AHPA Alerts

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.

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 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.

This issue of the IADSA Newsflash covers the European Commission's draft regulation directed at botanicals containing hydroxyanthracene derivatives (HADs), Belgium recently published guidance on the analysis for four new plants, Ireland survey of cannabidiol (CBD) products that found a majority were not in compliance with various regulations, Norway's risk assessment of caffeine and more.

Revised guidance provides numerous and significant additional details in identifying essential critical infrastructure workers and sectors in several categories, including, among others, healthcare, law enforcement, transportation, and food and agriculture.

Federal, state, and local governments’ actions to address the novel coronavirus and COVID-19 have consistently included recommendations promoting or directives requiring social distancing as a key protective measure to minimize community spread of this disease. In making stay-at-home recommendations or issuing shelter-in-place orders, health agencies and other official bodies have identified certain industries as “essential businesses” or “critical infrastructure” whose employees and operations are (or should be) exempt from these recommendations and directives.

The U.S. Food and Drug Administration (FDA) convened a teleconference meeting on March 18 (FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19)), which was attended by AHPA president Michael McGuffin and by representatives of AHPA’s general counsel, Kleinfeld, Kaplan & Becker, LLP.