CBD Company Receives Joint Warning Letter from FTC and FDA

October 25, 2019 08:00:10

This Tuesday, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) posted a joint warning letter to CBD company Rooted Apothecary LLC. The letter cautioned the Naples, Florida-based company against illegally selling CBD-infused products, and making unsubstantiated claims that their products could treat teething pain and earaches in infants, ADHD, Parkinson’s, Alzheimer’s and a host of other diseases.

CBD has been a subject of controversy for the past few years. Tons of people swear that the compound gave them relief from a variety of medical conditions, but there is very little scientific research and evidence to prove this. Furthermore, cannabidiol is derived from the cannabis plant, most famous for the psychotropic high users experience after using it. Last year’s Farm Bill allowed the farming of cannabis, but only if there’s less than 0.3% THC, the component that causes cannabis’ high.

The industry still has little regulation, and some sellers have taken to making unsupported claims to sell more of their products. “Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” said Acting FDA Commissioner Ned Sharpless, M.D., “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”

He says that it is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like women and children. “We’ve sent out numerous warning letters that focus on matters of significant public health concerning CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision making remains our top priority.” Sharpless adds that the FDA appreciates the FTC’s support in its bid to protect consumers from “fraudulent” CBD products.

Rooted Apothecary LLC had used product pages, social media websites, and its online store to make unfounded claims about its CBD products. Some of its products were marketed as dietary supplements despite agency regulation forbidding that. Under the Federal Trade Commission Act, it is illegal to advertise that a product can prevent, treat, or cure human diseases unless the advertiser possesses competent and reliable scientific evidence. To make or exaggerate such claims without sufficient scientific evidence to back the claims would violate the FTC Act.

The FTC and FDA have requested a response from Rooted Apothecary LLC within 15 working days stating how the company will correct the violations. Failure to correct the violations may result in legal action, including seizure and injunctions. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order may require that a company pay back money to consumers.

Analysts believe that more established CBD companies like IONIC Brands Corp. (CSE: IONC) (OTC: IONKF) and Organigram Holdings Inc. (TSX.V: OGI) (NASDAQ: OGI) have compliance teams that keep them safe from running afoul of federal regulators. Newer companies can do well to learn from those that came before them if their businesses are to survive.

About CBDWire

CBDWire (CBDW) is a specialized information provider focused on (1) reporting CBD-related news and updates, (2) releasing CBDNewsBreaks crafted to keep investors abreast of the latest and greatest in the CBD market, (3) refining and enhancing corporate press releases, (4) delivering end-to-end distribution and social media services to client-partners and (5) constructing effective corporate communication solutions based on the unique requirements of CBD companies. CBDW is exclusively positioned in the burgeoning CBD sector with a proven team of journalists and researchers working to deliver high quality content to an expansive target audience of investors, consumers and industry news outlets. Our dissemination network of over 5,000 downstream distribution points allows us to deliver unparalleled reach, visibility and recognition to companies operating in both cannabidiol and the wider cannabis space. CBDWire (CBDW) is where CBD news, content and information converge.

To receive instant SMS alerts, text CBDWire to 21000 (U.S. Mobile Phones Only)

For more information please visit https://www.CBDWire.com

Please see full terms of use and disclaimers on the CBDWire website applicable to all content provided by CBDW, wherever published or re-published: https://CBDWire.com/Disclaimer

Do you have a questions or are you interested in working with CNW? Ask Our Editor

Denver, Colorado
303.498.7722 Office