FDA open to possibility of legalizing some cannabis products
Posted May 8, 2019
In the coming months, the Food and Drug Administration will weigh whether certain food and dietary supplements containing cannabis or cannabis derivatives can be sold without violating federal law. Cannabis's potential to compromise food safety or harm animals is just one of the many issues the agency will consider.
In April, the FDA laid out its plan to study the issue, which was prompted by growing interest in FDA-regulated products derived from Cannabis sativa L. and its components, including CBD.
"We've seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things," said Scott Gottlieb, MD, then FDA commissioner, in a press release.
"We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products," added Dr. Gottlieb, who stepped down April 5.
The FDA plan features a public hearing set for May 31 to gather stakeholder input. The agency will convene an internal working group to study the issue, taking into account statutory or regulatory changes necessary to legally market the products. The working group will also look at potential public health impacts resulting from the availability of such products.
In addition, the FDA is updating its webpage to answer frequently asked questions and help the public understand how the agency's requirements apply to these cannabis and cannabis-based products. Moreover, the agency has issued several warning letters to companies marketing CBD products with unfounded claims of therapeutic benefits.
Although the 2018 Farm Bill removed hemp from the Controlled Substances Act, "Congress explicitly preserved the FDA's current authority to regulate products containing cannabis or cannabis-derived compounds," Dr. Gottlieb said.
"The only path that the (Federal Food, Drug, and Cosmetic) Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use."
As part of the public hearing and related public comment period, the FDA is interested in data and information about the safety of cannabis and cannabis-derived compounds. For instance, the FDA asks, "Are there special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class) that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds?"
Also, "What data are available about residues of cannabis-derived compounds in human foods (e.g., meat, milk, or eggs) that come from animals that consume cannabis or cannabis-derived compounds? Are there residue levels that should be tolerated in these foods?"
Information about the FDA's public hearing on May 31 and how to submit comments ahead of the July 2 deadline is available at the FDA website. Visit another FDA website page for FAQs about cannabis and cannabis-based products.
https://www.avma.org/News/JAVMANews/Pages/190...b3ce9f3d94
Posted May 8, 2019
In the coming months, the Food and Drug Administration will weigh whether certain food and dietary supplements containing cannabis or cannabis derivatives can be sold without violating federal law. Cannabis's potential to compromise food safety or harm animals is just one of the many issues the agency will consider.
In April, the FDA laid out its plan to study the issue, which was prompted by growing interest in FDA-regulated products derived from Cannabis sativa L. and its components, including CBD.
"We've seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things," said Scott Gottlieb, MD, then FDA commissioner, in a press release.
"We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products," added Dr. Gottlieb, who stepped down April 5.
The FDA plan features a public hearing set for May 31 to gather stakeholder input. The agency will convene an internal working group to study the issue, taking into account statutory or regulatory changes necessary to legally market the products. The working group will also look at potential public health impacts resulting from the availability of such products.
In addition, the FDA is updating its webpage to answer frequently asked questions and help the public understand how the agency's requirements apply to these cannabis and cannabis-based products. Moreover, the agency has issued several warning letters to companies marketing CBD products with unfounded claims of therapeutic benefits.
Although the 2018 Farm Bill removed hemp from the Controlled Substances Act, "Congress explicitly preserved the FDA's current authority to regulate products containing cannabis or cannabis-derived compounds," Dr. Gottlieb said.
"The only path that the (Federal Food, Drug, and Cosmetic) Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use."
As part of the public hearing and related public comment period, the FDA is interested in data and information about the safety of cannabis and cannabis-derived compounds. For instance, the FDA asks, "Are there special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class) that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds?"
Also, "What data are available about residues of cannabis-derived compounds in human foods (e.g., meat, milk, or eggs) that come from animals that consume cannabis or cannabis-derived compounds? Are there residue levels that should be tolerated in these foods?"
Information about the FDA's public hearing on May 31 and how to submit comments ahead of the July 2 deadline is available at the FDA website. Visit another FDA website page for FAQs about cannabis and cannabis-based products.
https://www.avma.org/News/JAVMANews/Pages/190...b3ce9f3d94
