The very anticipated hearing has finally come to a set date. On May 31st, the FDA will hold their public hearing to talk more on the matters of Hemp regulation. They told the public they would be publishing more information as the week’s progress. The meeting heard testimony from not only stakeholders but other commissioners who aim to inform the FDA on a sound regulatory approach moving forward. Commissioner Scott Gottlieb continued to echo the words, that regulating CBD into food supply products is extremely complicated and should not be taken lightly. CBD is already found in the form of a prescription medication called Epidiolex, as a side compound and not a single form isolate. This makes the lines even blurrier from the view of the FDA.
A number of unanswered questions were brought up at the hearing, including the safety concerns that the FDA should consider as far as product packaging, formatting, and maximum acceptable daily intakes. No clear solutions were decided on just yet, as these are only preliminary meetings. The FDA seemed confident that they would find these answers through proper clinical investigation, and that companies who are selling this recreationally would not have the incentive to do these trials. Outside of public safety issues they also discussed safe manufacturing practices for CBD. The tone seemed optimistic at best, however, they will be having further meetings and will be hearing from stakeholders on their experiences using the substance. Gottlieb also stated that his goal was to find a way for CBD to be used as a dietary supplement or in conventional foods, while still being lawfully marketed.
We’ll be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
Overall there are alternatives paths they can use to come to a fair rule-making process, and this hearing was one of them. “The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products.” – However, the FDA has not been going easy on companies in the meanwhile. Just this past Tuesday the FDA filed 3 major warnings to the following companies: “PotNetwork Holdings” in Florida, “Nutra Pure” in Washington state and “Advanced Spine and Pain” in New Jersey. The warnings were in a response to more than a dozen different products and advertisements they had involving unsanctioned claims around CBD.
This was part of a crackdown they are taking on what they call “irresponsible marketing.” CVS and Walgreens both recently announced they will begin selling CBD-infused products, and the FDA also made a public statement letting them know they won’t get off too easy. These companies will be watched under scrutiny to make sure they are not using similar, irresponsible marketing tactics.
At the present time, people who are interested in shaping the FDA’s CBD regulatory process can submit public comments until July 2. The FDA says it will soon make information on how to register for the next public hearing available online. Stay tuned for further updates on this developing story.
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