Feature Articles| 08 July 2022 | By
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Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.
Safety, disruptions, and responsive policy
China has improved its overall food safety situation significantly since the melamine crisis in 2008, write Junshi Chen and Chunzhu Wu in An update of China’s food safety regulatory framework. The national food safety standard system is now in line with the Codex system, food safety inspection has been strengthened, and the food industry has made safety a high priority. As a result, no major food safety incidents have been reported in recent years. However, due to the small-scale agriculture production system and food processing industry, violations of regulations and standards, as well as sporadic occurrences of food-borne disease, have been reported. The authors note that although food safety issues cannot be eliminated, food safety remains a long-term focus in China.
In Supply chain disruptions: FDA guidance and temporary policies, Tony Subketkaew and Joanna Pearce describe how the FDA has addressed pandemic-related supply chain disruption by allowing regulatory flexibility through temporary policies for certain nutritional labeling and preventive controls, as well as verification of onsite audit requirements. The authors suggest these initiatives have been a formative experience for the agency, providing it with valuable real-world experience with agile policymaking processes that could help it address future crises and disruptions.
Legislative updates and agency scrutiny
The dietary supplement industry has expanded considerably since the passage of the Dietary Supplement Health and Education Act (DSHEA) almost 30 years ago, but legislative reform has not kept pace. In Proposed updates hint at dietary supplement legislative reform, Krista Hekking and Miriam Guggenheim discuss six key legislative updates proposed by the FDA, industry, and consumer groups that suggest reform is on the horizon for DSHEA. The proposals address mandatory product listing, closing the loophole in FDA enforcement authority, drug article exclusion, use of CBD in foods and supplements, third-party inspections for supplement facilities, and ensuring distribution of truthful scientific information about the benefits of dietary supplements.
In Managing regulation of mental health-related claims in the COVID-19 era, Raqiyyah Pippins and Danait Mengist provide an overview of the FDA and FTC’s regulations and enforcement activities around dietary supplements for treating or preventing stress, depression, and other mental health disorders. Consumer demand for dietary supplements to address mental health concerns has increased during the pandemic, as has federal scrutiny of companies promoting such benefits. The authors provide takeaways for companies interested in promoting these products, such as avoiding claims linking a product’s benefits or efficacy to specific mental health disorders or that imply a product can address long-term or chronic conditions. They suggest companies focus on claims highlighting symptoms that are often associated with nondisease states, such as stress and frustration, and ensure each claim is adequately substantiated with competent, reliable scientific evidence.
More content on nutrition in health and disease management will be published during July. It will focus on ready-to-use therapeutic food guideline, drug preclusion and public health, nutrition and health claims in the EU, and personalized nutrition.
Upcoming in Regulatory Focus
What’s coming in July?
Articles during July will focus on Mentorship in regulatory affairs.
And August?
Chemistry, manufacturing, and controls regulatory issues is the topic for the August issue. The submission date for articles is 29 July 2022.
Call for articles
September issue
The topic for September will be Risk assessment and mitigation. The submission due date for articles is 1 August 2022.
October issue
The topic for October will be OTC regulatory issues. The submission due date for articles is 1 September 2022
Upcoming in RF Quarterly
Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The most recent issue, focusing on software as a medical device, is available.
Topics through 2022 will be:
- Strategy in regulatory affairs (September)
- Artificial intelligence (December)
To contribute to these upcoming issues, email rmatthews@raps.org
Previous issues of RF Quarterly
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