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Published: Wednesday, April 25, 2018
AHPA President Michael McGuffin stressed that any company looking to sell kratom or kratom products must comply with all applicable laws and regulations during a press conference.
"As with all trade associations, the American Herbal Products Association, or AHPA, serves a unique role in the interface between regulatory agencies and the relevant regulated trade. We do this both by providing guidance and encouraging best practices for industry and by communicating with regulators on behalf of the trade. When it comes to the particular case of kratom, AHPA views this as just one of the many herbs or other botanicals that are allowed under U.S. law to be marketed as a dietary supplement so long as products containing kratom comply with all applicable regulations. On the specific issue of salmonella under discussion today - AHPA strongly recommends that we all recognize that FDA's public health mission comes first - so any company that is informed by FDA that a voluntary recall is in order due to the agency's finding salmonella in a product needs to recognize this as a reflection of that priority public health mission. More generally, AHPA also notes that the Food and Drug Administration has identified kratom as a 'new dietary ingredient' (or NDI) and so AHPA has recommended that companies that want to market kratom comply with FDA's new dietary ingredient requirements by submitting an NDI notification in conformity with FDA's rules. At the same time, we encourage FDA to treat any such kratom NDI notification exactly as it would a notification for any other new herb. AHPA has also circulated suggestions that kratom marketers understand and meet all of the other regulations required for any herbal product sold as a dietary supplement, such as registering as a food facility, meeting the extensive good manufacturing practice rules, refraining from making any drug claims, and submitting to FDA all serious adverse event reports received in association with their kratom products."
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