Dietary Supplements

Vetting suppliers becomes ever more crucial as US-China tensions rise

18-Aug-2022 By Hank Schultz

Heightened US-China tensions have caused planners in all industrial sectors to reevaluate their sourcing arrangements. Stakeholders in the dietary supplement industry say having firm relationships with well-vetted suppliers is the best way to manage...

Youtheory announces first new product launch following its acquisition by Jamieson

16-Aug-2022 By Hank Schultz

Youtheory, a supplement brand that made its name popularizing collagen, is expanding its reach with the launch of a new line of liquid dietary supplements.

Metagenics strengthens EU presence with Nutri Advanced acquisition

16-Aug-2022 By Nicola Gordon-Seymour

UK supplements retailer, Nutri Advanced, has been acquired by Metagenics for an undisclosed sum.

CRN: Progress being made on MPL provisions in fees bill

04-Aug-2022 By Hank Schultz

Significant progress is being made on a mandatory product listing requirement that the industry can live with, CRN asserts.

Congress explores how Farm Bill could hasten CBD regulations, market development

02-Aug-2022 By Elizabeth Crawford

On Capitol Hill last week, hemp industry stakeholders and Congressional leaders frustrated by FDA’s lack of regulations for CBD and other hemp-derived compounds since the 2018 Farm Bill authorized commercial production of the crop, explored how the 2023...

DeLauro/Durbin move to split up FDA has earlier precedents, expert says

28-Jul-2022 By Hank Schultz

Splitting the food safety responsibilities off from the US Food and Drug Administration is not a new idea, said a prominent industry consultant.

Study finds supplements with dodgy ingredients still for sale years after warning letters

26-Jul-2022 By Hank Schultz

A new study from a team headed by prominent industry critic Dr Pieter Cohen, MD, found that FDA warning letters did not prevent the subsequent sale of supplements with dodgy ingredients.

CRN: Few firms will file NDIs under current guidance

21-Jul-2022 By Hank Schultz

The Council for Responsible Nutrition said that persistent problems with FDA’s NDI Draft Guidance means that few firms likely will file new notifications during the recently announced amnesty window.

Young Living warning letter points to need among MLMs to have plan to police language used by distributors

20-Jul-2022 By Hank Schultz

A warning letter sent to Young Living, a multi level marketing company specializing in essential oils, underscores the importance of having a social media monitoring program in place to avoid running afoul of regulators.

New ISSN position paper gives nutritional guidance for warfighters, first responders

19-Jul-2022 By Hank Schultz

A new sports nutrition position paper outlines nutritional recommendations for warfighters while stressing how much more research needs to be done to pin down precise deficits and requirements for troops engaged in ongoing operations.

FDA cites four more honey products for knockoff ED drugs

18-Jul-2022 By Hank Schultz

The US Food and Drug Administration has sent warning letters to four companies marketing sexual enhancement supplements ostensibly based on honey but which contained undeclared ED drugs. The warning letters were part of a ongoing enforcement effort on...

Sen Burr strips out supplement provisions from new FDA user fee bill

15-Jul-2022 By Stephen Daniells

Senator Richard Burr (R-NC), the ranking member of the Senate HELP Committee, has introduced a reauthorization of FDA User Fee Programs which does not include dietary supplement provisions.

FDA, FTC combine to tackle opiod claims in kratom warning letters

08-Jul-2022 By Hank Schultz

FDA and FTC have issued four joint warning letters to kratom companies centered on opioid claims. It’s a move that comes on the heels of FDA rejecting an NDI filing on the ingredient for the sixth time.

US ranked high in adoption of alternative therapies

06-Jul-2022 By Hank Schultz

American consumers ranked high in their use of alternative health strategies according a recently published analysis of population cohort studies

7 key takeaways from the CRN-ACI Legal, Regulatory & Compliance Summit

05-Jul-2022 By Stephen Daniells

NDIs, drug preclusions, the CBD stalemate, actions at the State level, and an impending supply chain nightmare around plastics were just some of the highlights from a recent conference in New York City.

AHPA urges stakeholders to oppose MPL provisions in FDA fees bill

30-Jun-2022 By Hank Schultz

The American Herbal Products Association is urging members and stakeholders to contact lawmakers to oppose the mandatory product listing language that has been attached to a ‘must pass’ fee reauthorization bill.

Majority of CBD products tested in study found to have at least some THC

29-Jun-2022 By Hank Schultz

A new study that sampled dozens of commercially available CBD products found detectable THC levels in 64% of them. Some levels were high enough to approach therapeutic thresholds or to potentially trigger drug test failures.

Dr Rob Wildman on NDI submissions, implementing MPL

28-Jun-2022 By Danielle Masterson

This year’s International Society of Sports Nutrition Annual Conference & Expo marked its 19th year promoting the science and application of evidence-based sports nutrition and supplementation. NutraIngredients-USA was there to hear about the latest...

NOW reveals new trick spotted on Amazon to deceive consumers about product quality

28-Jun-2022 By Hank Schultz

In an ongoing market surveillance program, supplement manufacturer NOW has revealed a new trick spotted on Amazon to deceive consumers about what a product’s testing results actually mean.

Part 2

FDA’s Welch on enforcement: ‘Sometimes you need a hammer but, at times, the hammer is not the best option’

28-Jun-2022 By Stephen Daniells

Ingredient-specific actions, as evidenced recently by warning letters to 10 firms in the sports nutrition space, are important to FDA’s regulation of dietary supplements but additional actions are hampered by having to deal with problematic ingredients...

Onnit Labs evaluates New Mood effects on college student stress

24-Jun-2022 By Asia Sherman

Health and wellness company Onnit has added a new study to its growing portfolio of clinical trials to validate the benefits of the “total human optimization” brand’s range of multi-ingredient supplements.

