FDA Q & A in May 2019

A major takeaway from today’s FDA press release for the hemp industry is that proper identification of hemp products is crucial. Language warnings in the following FDA warning letter to Advanced Spine and Pain, LLC (d/b/a Relievus) determine that some products may need new names, some need to be removed from market, like pet products, and websites need to scrub down and lighten up on health claims.

Before the FDA’s Public Hearing on May 31, 2019, let’s sharpen our marketing skills, follow guidelines, and set an example for the Gold Standard.

The Gold Standard is set by good farming practices, including soil tests, and using a local reputable processor and an accredited lab and commissioning full profile labs and surprisingly, even with all this there is room for improvement, when one takes heed of the FDA’s warning:

Dear Dr. Young J. Lee:                                                                               

 This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address http://www.relievuscbdoil.com in February 2019 and has determined that you take orders there for the products “CBD Salve,” “CBD Oil” (in 5 different flavors), and “CBD for Dogs,” which you promote as products containing cannabidiol (CBD). We have also reviewed your website at the internet address www.relievus.com, and your social media websites at www.facebook.com/Relievus/ and https://twitter.com/Relievus; these websites direct consumers to your website, http://www.relievuscbdoil.com, to purchase your products. FDA has determined that your “CBD Salve” and “CBD Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).  FDA has also determined that your “CBD for Dogs” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov. In addition, the Federal Trade Commission (FTC) has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. 45(a) and 52.    

Did you catch the need for change in the Gold Standard after reading the above warning letter?

The room for improvement on the Gold Standard is in labeling with a name that does not imply supplement or medicine. The image below is from a book without a story, much like the way labels are read by consumers and the FDA- At First Glance. This can be adventageous in marketing, but with the FDA barreling down the hemp foxes need to swishy-tail back into the forest and come up with another plan.


Photo courtesy of: Selections from a beautifully illustrated 15th century version of the “Tractatus de Herbis”, a book produced to help apothecaries and physicians from different linguistic backgrounds identify plants they used in their daily medical practice.

Educating consumers of the health benefits is going to be an ongoing project, but CBD Girl Next Door is prepared to offer the latest research – for you!

Read the entire FDA April 2, 2019 Press Release.

We can do this! North Carolina is stellar in rising above.

Have a great day!

Your CBD Watchdog

References

Gold Standard

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634781.htm

https://publicdomainreview.org/collections/tractatus-de-herbis-ca-1440/

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