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.
Two of the dietary supplement industry’s most vocal critics in Congress – Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) – have written to the FDA to express concerns about proposed changes to the Office of Dietary Supplement Programs (ODSP).
Helaina is pioneering modern nutrition with breast milk proteins developed outside the body via precision fermentation. The biotech company is writing the safety playbook on novel bioactive proteins and to help with this, Helaina hired a nutritional sciences...
The US Food and Drug Administration has selected James “Jim” Jones as the first Deputy Commissioner for Human Foods to lead the Agency’s proposed unified Human Foods Program (HFP).
A new paper in JAMA Cardiology that criticizes the use of structure/function claims on omega-3 dietary supplements is “fraught with inaccuracies and never should have made it through the peer review process”, says the Global Organization for EPA and DHA...
The recent congressional hearing about CBD and subsequent ‘historic’ bicameral Request for Information (RFI) shows that hemp-derived CBD for use in dietary supplements has finally got the attention of Congress, said cbdMD’s CSO.
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...
The class action lawsuit alleging that Walmart’s Spring Valley 1000 mg Fish Oil supplement is instead falsely labeled fish waste processed using industrial solvents and ethanol is moving forward.
The Council for Responsible Nutrition (CRN) has written to the US Food & Drug Administration urging the agency to put resources behind any dietary supplement master file framework, or rethink prioritizing a master files guidance.
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).
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...
The European Commission has discussed the creation of an EU working group to bring some regulatory harmonisation over use of the term ‘probiotic’ across Member States.
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.
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.
Trade associations have long advocated for dietary supplements to be added to the list of qualified medical expenses to allow consumers to decide how to spend their pre-tax dollars.
The FDA has declined a request from South Carolina Congressman Jeff Duncan for a public hearing on NMN – nicotinamide mononucleotide – in dietary supplements.
Lisa Parks, RPh joined the Consumer Healthcare Products Association with over three decades of experience practicing pharmacy, managing organizational change initiatives at the FDA and overseeing scientific and regulatory affairs, today she embarks on...
The Board of the American Herbal Products Association will oppose FDA proposals to reorganize its dietary supplements program into a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.
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.
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...
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.
FDA’s recent proposal to relocate the Office of Dietary Supplement Programs (ODSP) to a new Office of Food Chemical Safety, Dietary Supplements, and Innovation, is disturbing, says UNPA’s Loren Israelsen.
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...
The dietary supplement industry is expressing concern over a proposed update to a Food and Drug Administration (FDA) reorganization that would relocate the current Office of Dietary Supplement Programs (ODSP) to a new office under its “Risk Management...
The ability for consumers to use pre-tax dollars for healthcare related expenses to purchase dietary supplements may be edging closer as legislation is about to be introduced in Congress to expand eligibility of dietary supplements in HSA and FSA accounts.
The need for certainty and preparedness emerged as crosscutting priorities among the general counsels, regulatory experts and research scientists gathered last week in New York City for the 11th Annual Legal, Regulatory and Compliance Forum on Dietary...
Industry experts and trade groups are decrying the World Health Organization’s International Agency for Research on Cancer’s pending addition of aspartame to a list of possible carcinogens for humans as unscientific and politically motivated.
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, 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...
The US Food and Drug Administration recently released a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials.
North American Reishi Ltd (“Nammex”) has filed a Citizen Petition with the FDA on the labeling and sale of food and supplements containing fungal ingredients.
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.
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...
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...
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...
With the ongoing theme of safety, FDA recently addressed CBD. While offering up several potential scenarios, the Agency said the CBD marketplace ultimately rests in the hands of Congress.
Probiota Americas is just over two weeks away. With key scientific and business insights into microbiome modulation to support women’s health, LBPs, and quorum sensing, don’t wait to register!
Probiota Americas is just over two weeks away. With key scientific insights into the category’s most disruptive technology – A.I., CRISPR, and -omics – and a look at the microbiomes of centenarians, don’t wait to register!
A nonprofit accreditation body, Empowered by Evidence (EBE), gave an impassioned presentation to the audience of Vitafoods 2023, calling for companies to promote better standards in industry science.
Consumer interest in novel experiential delivery forms is driving a lot of growth for dietary supplements, but context is an important regulatory consideration, experts noted during a recent NutraIngredients-USA webinar.
The U.S. Food and Drug Administration (FDA) issued an advisory this week warning of adverse event reports related to selective androgen receptor modulators (SARMs). In the letter, the agency also takes issue with online vendors and social media influencers...
NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.
