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  Senator Wyden introduces Cannabinoid Safety and Regulation Act

  September 25, 2024 Today, Senate Finance Committee Chairman Ron Wyden (D-OR) introduced legislation that would create a federal regulatory framework for “cannabinoid products” that contain or are derived from hemp as defined in the 2018 Farm Bill. This bill – titled the Cannabinoid Safety and Regulation Act (CSRA) – would establish a regulatory structure for cannabinoid products that contain cannabinoids found naturally in hemp as well as those considered “semi-synthetic” as defined in the legislation. Artificial or fully synthetic cannabinoids would be prohibited in cannabinoid products under the proposed legislation.   The bill requires the U.S. Food and Drug Administration (FDA) to establish a new Center for Cannabinoid Products to carry out the directives and create the regulatory framework for these products consistent with the provisions of the bill. The extensive provisions of the bill include, among other things, facility registration requirements, a product identification system, sales and distribution restrictions, testing requirements, product standards, and criteria for determining when cannabinoid products qualify adulterated or misbranded.    “AHPA is encouraged by Senator Wyden's long-established and continued attention to the hemp industry and appreciates the introduction of this legislation in light of FDA's ongoing refusal to conduct rulemaking to permit the sale of CBD or THC containing conventional foods or dietary supplements. Over the last several months, we have been in active communication with Senator Wyden's office on the provisions of the bill and will be consulting with our membership regarding its contents. The reasonable federal regulation of hemp derived cannabinoid products is long overdue given the proliferation of inconsistent state laws that currently apply to these products,” said AHPA President Michael McGuffin.   “Specific to dietary supplements, we are very pleased Senator Wyden included language in the CSRA that would give FDA the authority to remove from the market dangerous and illegal drugs that masquerade as dietary supplements, such as tianeptine tablets and liquids, while protecting the existing balance struck by the Dietary Supplement Health and Education Act of 1994. The CSRA's ‘Prohibited Act' provision refines overly broad language that was introduced in Congress earlier this year,” McGuffin concluded.

  • Wednesday, September 25, 2024
  • | Posted by AHPA
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  Herbs in History: Borage & Carrot

  September 25, 2024 Enjoying these herbal history lessons? Don't forget to share with your network using the buttons at the top of every entry!   In an effort to preserve and share the fascinating histories of medicinal plants and herbs that have been used around the world for ages, the AHPA Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is honored to partner with Alain Touwaide, Ph.D., and Emanuela Appetiti of the Institute for the Preservation of Medical Traditions to launch the Herbs in History project in 2022. The second year of the series concludes with a look at the histories of borage and carrot. Preview the entries below and visit Herbs in History online to read more. Borage (Borago officinalis L.) Cheerfulness? If we have to believe literature, borage (Borago officinalis L.) (Boraginaceae) was considered as a euphoric agent in the early centuries of the Greek World. Homer, the blind itinerant poet and the author of the Iliad and possibly also of the Odyssey, allegedly mentioned its property to provoke forgetfulness when taken with wine. Thanks to this property, it has been thought to be the famous nepenthes that the Queen of Egypt offered to poor Greek Helen on her sailing back from Troy to Greece after the long and painful war that opposed the Greeks and the Trojans, to relief her mourning and sufferance. Looking closer to the sources, however, we discover quite a different history. | Read more...   Carrot (Daucus carota L.) Deeper History? Carrot (Daucus carota L.) (Apiaceae [formerly Umbelliferae]) is part of our daily life from childhood and is a daily staple. Until not so long ago, it was believed to have only a relatively recent history (Banga 1957: 59): Contrary to most writers on the same subject, it is concluded that there is no evidence that our type of cultivated carrot (Daucus carota s.sp. sativa) was known to the Romans, or to the Europeans at the time of Charlemagne (± 800 A.D.) or before. | Read more...     About the Project Herbs in History is made possible by funding from the AHPA-ERB Foundation, as part of the nonprofit foundation's mission promote education and research on medicinal, therapeutic, and health-promoting herbs. Tune in monthly for thoughtfully detailed historical accounts of herbs you know and love, and learn more about the origins of medicinal plants that have stood the test of time.

