herbal Products Association (AHPA) President Michael McGuffin will transition into a new role as Senior Advisor following the appointment of his successor. To support this strategic move, AHPA has established an internal executive search committee, comprised of select board members and staff, to oversee the process of identifying the next visionary leader of the association.   McGuffin, who has served as AHPA President since 1999, has led the association through a period of remarkable growth in membership and been a driving force behind AHPA's record of trailblazing advocacy on behalf of its members and the wider herbal product and dietary supplement industries. Under his leadership, AHPA has secured significant legislative victories – including the enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a serious adverse event reporting law for dietary supplements – and has produced invaluable industry resources, such as the Botanical Safety Handbook (2nd edition), Herbs of Commerce (2nd and 3rd editions), and numerous guidance policies and documents.   “It has been an honor to lead both this incredible organization and the fight to ensure our families, friends, and neighbors have access to safe, high-quality herbal products and dietary supplements and that our members have a collective voice and the resources they need to succeed despite an ever-evolving regulatory landscape and marketplace,” said McGuffin. “After a long and fulfilling career at the helm of AHPA, this moment feels like the right time for both the organization and for me personally to embrace a change in leadership. I am committed to supporting the association during this period of transition and look forward to working closely with the next AHPA President, whom I will mentor and with whom I will share my herbal expertise and institutional knowledge as I continue to serve AHPA members in my new advisory role.”   “Michael has been an extraordinary leader and a tireless advocate for our industry,” said Kristina Tucker, Chair of the AHPA Board of Trustees. “His contributions have positioned us for continued, unprecedented success, and we are deeply grateful for his commitment to ensuring a smooth transition. We are confident that, through our internal search efforts and engagement with recruiting firms, we will identify a successor who will advance AHPA's mission and build upon Michael's tremendous legacy.”   The search for AHPA's next president commences with an open invitation to the dietary supplement community to express their interest in the position by contacting the executive search committee at SearchCommittee@ahpa.org for more information, including the job description. In addition to this opening search within the AHPA network, the executive search committee is also engaging recruiting firms to help identify candidates who embody the association's values and possess the expertise to navigate the evolving regulatory and market landscape.

  • Wednesday, January 8, 2025
  • | Posted by AHPA
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  IADSA Newsflash for January 2025

  January 7, 2025 AHPA is an active member of IADSA, an association focused on the globalization of food supplement markets and regulatory challenges. AHPA distributes the IADSA Newsflash This issue covers:   China's National Centre for Food Safety Risk Assessment confirmed the safety of titanium dioxide as a food additive. Japan has proposed new rules for capsule and tablet food supplement products that contain microbial-related ingredients. The European Union will reduce the frequency of compliance controls related to ethylene oxide on Indian botanical supplements being imported into the EU. The European Court of Auditors has called upon the European Commission to address the long-standing lack of authorized health claims for botanicals. The European Food Safety Agency is continuing its safety evaluation of berberine and fennel, among other substances, under Article 8 procedures. EFSA has provided updated guidance on tolerable upper limits for vitamins and minerals. EFSA has confirmed the safety of saccharin and silicon dioxide as food additives. The European General Court has overturned the prohibition against Aloe spp. in the EU's regulation on hydroxyanthracene derivatives (HADs). France has released proposed limits for vitamin and minerals that may produce conflicts with the EU harmonization efforts. The UK Committee on Toxicity (COT) has highlighted potential health risks with consumption of curcumin, particularly at high doses. The UK COT has performed an assessment of raspberry leaf and was not able to establish a health-based guidance level. Romania and Turkey are updating their positive lists for botanicals.   AHPA membership and login required.

  • Tuesday, January 7, 2025
  • | Posted by AHPA
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  FDA final "healthy" rule: key herbal takeaways

  January 2, 2025 In late December, the US Food and Drug Administration (FDA) released its final rule on the labeling of foods with the word “healthy” as an implied nutrient content claim. Several elements of the final rule responded to comments from the American Herbal Products Association (AHPA), as detailed below. FDA declined to exempt dietary supplements from the nutrient content and food group equivalency requirements established for conventional foods. In response to comments from AHPA and others, the agency modified the rule such that coffees and teas (of Camellia sinensis specifically) may bear “healthy” nutrient content claims, so long as they do not contain added caffeine and contain fewer than 5 calories per labeled serving and reference amount customarily consumed. In response to comments from AHPA, the agency clarified that the term “healthy” may continue to be used in valid structure function claims. Similarly, products lawfully bearing “healthy” claims in compliance with the prior rule will not be in violation so long as they were labeled in advance of the compliance date. FDA stated that herbs or spices may qualify as vegetables for the purpose of calculating food group equivalence for the use of “healthy” claims, but declined to permit them to automatically qualify as “healthy.” In response to comments from AHPA and others, the agency agreed that dried or other powdered fruits and vegetables can be considered in food group equivalency calculations provided that the powders are essentially the dried and ground forms of the original whole food. The compliance date for the final rule is February 25, 2028. Additional summarizing information on the rule is available at this site.  FDA communicated in the final rule that it intends to, prior to compliance date, provide further guidance to help manufacturers in the calculation of food group equivalence values. AHPA will continue to inform its members and the herbal products community of additional resources on this rule as they become available. 

  • Thursday, January 2, 2025
  • | Posted by AHPA