AER Compliance Will Require Preparation, Preparation, Preparation – AHPA
This article was originally published in The Tan Sheet
Executive SummarySome dietary supplement firms plan to hire contractors to handle consumers' adverse event reports, but most firms will not need outside help if they properly prepare for collecting AERs, industry experts said during a training seminar Feb. 22
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“We ought to deal with this. There are questions on long-term safety and questions on efficacy claims that are just not proven,” says the Maryland Republican. “The biggest threat hanging over, in my mind, the farmers who want to grow hemp, is what if the FDA comes out tomorrow and says, ‘You can't sell any product’? The market collapses,”he said at a CBD policy conference.
Minnesota Democrat Collin Peterson’s bill, the first targeting FDA’s CBD question, could provide an entire answer or it could set table for discussion in Congress about legislation on establishing an FDA regulation on using CBD, and potentially other hemp-derived substances, in products other than drugs subject to its oversight.