June Regulatory Focus: Nutrition in Health and Disease Management
| July 08, 2022 | By
Feature articles from June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to US Dietary Supplement Health and Education (DSHEA) and the FDA and Federal Trade Commission (FTC) regulations on dietary supplements for the treatment or prevention of certain mental health disorders.
Security, Disruptions and Reactive Policy
China has significantly improved its overall food security situation 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 standards 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. Consequently, no major food safety incidents have been reported in recent years. However, due to the small-scale agricultural production system and the food processing industry, violations of regulations and standards, as well as sporadic cases of foodborne illnesses, have been reported. The authors note that although food security issues cannot be eliminated, food security remains a long-term priority in China.
In Supply Chain Disruptions: Temporary FDA Guidelines and 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 nutrition labeling and preventative controls, as well as verification of on-site audit requirements. The authors suggest that these initiatives have been a formative experience for the agency, providing it with valuable real-world experience with agile policy-making processes that could help it deal with future crises and disruptions.
Legislative updates and agency oversight
The dietary supplement industry has grown significantly since the Dietary Supplements, Health and Education Act (DSHEA) was passed nearly 30 years ago, but legislative reform has not kept pace. rhythm. In the proposed updates, reference to the legislative reform of dietary supplements, 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 loophole in FDA enforcement authority, exclusion of pharmaceutical items, use of CBD in foods and supplements, third-party inspections for supplement facilities, and ensuring the distribution of truthful scientific information about the benefits of dietary supplements.
In Managing the Regulation of Mental Health Claims in the Age of COVID-19, Pippins Raqiyyah and Danait Mengist provide an overview of FDA and FTC regulations and enforcement activities regarding dietary supplements for the treatment or prevention of stress, depression, and other mental health disorders. Consumer demand for dietary supplements to address mental health issues has increased during the pandemic, as has federal scrutiny of companies promoting these benefits. The authors provide guidance for companies interested in promoting these products, such as avoiding claims linking a product’s benefits or effectiveness to specific mental health conditions or implying that a product can treat conditions long-term or chronic. They suggest companies focus on claims highlighting symptoms often associated with non-disease states, such as stress and frustration, and ensure that each claim is sufficiently supported by competent and reliable scientific evidence.
More content on nutrition in health and disease management will be released in July. It will focus on guidelines for ready-to-use therapeutic foods, drug exclusion and public health, nutrition and health claims in the EU and personalized nutrition.
Coming in Regulatory guidance
What’s new in July?
July’s articles will focus on Regulatory Affairs Mentorship.
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