Vitafoods Insights is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

North America regulation round-up: What’s new on the regulatory landscape for nutraceuticals?

Article-North America regulation round-up: What’s new on the regulatory landscape for nutraceuticals?

© iStock/hapabapa North America regulation round-up: What’s new on the regulatory landscape for nutraceuticals?
From a Canadian directive on gene-edited plants to US guidance outlining best compliance with food traceability requirements, Vitafoods Insights gives an overview of the latest regulatory updates from across North America.

Regulations on infant formula and other foods for special dietary purposes to be extended

On 22 May, Health Canada announced a strategy to address shortages of infant formula and other foods for special dietary purposes by extending an interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages.

The agency stated its commitment to initiate work on the modernisation of the regulations for infant formula and other foods for a special dietary purpose; there are plans for a public consultation in autumn 2023.

FDA publishes compliance guide on Food Traceability Rule for small entities

On 18 May, the US Food and Drug administration (FDA) published its “Small Entity Compliance Guide for the Food Safety Modernisation Act (FSMA) Food Traceability Rule”. The guide describes the requirements of the traceability regulation to assist small entities, including farms and small businesses, in complying with the applicable recordkeeping requirements.

The FSMA Food Traceability Rule was issued in November 2022; the compliance date for recordkeeping requirements is 20 January 2026.

Health Canada publishes comparative analysis of fees for regulated natural health products

On 12 May, Health Canada published an analysis looking at how other regulators treat natural health products when establishing a cost-recovery regime. Regulatory activities incur costs to the government and provide benefits to the industry that is being regulated; the practice of cost recovery – charging industry fees to cover a portion of these costs – helps to ensure that these activities are not funded solely by taxpayers.

The agency examined the practices of four regulators: the European Medicines Agency; Australia's Therapeutic Goods Administration; the FDA; and the UK’s Medicines and Healthcare products Regulatory Agency.

While different countries’ regulatory regimes are not directly comparable, Health Canada states that it is important to be aware of, and understand how, other regulators treat natural health products when setting up a cost-recovery regime.

Canada updates guidance on assessment of gene-edited plants

On 3 May, the Canadian Food Inspection Agency (CFIA) published “Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA”. The updated guidance makes clear which plants – whether developed via conventional breeding or through new plant breeding innovation methods – require assessment from the CFIA before being released into the environment.

Last May, Health Canada released guidelines regarding the approval of plants with non-novel traits, prompting the organic sector to ask for more clarification on how gene-edited varieties would be kept separate from genetically modified organisms (GMOs).

The announcement means that varieties or cultivars developed with gene-editing will not be considered a GMO under Canadian rules, so long as the resulting plant does not possess new traits and have the potential to negatively impact the environment.

Canada to enable use of L-alpha-glycerylphosphorylcholine as supplemental ingredient

On 17 April, Health Canada's Food Directorate assessed L-alpha-glycerylphosphorylcholine (also known as alpha-GPC or choline alfoscerate) as a supplemental ingredient. It concluded that information related to the safety of the ingredient supports its safe use in supplemented foods as a source of supplemental choline, provided that levels of use do not exceed the previously established maximum levels for choline, and that certain labelling requirements are met.

© iStock/CasarsaGuru What’s new on the regulatory landscape for nutraceuticals?

Health Canada proposes enabling the use of L-alpha-glycerylphosphorylcholine as a source of supplemental choline by modifying the choline entry in its “List of permitted supplemental ingredients”.

Bills re-introduced to regulate hemp-derived CBD

On 17 March, the US introduced two pieces of legislation aimed at creating potential pathways for regulation of cannabidiol (CBD) products.

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilisation Act of 2023 would make hemp, cannabidiol derived from hemp, and other hemp-derived products lawful for use as a dietary supplement unless otherwise directed by the FDA.

The CBD Product Safety and Standardisation Act directs the FDA to regulate CBD as the agency would for other food ingredients, setting requirements for quality and labelling, among other areas.

FDA publishes guidance on medical foods

On 15 March, the FDA published its “Guidance for Industry: Frequently Asked Questions About Medical Foods – Third Edition”. This guidance, which is an update of that published in May 2007, is intended to provide industry with a convenient place to find answers to frequently asked questions about the definition of, and regulations for, medical foods.