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“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or

“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

chime 8y ago
I've tried reading this release and this page https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.h... but still can't figure out if CBD oil is legal or illegal. Are CBD gummies suddenly illegal? Or are they suddenly 100% legal (and no longer in the gray area)?
- deleted 8y ago
  [deleted]
- Alex3917 8y ago
  Products advertised to contain CBD are schedule 1 unless the FDA grants them marketing approval, in which case they're schedule 5. Products that incidentally contain CBD but aren't advertised as containing it may be more of a grey area, but IANAL. But yeah this is terribly written, they should really hire the SEC to write their press releases for them.
  - HillaryBriss 8y ago
    Yeah, I have to agree. I read it the same way you have. Especially ...both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply ... I may be totally wrong here, but I feel like the FDA, rather than easing up on the regulation of marijuana, has just stated that it's about to clamp down on all these products currently being marketed at your local medicinal pot store.
    - jjeaff 8y ago
      Actually, I think you just have to read this in its beurocratic context. The new law has removed hemp from the schedule 1 list. So it is no longer completely illegal. But at the same time, this press release from the FDA is trying to make sure everyone knows that the FDA still maintains their jurisdiction over it within their umbrella of power. And the FDA has power over any medicine or product that makes a therapeutic claim AND all food products. The thing they don't mention (and this is the most important part) is that hemp products can now be sold legally. Because they are no longer a controlled substance. BUT you can't advertise them as being for human consumption or having therapeutic value. This is why you can't buy antibiotics without an RX. It falls under FDA authority. But you can buy those same antibiotics for fish, without a license. Because some types of animal products don't fall under their authority. So I'm betting you will be able to buy CBD oil "not for human consumption" to fix squeeky wheels or as an air freshener or whatever. But the FDA will have to go through their normal review process before a product can be sold in food or in a supplement. As for all the products already out there, I have no idea. Because my understanding of FDA regulations is that they were already in violation since they were being sold as dietary supplements or something with therapeutic benefit.
- pmoriarty 8y ago
  Are CBD gummies a food or a medicine? They might be treated differently depending on how they're classified. Something else to consider is that there are plenty of products that don't have to prove their safety -- products which the FDA blesses as "GRAS" ("Generally Recognized As Safe"), though it's unlikely that CBD will fall under this classification either. Both alcohol and some medicines (like quinine[1], which is added to tonic water) the FDA apparently has no problems with, despite some of these ingredients (like alcohol) being very far from safe, much less proven to be safe in "substantial clinical investigations". [1] - https://en.wikipedia.org/wiki/Quinine https://en.wikipedia.org/wiki/Quinine
  - burfog 8y ago
    Alcohol is special. We didn't merely undo prohibition. With that constitutional amendment, we removed most federal authority over alcohol. The commerce clause does not apply anymore (State Board of Equalization v. Young's Market Co.), and thus can't be abused to regulate alcohol. About the only thing the federal government can do about alcohol is arm-twist the states into regulating it via things like highway funding being conditional on the existence of state regulations.
    - Aloha 8y ago
      Thats not exactly accurate - the feds do have various rules about booze, including what constitutes bourbon, for example.
    - torstenvl 8y ago
      > With that constitutional amendment, we entirely removed federal authority over alcohol. Where are you getting that from?
      - burfog 8y ago
        OK, mostly Section 2 of the 21st amendment was ruled on in State Board of Equalization v. Young's Market Co. and shown to give states unusual control of alcohol.
Simulacra 8y ago
This has to do with section DSHEA and section 343, particularly as it has to do with New Dietary Ingredients. In a nut shell, DSHEA said that anything produced after 1993 but has been used as, or in, a dietary supplement prior to 1993 for it to be legal. If it's not, then it is considered a New Dietary Ingredient (NDI) and thus must submit an NDI notification to the FDA. This is to notify that the ingredient was not present as, or in, a dietary supplement prior to 1993. It's super tedious because it's been 25 years since DSHEA and the FDA has yet to produce a final guidance or rule on dietary NDI submissions.
corey_moncure 8y ago
Where "interstate commerce" := all commerce.

