FDA warns Cannafyl for CBD claims
Regulatory News | 09 March 2021 |
The US Food and Drug Administration has warned a company marketing cannabidiol products for its advertising claims about the drops and salves it markets and sells online.
Scottsdale, AZ-based Cannafyl made claims that cannabidiol (CBD) “helps manage cancer growth,” in an October 2020 blog post on the Cannafyl website entitled “CBD for Breast Cancer,” according to FDA’s Center for Drug Evaluation and Research (CDER). In its warning letter, CDER also cites claims in the blog post that “full spectrum CBD,” as Cannafyl characterizes its products, “Inhibits tumor cell growth and cancer growth...[and] kills cancer cells.” That blog post is no longer available on Cannafyl’s website. Six new blog posts dated 9 March 2021 address other topics, such as the use of CBD oil for panic attacks and “muscle relaxation.”
Other claims Cannafyl made included an intimation that CBD “might positively affect COVID-19.” In Facebook posts and promotional information on Cannafyl’s website, the firm made claims that that its topical salve would “help relieve” neuropathy and psoriasis and that CBD may help treat opioid addiction, epilepsy, multiple sclerosis, Parkinson’s disease, infections, heart disease and diabetes, among other ailments.
In the letter, FDA made clear that the CBD products marketed by Cannafyl are not nutritional supplements, but rather unapproved and misbranded drugs. “The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
The pet formulations of CBD products sold by Cannafyl also garnered several paragraphs in the warning letter. There, FDA itemized the claims that CBD might help treat or prevent cancer and help anxiety and pain in dogs.
FDA issued a spate of warning letters in late 2020, with five coming in December to marketers of CBD products that were “especially concerning from a public health perspective” because of nasal, ophthalmic or inhaled routes of administration, according to a 22 December FDA post.
In November 2019, FDA issued 15 warning letters in one fell swoop. In announcing that raft of warnings, FDA also said it was exploring “potential pathways” for lawful marketing of CBD products. Setting aside cannabidiol products approved to treat certain childhood seizure disorder, FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said at the time that a questions remained regarding the safety of CBD products. Still, she said, “We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
FDA has last updated its website with a post in January 2021 pointing to its data collection efforts on use and safety considerations for CBD. The direction the agency will take under the Biden administration remains unknown.
Cannafyl was given 15 working days from the 1 March letter date to respond to FDA.
FDA
Scottsdale, AZ-based Cannafyl made claims that cannabidiol (CBD) “helps manage cancer growth,” in an October 2020 blog post on the Cannafyl website entitled “CBD for Breast Cancer,” according to FDA’s Center for Drug Evaluation and Research (CDER). In its warning letter, CDER also cites claims in the blog post that “full spectrum CBD,” as Cannafyl characterizes its products, “Inhibits tumor cell growth and cancer growth...[and] kills cancer cells.” That blog post is no longer available on Cannafyl’s website. Six new blog posts dated 9 March 2021 address other topics, such as the use of CBD oil for panic attacks and “muscle relaxation.”
Other claims Cannafyl made included an intimation that CBD “might positively affect COVID-19.” In Facebook posts and promotional information on Cannafyl’s website, the firm made claims that that its topical salve would “help relieve” neuropathy and psoriasis and that CBD may help treat opioid addiction, epilepsy, multiple sclerosis, Parkinson’s disease, infections, heart disease and diabetes, among other ailments.
In the letter, FDA made clear that the CBD products marketed by Cannafyl are not nutritional supplements, but rather unapproved and misbranded drugs. “The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
The pet formulations of CBD products sold by Cannafyl also garnered several paragraphs in the warning letter. There, FDA itemized the claims that CBD might help treat or prevent cancer and help anxiety and pain in dogs.
FDA issued a spate of warning letters in late 2020, with five coming in December to marketers of CBD products that were “especially concerning from a public health perspective” because of nasal, ophthalmic or inhaled routes of administration, according to a 22 December FDA post.
In November 2019, FDA issued 15 warning letters in one fell swoop. In announcing that raft of warnings, FDA also said it was exploring “potential pathways” for lawful marketing of CBD products. Setting aside cannabidiol products approved to treat certain childhood seizure disorder, FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said at the time that a questions remained regarding the safety of CBD products. Still, she said, “We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
FDA has last updated its website with a post in January 2021 pointing to its data collection efforts on use and safety considerations for CBD. The direction the agency will take under the Biden administration remains unknown.
Cannafyl was given 15 working days from the 1 March letter date to respond to FDA.
FDA
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