Regulation

Gaia Herbs extends open invite to FDA

Gaia Herbs invites FDA to come visit ‘any time at all’

By Asia Sherman

As part of a new campaign to showcase responsible and rigorous practices in the dietary supplement industry, Gaia Herbs has extended an open invitation to the Food and Drug Administration (FDA) to inspect its operations.

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Guest article

Beware of Bots and AI: Minimizing the risk of fraudulent claims in class action settlements

By Elizabeth Chiarello and Julie Becker, Products Liability & Mass Torts Litigation group, Sidley

In this guest article, Elizabeth Chiarello and Julie Becker from Sidley’s Products Liability & Mass Torts Litigation group, provide actionable guidance to help functional food and supplement companies minimize risks associated with a new form of fraud...

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NPA submits Citizen Petition on labeling of mushrooms & mycelia

By Stephen Daniells

The Natural Products Association (NPA) is seeking clarity on the labeling of fungi ingredients in dietary supplements, with a Citizen Petition requesting FDA to incorporate aspects of guidance from the American Herbal Products Association (AHPA).

Courtesy of Aker BioMarine

Aker Biomarine gets NDI nod from FDA for brain health ingredient

By Danielle Masterson

The Norwegian fishing and biotech company has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its Lysoveta. Under the NDI, Aker BioMarine can market Lysoveta at 1.5 grams/day for the general adult...

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Pressure mounts on FDA to regulate CBD

By Danielle Masterson

Lawmakers and stakeholders assembled for a congressional hearing on July 27 to highlight how FDA’s refusal to regulate CBD is threatening consumer access to safe products.

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Guest Article

New regulatory practices to dietary supplements in Canada endanger U.S. brand suppliers

By Aaron Skelton, President and Chief Executive Officer at Canadian Health Food Association (CHFA)

In an attempt to overhaul an already effective system, Health Canada's new regulatory measures for dietary supplements are inadvertently causing more harm than good – not only to Canadian consumers, retailers, and brands but also to U.S. suppliers.

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Guest Post

Embracing the ‘Art of the Possible’ in Novel Food Regulation

By David Hardstaff and John Binns

In this guest article, David Hardstaff and John Binns, Partners at BCL Solicitors, discuss a high-profile investigation into banned muscle-building drugs which highlights issues with the novel foods regime impacting the CBD industry.

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All eyes on Dietary Supplement Master Files

By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...

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FTC seeks to crack down on fake reviews in the digital age

By Danielle Masterson

The Commission noted the proliferation of generative AI will likely make it easier for bad actors to write fake reviews. However, the FTC's plan to impose hefty fines may be enough to deter deceptive practices.

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

By Stephen Daniells

From a proposed reorganization of the Food & Drug Administration to progress (or not) on the NMN situation, there’s a lot going on in the dietary supplements industry. We caught up with Daniel Fabricant, PhD, president and CEO of the Natural Products...

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Microbiome Briefing

The Growth of Probiotics in Europe

By Stephen Daniells

This year opened with news that France has joined the list of European countries that will allow the use of the term “Probiotic”. As dominoes continue to fall, we look at the opportunities for probiotics across the bloc, particularly supplements in the...

Fungi Perfecti responds to ‘puzzling opinion’ in Nammex petition

Fungi Perfecti responds to ‘puzzling opinion’ in Nammex petition

By Asia Sherman

Fungi Perfecti, a supplier of mycelium-based supplements, has written an open letter to address the citizen petition filed by mushroom extract company Nammex, which requested that the Food and Drug Administration act to ensure proper labeling of fungi...

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Guest Article

Ex-Health Canada NHP DG: ‘Cannabis is Canada’s New Wild West’

By Adam Gibson, President, True Moderation

When it comes to regulating CBD and cannabis, Canada is an extreme cautionary tale for the US, says Adam Gibson, the former Director General of Health Canada’s Non-prescription and Natural Health Products Directorate.

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Guest article

Health Canada’s proposal on cost recovery for Natural Health Products raises questions

By Katrina Coughlin, Laura E. Gomez, Jon-Paul Powers, PhD, Lewis Retik, & Lauren Richardson - Gowling WLG

On May 12, 2023, Health Canada published a proposal detailing cost recovery fees for natural health products (NHPs). While there is a lot of information to digest in Health Canada's proposal, the proposed fees detailed below raise questions regarding...

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BAPP SOP update: Adopters say guidance is moving commerce needle

By Danielle Masterson

The Botanical Adulterants Prevention Program (BAPP) Best Practices Standardized Operating Procedure (SOP) for the Disposal / Destruction of Irreparably Defective Articles (IDAs) is a voluntary standard to remove “irreparably defective” substances that...

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NY Assembly passes bill targeting weight loss, muscle building supps

By Stephen Daniells

Efforts to restrict the sale of some dietary supplements to minors in New York State took a step forward this week as the State’s Assembly passed AB 5610-D, a bill that limits access to some dietary supplements for weight loss or muscle building for people...

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