CBA to FDA: CBD regulation has to be addressed immediately
In letters to Senator Ron Wyden of Oregon, the chairman of the Senate Committee on Finance, and Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, the Consumer Brands Association reiterated on July 22 its demand for immediate government action on cannabidiol (CBD) regulation.
In a correspondence addressed to Dr. Woodcock, Betsy Booren, the senior vice president, regulatory affairs at CBA, expressed that the current FDA position on CBD products is ineffective and that a regulatory framework is imperative for CBD products in order to safeguard consumers, guarantee product safety and transparency, set boundaries for lawful product innovation and distribution in interstate commerce, and offer manufacturers of these products with the necessary clarity.
According to Ms. Booren, the FDA is sticking to its stance that foods and dietary supplements containing CBD cannot be sold under the Food, Drug, and Cosmetics Act’s exclusionary clauses and that using these products could pose major safety risks.
As of right now, if a new dietary ingredient, food, or beverage has been investigated or approved as a drug—as CBD has—it is illegal for it to be sold in interstate commerce under the FDCA. Although it is within its power to exempt certain products from this ban, the FDA has not yet done so in the case of CBD.
Nonetheless, since Congress approved hemp and goods derived from it in the 2018 agricultural bill, CBD products are made and used lawfully in the United States. Currently, state agencies rather than federal ones are in charge of regulating these goods. Because of this, goods made in one state might not be shipped to another for sale, and state laws governing labeling, marketing, and manufacture might vary significantly.
According to Ms. Booren, “Consumer Brands believes Americans should know the products they purchase are safe and of consistent quality.” State legislatures are enacting their own laws in the absence of FDA leadership. 38 states now have 135 proposals that further complicate the various CBD laws that are already in place.Regretfully, state laws pertaining to CBD, although well-meaning, have resulted in a disorganized and contradictory regulatory framework that is unable to provide consistent standards for the secure creation, manufacturing, labeling, and promotion of these goods.
According to Ms. Booren, federal intervention was also required to dispel common consumer misconceptions, including as the idea that the FDA already regulates CBD.
According to a recent survey by Consumer Brands, 74% of American consumers either don’t know or mistakenly believe that CBD is controlled, according to Ms. Booren. “The industry is expanding, and Americans are utilizing goods without FDA supervision and without having a solid grasp of CBD. Customers gave themselves an average score of 3.3 when asked to rate their level of understanding of CBD on a scale of 1 to 10. The FDA should act quickly to close this information gap and address the absence of federal regulation.
Dr. Woodcock received six stakeholder requests on CBD from Ms. Booren.
In order to ascertain the safety of CBD products, the FDA must first give an update on the present status of the scientific research and offer a road map for locating and filling in any data or information gaps.
Second, the FDA ought to set up a system of regulations requiring producers of consumer packaged goods to report any items containing CBD to the organization and provide safety information for FDA examination.
Third, the FDA should provide an update on its progress toward establishing a regulatory framework for CBD products and opportunities for stakeholders to share their knowledge and perspectives.
Fourth, the FDA should provide technical assistance to members of Congress in their efforts to ensure a timely development of a regulatory framework.
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Fifth, the FDA and other federal agencies should continue to take enforcement actions against bad actors to remove unsafe CBD-containing products and those making misleading claims.
And sixth, while the new regulatory framework is being developed, the FDA should work with stakeholders to develop a plan that may be implemented to make certain those products currently in the market are subject to the new regulatory framework.
Jen Daulby, senior vice president, government affairs at CBA, supported Senator Wyden’s efforts to advance the Hemp Access and Consumer Safety Act (S 1698) in a letter to him that echoed these same imperatives and concerns.
On May 19, Mr. Wyden presented the legislation on behalf of himself and Senators Jeff Merkley of Oregon and Rand Paul of Kentucky. The law sought to guarantee that goods derived from hemp would be subject to FDA regulation, much like other permissible goods included in foods, beverages, and dietary supplements. The bill attempted to find a legislative solution to what was becoming recognized as a regulatory Gordian knot.