Learn the elements of 21 CFR 111 / current Good Manufacturing Practice (cGMP) regulations that FDA inspections have been focusing on recently
Webinar recorded Dec. 13, 2016. Member cost: $199. Nonmember cost: $499.
Draft NDI guidance fails to achieve FDA's stated goals and is contrary to intent of the law
In comments submitted to the Food and Drug Administration (FDA), the American Herbal Products Association (AHPA) expressed concern that the latest revision of draft guidance for New Dietary Ingredients (NDIs) is unlikely to achieve FDA's stated goals and is contrary to the intent of the law in numerous areas.
DEA should avoid restricting research on new medical uses, health benefits, or other uses for botanicals
In comments submitted last week to the Drug Enforcement Agency (DEA), the American Herbal Products Association (AHPA) urged the agency to refrain from using its authority to effectively remove a plant from the existing marketplace because naturally occurring constituents become scheduled under the Controlled Substances Act (CSA).
Many personal care products and dietary supplements are produced in compliance with USDA's National Organic Progam
AHPA stressed that non-food products, including personal care products, may be agricultural products that can comply with the United States Department of Agriculture (USDA) National Organic Program (NOP).
HHS Secretary has authority to create exceptions to dietary supplement definition
The American Herbal Products Association (AHPA) recommends the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be lawful dietary ingredient in comments submitted to the Food and Drug Administration (FDA).
Guidance helps companies inform consumers and comply with federal regulations
The American Herbal Products Association (AHPA) has published slack-fill guidance to help the regulated supplement industry inform consumers and comply with all relevant federal requirements.
Ayurvedic Products Committee works to promote responsible commerce of Ayurvedic ingredients and products
The American Herbal Products Association (AHPA) has approved the reappointment of Wynn Werner and P K Davè as co-chairs of the AHPA Ayurvedic Products Committee during the AHPA Board of Trustees meeting at SupplySide West in Las Vegas on Oct. 5.
AHPA President Michael McGuffin presents overview of regulatory landscape for botanical raw materials
AHPA President Michael McGuffin presented an overview of U.S. regulations for botanical raw materials at the 2016 Korea-China Joint International Phytonutrient Symposium organized jointly by the Korean Society of Food Science and Technology (KoSFoST) and the Chinese Nutrition Society and held on October 27 in Seoul, Korea.
IADSA October 2016 Newsflash
IADSA is an association focused on the globalization of food supplement markets and regulatory challenges. This issue of the IADSA Newsflash includes an update on the European Commission (EC) request of the European Food Safety Authority (EFSA) to provide a scientific opinion on the safety of green tea catechins with a proposed deadline of October 2017.
A caution to industry and regulators
This article, "A caution to industry and regulators - 'Incidental DNA fragments' may be misinterpreted using Next Generation Sequencing (NGS)," is authored by Dr. Steven Newmaster, Professor, Botany & Genetics/Genomics at the University of Guelph, Dr. Subramanyam Ragupathy, Senior Scientist, NHP Molecular Diagnostics at the Biodiversity Institute of Ontario, and Dr. Robert Hanner, Chief Technology Officer (CTO) at TRU-ID Ltd. These leading DNA experts detai challenges and pitfalls of DNA analysis used to verify the identity of herbal ingredients.