chime 8y ago

I've tried reading this release and this page https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.h... but still can't figure out if CBD oil is legal or illegal. Are CBD gummies suddenly illegal? Or are they suddenly 100% legal (and no longer in the gray area)?

deleted 8y ago
[deleted]
Alex3917 8y ago
Products advertised to contain CBD are schedule 1 unless the FDA grants them marketing approval, in which case they're schedule 5. Products that incidentally contain CBD but aren't advertised as containing it may be more of a grey area, but IANAL. But yeah this is terribly written, they should really hire the SEC to write their press releases for them.
- HillaryBriss 8y ago
  Yeah, I have to agree. I read it the same way you have. Especially ...both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply ... I may be totally wrong here, but I feel like the FDA, rather than easing up on the regulation of marijuana, has just stated that it's about to clamp down on all these products currently being marketed at your local medicinal pot store.
  - jjeaff 8y ago
    Actually, I think you just have to read this in its beurocratic context. The new law has removed hemp from the schedule 1 list. So it is no longer completely illegal. But at the same time, this press release from the FDA is trying to make sure everyone knows that the FDA still maintains their jurisdiction over it within their umbrella of power. And the FDA has power over any medicine or product that makes a therapeutic claim AND all food products. The thing they don't mention (and this is the most important part) is that hemp products can now be sold legally. Because they are no longer a controlled substance. BUT you can't advertise them as being for human consumption or having therapeutic value. This is why you can't buy antibiotics without an RX. It falls under FDA authority. But you can buy those same antibiotics for fish, without a license. Because some types of animal products don't fall under their authority. So I'm betting you will be able to buy CBD oil "not for human consumption" to fix squeeky wheels or as an air freshener or whatever. But the FDA will have to go through their normal review process before a product can be sold in food or in a supplement. As for all the products already out there, I have no idea. Because my understanding of FDA regulations is that they were already in violation since they were being sold as dietary supplements or something with therapeutic benefit.
pmoriarty 8y ago
Are CBD gummies a food or a medicine? They might be treated differently depending on how they're classified. Something else to consider is that there are plenty of products that don't have to prove their safety -- products which the FDA blesses as "GRAS" ("Generally Recognized As Safe"), though it's unlikely that CBD will fall under this classification either. Both alcohol and some medicines (like quinine[1], which is added to tonic water) the FDA apparently has no problems with, despite some of these ingredients (like alcohol) being very far from safe, much less proven to be safe in "substantial clinical investigations". [1] - https://en.wikipedia.org/wiki/Quinine https://en.wikipedia.org/wiki/Quinine
- burfog 8y ago
  Alcohol is special. We didn't merely undo prohibition. With that constitutional amendment, we removed most federal authority over alcohol. The commerce clause does not apply anymore (State Board of Equalization v. Young's Market Co.), and thus can't be abused to regulate alcohol. About the only thing the federal government can do about alcohol is arm-twist the states into regulating it via things like highway funding being conditional on the existence of state regulations.
  - Aloha 8y ago
    Thats not exactly accurate - the feds do have various rules about booze, including what constitutes bourbon, for example.
  - torstenvl 8y ago
    > With that constitutional amendment, we entirely removed federal authority over alcohol. Where are you getting that from?
    - burfog 8y ago
      OK, mostly Section 2 of the 21st amendment was ruled on in State Board of Equalization v. Young's Market Co. and shown to give states unusual control of alcohol.

Simulacra 8y ago

This has to do with section DSHEA and section 343, particularly as it has to do with New Dietary Ingredients. In a nut shell, DSHEA said that anything produced after 1993 but has been used as, or in, a dietary supplement prior to 1993 for it to be legal. If it's not, then it is considered a New Dietary Ingredient (NDI) and thus must submit an NDI notification to the FDA. This is to notify that the ingredient was not present as, or in, a dietary supplement prior to 1993. It's super tedious because it's been 25 years since DSHEA and the FDA has yet to produce a final guidance or rule on dietary NDI submissions.

corey_moncure 8y ago

Where "interstate commerce" := all commerce.