Just finishes a wonderful Thanksgiving meal, and thought I would post a little research.
FDA Publishes Revised Consumer CBD Update
Submitted by Marijuana News on Thu, 11/28/2019 - 11:12
The U.S. Food and Drug Administration has sent another batch of warning letters to CBD vendors and again expressed concerns about the safety of cannabidiol.
15 companies were recently sent warning letters concerning the alleged illegal sale of CBD products the FDA says violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA also published a revised Consumer Update describing the FDA’s concerns about cannabidiol products in general. The FDA states that based on what it says is a lack of scientific information regarding the safety of cannabidiol in food, it cannot conclude CBD is Generally Recognized As Safe (GRAS).
“.. we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
In the Consumer Update, the FDA restated its view that it is currently illegal to market CBD in the USA by adding it to a food or labeling it as a dietary supplement.
Results from a recent poll indicated 44% of Americans are less likely to use cannabidiol products after discovering the FDA is yet to implement CBD-related consumer protection standards.
In terms of medicines, the FDA has only approved one CBD-based product to date – Epidiolex. During its Epidiolex review, it identified certain safety risks, including the potential for liver injury (primarily because of contaminants).
Among other concerns raised by the Administration include the potential for CBD to affect the metabolism of other drugs and its interaction with depressants such as alcohol. It should be noted that the FDA does not seem to have the same level of concerns when it comes to drugs marketed by major pharma companies. Some of the most common over-the-counter medications can cause harm when taken with alcohol and other medications. Yet no such studies appear to be warranted by the FDA.
In a nutshell, what the FDA is saying is there is still much it doesn’t know about cannabidiol and it is applying the precautionary principle; and probably throwing a scare into some consumers – an intended effect. To what degree this approach is justified remains to be seen – but no-one would argue there aren’t products currently available that shouldn’t be on shelves due to issues relating to quality and labeling.
FDA Publishes Revised Consumer CBD Update
Submitted by Marijuana News on Thu, 11/28/2019 - 11:12
The U.S. Food and Drug Administration has sent another batch of warning letters to CBD vendors and again expressed concerns about the safety of cannabidiol.
15 companies were recently sent warning letters concerning the alleged illegal sale of CBD products the FDA says violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA also published a revised Consumer Update describing the FDA’s concerns about cannabidiol products in general. The FDA states that based on what it says is a lack of scientific information regarding the safety of cannabidiol in food, it cannot conclude CBD is Generally Recognized As Safe (GRAS).
“.. we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
In the Consumer Update, the FDA restated its view that it is currently illegal to market CBD in the USA by adding it to a food or labeling it as a dietary supplement.
Results from a recent poll indicated 44% of Americans are less likely to use cannabidiol products after discovering the FDA is yet to implement CBD-related consumer protection standards.
In terms of medicines, the FDA has only approved one CBD-based product to date – Epidiolex. During its Epidiolex review, it identified certain safety risks, including the potential for liver injury (primarily because of contaminants).
Among other concerns raised by the Administration include the potential for CBD to affect the metabolism of other drugs and its interaction with depressants such as alcohol. It should be noted that the FDA does not seem to have the same level of concerns when it comes to drugs marketed by major pharma companies. Some of the most common over-the-counter medications can cause harm when taken with alcohol and other medications. Yet no such studies appear to be warranted by the FDA.
In a nutshell, what the FDA is saying is there is still much it doesn’t know about cannabidiol and it is applying the precautionary principle; and probably throwing a scare into some consumers – an intended effect. To what degree this approach is justified remains to be seen – but no-one would argue there aren’t products currently available that shouldn’t be on shelves due to issues relating to quality and labeling.
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