Specialty Food Magazine

FALL 2019

Specialty Food Magazine is the leading publication for retailers, manufacturers and foodservice professionals in the specialty food trade. It provides news, trends and business-building insights that help readers keep their businesses competitive.

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FALL 2019 81 Virginia, Colorado, and Kentucky. CBD makes farming much more profitable. However, farmers need federal guidance so they are not operating outside of the law. 3. Manufacturers and Labs Many demonstrated that their processes for extracting and manufacturing CBD were safe. Several consumer groups con- tradicted this, presenting data that showed the percentage of CBD in foods ranging from 0 to 0.20 (similar to cannabis). The Clean Label Project testified that there are systematic quality control and safety issues, with high incidences of heavy metals and pesticides in products. 4. Medical Associations, Doctors, and Patients • Many attested to the health benefits of CBD, including representatives from the Epilepsy Foundation, Alzheimer's Association, and Parkinson's Foundation. • Consumer Reports presented research showing an interest in CBD and cannabis products, including: » 26 percent of Americans had tried CBD in the past two years » 63 percent said CBD had helped with anxiety » 36 percent said they used cannabis and/or CBD instead of opioids All presentations are available on the FDA website at https://www.fda.gov/news-events/fda-meetings-conferences-and- workshops/scientific-data-and-information-about-products-con- taining-cannabis-or-cannabis-derived-compounds Where Do We Go From Here After the public hearing, the industry and consumers were given six weeks to submit written statements. Thousands were submitted. FDA's Internal Working Group will review this information. In its statement, Specialty Food Association stressed that a "deliberate and rapid federal approach is necessary. SFA and its members are concerned that delays in completing the regulatory process will unnecessarily and unfairly undercut an important new market and the possible commercial income for SFA members." SFA also pointed out that FDA regulation would make the products safer, stating, "A delay will also allow potentially danger- ous foods to be on the market." As more and more CBD products come onto the market, man- ufacturers, retailers, and foodservice operators continue to struggle with whether they should add these products to their repertoire. Consumers demand them, but the federal government deems them illegal. It is a question that hopefully will be answered soon. The Federal/State Conundrum Products containing THC and CBD are illegal on a federal level. FDA has not approved the products as GRAS (generally regarded as safe) and they cannot legally enter interstate commerce. Complicating the issue is the fact that CBD and THC have been studied and approved as drugs by the FDA. FDA has formed an internal working group to study the issues. Critical questions include: • How much CBD is safe to consume in one day? • How do lotions, beverages, and oils interact? • How does CBD affect pregnancy? At the FDA's public hearing entitled, "Scientific Data and Information about Products Containing Cannabis and Cannabis- Derived Compounds," on May 31 in Silver Spring, Md., Acting Commissioner Ned Sharpless made it very clear that FDA was not close to approving CBD products for sale. Sharpless said, "Some compounds found in cannabis—spe- cifically, CBD and THC—have been studied and even approved as drugs. It's important to note that the Federal Food, Drug & Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce. That includes both substances that have been approved as drugs, as well as compounds for which substantial clini- cal investigations have been instituted. "What that means is that, under current law, CBD and THC cannot lawfully be added to a food or marketed as a dietary supple- ment." Speakers Sound Off at FDA Public Hearing More than 140 speakers presented on May 31, including academ- ics, agricultural specialists, manufacturers, associations, retailers, distributors, state government officials, patients, and consumers. Speakers represented organizations as diverse as the John Hopkins University School of Medicine to the Natural Products Association to Community Alliances for Drug-Free Youth. A panel of eight FDA officials listened to the presentations and questioned the present- ers. Approximately 500 sat in the live audience, and hundreds more watched online. There were four basic viewpoints, with a lot of variations within each: 1. Academic and Scientific Community There is not enough research for FDA to make an informed decision. These viewpoints were presented by John Hopkins School of Medicine, the University of Mississippi National Center for Natural Products Research, and the University of Wisconsin, among others. 2. Government Officials and Various Associations Many stressed the importance of hemp production to agri- culture in their state, especially officials from North Carolina, Ron Tanner is vice president, philanthropy, government, and industry relations for the Specialty Food Association. article bug 81 FALL 2019

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