{"id":2202,"date":"2021-08-24T19:13:22","date_gmt":"2021-08-24T19:13:22","guid":{"rendered":"https:\/\/mysafesmoke.com\/the-fda-defers-to-pharma-nixes-cbd-as-dietary-supplement\/"},"modified":"2021-08-24T19:13:22","modified_gmt":"2021-08-24T19:13:22","slug":"the-fda-defers-to-pharma-nixes-cbd-as-dietary-supplement","status":"publish","type":"post","link":"https:\/\/mysafesmoke.com\/the-fda-defers-to-pharma-nixes-cbd-as-dietary-supplement\/","title":{"rendered":"The FDA Defers to Pharma, Nixes CBD as Dietary Supplement"},"content":{"rendered":"


\n<\/p>\n

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On Aug 12, the FDA<\/span> formally rejected two New Dietary Ingredient (NDI<\/span>) applications seeking to establish CBD<\/span> as a lawful dietary supplement. Apparently, the fix was in from the start. The FDA<\/span> never intended to approve the applications by Charlotte\u2019s Web, a pioneer CBD<\/span> brand, and Irwin Naturals, a legacy supplement company that has jumped into the CBD<\/span> space.<\/p>\n

Although millions of doses of CBD<\/span> have been consumed in the United States, the FDA<\/span> claims it has insufficient data to assess if there\u2019s a dosage of CBD<\/span> that\u2019s safe for consumers. Irrespective of real or imagined safety concerns, it seems that the FDA<\/span> was committed to delivering a predetermined thumbs-down verdict in keeping with the \u201cexclusionary clause\u201d of the 1994 Food Drug and Cosmetic Act, whereby supplements can\u2019t contain pharmaceutical ingredients.<\/p>\n

Although millions of doses of CBD<\/span> have been consumed in the United States, the FDA<\/span> says it has insufficient data to assess if there\u2019s a dosage of CBD<\/span> that\u2019s safe for consumers.<\/p>\n

In effect, the FDA<\/span> equated the CBD<\/span> in the unregulated market (isolates as well as full-spectrum hemp extracts) with the cannabidiol in Epidiolex, the FDA<\/span>-approved pharmaceutical CBD<\/span> (mixed with ethanol and sucralose, the artificial sweetener) that\u2019s used to treat pediatric epilepsy. Ironically, invoking the exclusionary clause implies recognition on the FDA<\/span>\u2019s part that the CBD<\/span> sold as supplements could also be therapeutically beneficial \u2013 given that the same ingredient is found in pharmaceutical CBD<\/span>.<\/p>\n

Out of deference to Pharma, the FDA<\/span> has refused to provide a regulatory framework for CBD<\/span> supplements, which technically are not legal but remain on the shelves because of a lack of federal enforcement. So now it will be up to Congress to clarify CBD<\/span>\u2019s status and craft a better policy for producers and consumers.<\/p>\n

<\/div>\n

Debunking claims of liver toxicity<\/h2>\n

Recent rulings by the FDA<\/span> rejecting NDI<\/span> submissions from CBD<\/span> brands cite concerns about a lack of safety data addressing liver toxicity. Fortunately, there\u2019s a large scale clinical study underway to assess the safety and efficacy of the daily use of CBD<\/span> supplements particularly with respect to liver health.<\/p>\n

Conducted by the Denver-based medical research firm ValidCare, the National CBD<\/span> Safety study has already completed trials involving more than 1000 volunteers. Thus far, the preliminary results are very positive. Contrary to FDA<\/span> warnings, the ValidCare findings show \u201cno clinical evidence of liver disease in any of the participants.\u201d<\/p>\n

Project CBD<\/span> has helped recruit subjects for the ValidCare study. To increase the confidence level of the data for liver safety, Project CBD<\/span> is once again seeking volunteers who are regular users of CBD<\/span> products to participate in ValidCare\u2019s 30-day clinical observational trial. This will help to advance our understanding of the science and safety of CBD<\/span>.<\/p>\n

The FDA<\/span>\u2019s latest rejection of CBD<\/span> as a dietary supplement underscores the importance of this research effort. Seventeen CBD<\/span> brands are supporting ValidCare\u2019s liver study, and we hope you will, as well, by volunteering to participate as test subjects. The final results will be disclosed by the end of the year. Peer-reviewed safety data will be provided to members of Congress as they consider whether to override the FDA<\/span>\u2019s obstructionist CBD<\/span> policy.<\/p>\n

\"\"\/<\/div>\n

Volunteers needed<\/h2>\n

All participants in the ValidCare study will receive free study product for the trial \u2013 either tinctures or soft gels. Those who complete the entire month-long study and provide a blood sample will also receive a $100 gift card. To learn more about volunteering and to submit a formal application to participate, contact ValidCare, the medical research company that is conducting this study. You will be required to use an app for 30 days to document your use of a hemp-derived CBD<\/span> product, how it affects you, if you experience any side effects, and any other relevant feedback. After 30 days, you will be expected to provide a blood sample for liver test functioning at a nearby Quest diagnostic lab.\u00a0(Please note that labs in NY<\/span>, NJ<\/span>, and RI<\/span> have different regulations on drawing blood samples, so residents of these states will need to go to CT<\/span>, MA<\/span>, or PA<\/span> to draw blood for a liver test.)<\/p>\n

To recap, all volunteers who complete the 30-day trial will receive:<\/p>\n

A free supply of CBD<\/span> tincture or gel caps for the duration of the study, and possibly longer
\nVisa gift card ($100)
\nAn opportunity to advance our knowledge of the safety and efficacy of CBD<\/span>.<\/p>\n

For more information about this important study, contact ValidCare.\u00a0<\/p>\n

Thanks from Project CBD<\/span>!<\/p>\n

APPLY<\/span> HERE<\/span><\/p>\n

Copyright, Project CBD<\/span>. May not be reprinted without permission.<\/p>\n<\/div>\n


\n
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On Aug 12, the FDA formally rejected two New Dietary Ingredient (NDI) applications seeking to establish CBD as a lawful dietary supplement. Apparently, the fix was in from the start. 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