  • Wednesday, September 25, 2024
  • | Posted by AHPA
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  AHPA advocates for sensible regulatory solutions to address ‘bad actors’ as FDA pushes for MPL

  September 23, 2024 The American Herbal Products Association (AHPA) disagrees with U.S. Food & Drug Administration (FDA) Deputy Commissioner Jim Jones's recent statement that there exist “virtually no barriers to entry to the dietary supplement market” – a claim he used to support the agency's continued push for a mandatory product listing (MPL) requirement for dietary supplements.   Jones made these statements as part of his September 10, 2024, testimony before the U.S. House Energy and Commerce Committee's Subcommittee on Health during its hearing entitled “Evaluating FDA Human Foods and Tobacco Programs.” At the hearing, Jones posited that “FDA authorities and resources have not kept up” with the dietary supplement marketplace that has grown exponentially since the 1994 enactment of the Dietary Supplement Health and Education Act (DSHEA). Jones further asserted that “bad actors” selling dangerous and illegal products put consumers at risk.   AHPA has a strong history of supporting amendments to dietary supplement laws when such changes clearly benefit consumers and minimize burdens on the industry. For example, AHPA was a leading advocate for establishing serious adverse event reporting requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. While AHPA agrees that FDA has not “kept up” with the complexities of the modern dietary supplement market in certain respects, proponents of MPL requirements have not clearly articulated the benefits of a premarket product listing requirement. Due to this lack of clear benefits, AHPA has long taken the position that it cannot support – but does not oppose – the concept of an MPL requirement for dietary supplements.   That said, AHPA has opposed specific MPL legislative proposals based on their terms, which commonly would overly burden industry, not provide FDA with any information to which it does not already have access under existing law, and do nothing to disrupt the flow of drug-spiked products masquerading as dietary supplements, which would fall outside the scope of MPL requirements applicable only to products meeting the law's definition of “dietary supplement.”   “We have yet to be convinced that the supposed benefits of MPL would justify the costs to industry and FDA as well as the potential unintended consequences that would result from the establishment of such a system,” said AHPA President Michael McGuffin. “However, AHPA supports the creation of a new, targeted ‘prohibited act' that would give FDA the authority the agency seeks to remove dangerous and illegal products, such as tianeptine tablets and liquids, from the market while protecting the existing balance struck by DSHEA.”   AHPA remains committed to working collaboratively with industry colleagues, regulators, and lawmakers to ensure the safety and integrity of the dietary supplement marketplace. However, AHPA urges FDA to focus on enforcing its current regulatory authorities and addressing the real threats posed by dangerous and illegal drugs. AHPA will continue to advocate for regulatory and legislative solutions that will protect consumer access to legitimate products and empower the agency to protect the public health, including by enforcing against criminals who profit from harming consumers while misappropriating the mantle of the responsible dietary supplement industry.

  • Monday, September 23, 2024
  • | Posted by AHPA
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  AHPA submits comments to UK Food Standards Agency’s call for evidence for ashwagandha

  September 18, 2024   AHPA's submission highlights ashwagandha's Botanical Safety Handbook entry, research, and history of traditional use   Amid growing interest and use of ashwagandha (Withania somnifera) around the world, the American Herbal Products Association (AHPA) has submitted comments to the United Kingdom Food Standards Agency's (FSA) call for evidence for ashwagandha issued this year. FSA – the government agency responsible for protecting public health in relation to food in England, Wales and Northern Ireland – issued the call for evidence to “gather information on ashwagandha food supplements in order to build an evidence package which will be assessed through the FSA's risk analysis process.”   Focusing on FSA's request for “any available information/data on the safety assessment of food supplements containing ashwagandha, including toxicological testing and relevant toxicological data” as specified in the call for evidence, AHPA's submission includes comments on: Botanical safety: In the most recently updated entry for ashwagandha in the online edition of AHPA's Botanical Safety Handbook, 2nd Ed., AHPA classifies ashwagandha as a Class 1 herb (safe for consumption when used appropriately) with Class A interactions (no expected clinically relevant interactions). Hepatotoxicity concerns: AHPA reviewed 14 cases linking ashwagandha to liver toxicity. However, insufficient botanical identification, dosage information, and inconsistent assessment methods across the case reports make it difficult to confirm a causal link. Abortifacient claims: Concerns over ashwagandha as an abortifacient are traced to an incomplete interpretation of historical and ethnobotanical reports. Traditional use of ashwagandha, as well as recent research, do not substantiate these claims. Global usage: Ashwagandha's global market presence has surged, potentially leading to more reported cases of adverse effects, though AHPA suggests these could be idiosyncratic. Scientific research: New studies, including 90-day toxicity assessments, may contradict earlier reports in which toxicity concerns were raised. Further, ashwagandha is one of the most researched botanicals with a long history of use in traditional Ayurvedic medicine as well as in contemporary food supplement products. AHPA remains committed to providing science-based guidance and supporting regulatory frameworks that ensure consumer safety while preserving access to widely used herbs such as ashwagandha. As global interest in this botanical continues to grow, AHPA encourages regulators to consider the full scope of scientific evidence and the herb's long-standing history of safe use. The association looks forward to ongoing collaboration with the FSA and other regulatory bodies to ensure transparent, evidence-based decisions that reflect the best available research on ashwagandha.

  • Wednesday, September 18, 2024
  • | Posted by AHPA