This webinar provides an overview of dietary supplement current good manufacturing (cGMP) requirements for hemp-CBD products. Legal and industry experts provide strategies and resources to comply and document compliance with  federal manufacturing requirements designed to ensure supplement product quality and safety.

This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that have been the primary focus of FDA inspections. This knowledge will assist businesses in better allocating and directing their compliance resources.

The Oregon Department of Justice (OR DOJ) has temporarily adopted a rule declaring it “unfair and deceptive” (and thus unlawful) to represent that any product “will prevent, treat, diagnose, mitigate, or cure coronavirus, COVID-19 or a related condition, without first having competent and reliable scientific evidence upon which to base a reasonable belief in the truth of the representation.” The temporary rule is effective for six months, until October 14, 2020.

In January 2020, Δ9-tetrahydrocannabinol (Δ9 THC) was added to the Proposition 65 list as a chemical known to cause reproductive toxicity. While Δ9 THC is present at only trace levels in hemp products, companies marketing hemp products in California should evaluate whether a warning is needed for these products. Also of concern, are other chemicals on the Proposition 65 list that may be used in the cultivation and processing of hemp and marijuana, such as the pesticides myclobutanil and carbaryl, for which some cannabis businesses have received Proposition 65 notices.

Marijuana smoke was added to the Proposition 65 list in June 2009 as a chemical known to the State of California to cause cancer. In January 2020, cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9 THC) were both added to the Proposition 65 list as chemicals known to cause reproductive toxicity. In addition to marijuana smoke and Δ9 THC, other chemicals on the Proposition 65 list that may be used in the cultivation and processing of cannabis, such as the pesticides myclobutanil and carbaryl, must be considered when cannabis businesses are determining compliance to this regulation.

AHPA and the Council for Responsible Nutrition (CRN) filed joint comments last week to reiterate significant concerns to the Oregon Department of Justice (OR DOJ) about a Proposed Rule that would create a private right of action for opportunistic plaintiffs' lawyers motivated by the potential for recovery rather than the public interest.

AHPA has reported to the U.S. Department of Agriculture (USDA) a host of supply chain issues submitted by members and others in the herbal community. The information submitted to USDA reports on shortages or delivery disruptions of a variety of ingredients, supplies, and services. AHPA also continues to collect supply chain data to inform the industry, regulators and lawmakers.

Established in 2006, the annual AHPA Awards acknowledge individuals and organizations that help further AHPA's goal of promoting the responsible commerce of herbs and herbal products.

2020 AHPA Award Winners

• Herbal Hero Award: Wilson Lau, Nuherbs
• Herbal Industry Leadership Award: Verdure Sciences
• Herbal Insight Award: Appalachian Beginning Forest Farmer Coalition
• Visionary Award: Dr. Edward K. Alstat (posthumous)

The April 2020 AHPA Report covers COVID-19, including a message from AHPA President Michael McGuffin, free resources and information for the herbal community and a summary of recent federal announcements about FDA inspections and supplement manufacturers and employees being designated as essential.

The U.S. dietary supplement industry commends the Food and Drug Administration (FDA) for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2. In February, the industry issued strong warning to companies and consumers to avoid marketing or using dietary supplements that are presented as treating, curing or preventing COVID-19.