California weight management supplement bill advances past committee

23-Jun-2022 By Stephen Daniells

A California bill that seeks to place restrictions on the sale of some weight management supplements to minors has passed the State’s Judiciary Committee, and now moves forward to the Senate Appropriations Committee.

FDA revisits safety of CBD for use in dietary supplements, industry not satisfied

23-Jun-2022 By Asia Sherman

Last week’s meeting of the U.S. Food and Drug Administration’s Science Board did little to assuage a frustrated CBD industry that continues to call for regulation of the cannabinoid as a dietary supplement.

USPSTF’s multivitamin report: ‘Akin to studying a hammer and concluding it is unsuitable for turning a screw’

23-Jun-2022 By Stephen Daniells

The dietary supplements industry has reacted to a recent report from the U.S. Preventive Services Task Force that dismissed the potential benefits of multivitamins for the prevention of cardiovascular disease and cancer.

CHPA adds Larisa Pavlick as new Sr Director of QA and Technical Affairs

22-Jun-2022 By Stephen Daniells

Pavlick joins the Consumer Healthcare Products Association’s regulatory and scientific affairs team after almost six years at the United Natural Product Alliance (UNPA).

AHPA withdraws objections to California weight loss bill

17-Jun-2022 By Stephen Daniells

Recent amendments to a California bill that seeks to place restrictions on the sale of some weight management supplements to minors removed retail access restrictions and clarifies definitions, leading one trade association to remove its objections.

Industry stakeholders spar over whether pushing for MPL has been tactical error

16-Jun-2022 By Hank Schultz

Mandatory Product Listing can still be a good idea for industry, proponents maintain, even if the latest legislative iteration has failed to garner support from stakeholders.

Trade organizations line up against bill that includes new supplement regulations

15-Jun-2022 By Hank Schultz

Three trade organizations joined forces in opposing the FDA Safety and Landmark Advancement Act of 2022 (FDASLA), a fee authorization bill that includes provisions aimed at tightening dietary supplement regulations.

Romney's amendments to Murray/Burr bill called ‘negotiating tactic’

14-Jun-2022 By Hank Schultz

Amendments offered by Sen. Mitt Romney, R-UT, could soften some of the hardest edges in an FDA fee reauthorization bill that includes language meant to tighten the regulation of dietary supplements. But the bill still sets a very troubling precedent,...

FDA working ‘expeditiously’ to finalize NDI draft guidance sections

13-Jun-2022 By Stephen Daniells

The US Food & Drug Administration intends to release multiple draft guidance documents to the industry as smaller, discreet topics relating to New Dietary Ingredients (NDI), a senior figure said recently.

New supplement rules tacked on to bill authorizing FDA fees

10-Jun-2022 By Hank Schultz

Authors of a bipartisan bill to reauthorize FDA user fees have included provisions bearing on dietary supplements, which has stirred up a hornets nest within the industry.

FDA releases consumer resource for supplements

06-Jun-2022 By Hank Schultz

The US Food and Drug Administration has released a consumer-aimed education resource for dietary supplements.

Review calls for reassessment of upper levels for zinc intake in preadolescent children

25-May-2022 By Asia Sherman

Research published in Nutrients suggests that existing upper levels of zinc among infants and young children should be updated with a newer body of relevant evidence.

Alkemist Labs launches quality program featuring easy to read test results, verification seal for labels

24-May-2022 By Hank Schultz

Alkemist Labs has announced a new quality and transparency program featuring validated, simplified test documents that can be shared with clients and customers. It’s the culmination of a seven year development process, the company said.

Study unlocks Choline’s ‘unique role’ in boosting DHA levels during pregnancy

19-May-2022 By Stephen Daniells

Maternal intake of choline, an essential brain nutrient for mother and developing child, significantly increases DHA status, more than supplementing with DHA by itself, says a new study from Cornell University.

Walgreens becomes first to use UL Verified Mark on supplement labels

18-May-2022 By Hank Schultz

Global safety certifier UL has announced a new UL Verified Mark will debut on Walgreens brand vitamins and supplements. The new partnership was announced yesterday.

FDA reiterates that ‘FDA approved’ is a bogus phrase in most cases

11-May-2022 By Hank Schultz

The US Food and Drug Administration has issued a document reminding consumers that in only a few cases is ‘FDA approved’ a factual statement.

FDA cites 10 firms for use of ingredients flagged as illegal

10-May-2022 By Hank Schultz

In a coordinated enforcement action, FDA has sent warning letters to 10 dietary supplement companies using ingredients that have been added to its Ingredients Advisory List.

NOW marks next phase of growth with new ad campaign

09-May-2022 By Danielle Masterson

Founder Elwood Richard’s motto was that good health should be affordable–a message that laid the groundwork for the campaign.

Nature’s Sunshine joins Usana among firms relying on sales in Asia

06-May-2022 By Hank Schultz

Multilevel marketing organization Nature’s Sunshine managed to post a significant revenue increase in its first quarter earnings statement, despite supply chain challenges that caused out of stock situations and an overall net loss.

FDA slams Delta-8 THC sellers over claims

04-May-2022 By Hank Schultz

FDA came down hard on purveyors of Delta-8 THC and CBD products that were making disease claims on the substances. The Agency also reiterated the reasons it believes Delta-8 is not a suitable ingredient for products marketed as supplements.

FSMA guidance on certifying inspectors in foreign markets impacts supplement industry, observer says

03-May-2022 By Hank Schultz

FDA has issued a draft guidance on how to accredit foreign certifying bodies. The document will help clarify a highly technical aspect of the Food Safety and Modernization Act and will remind dietary supplement firms that it’s high time to get their...

Kyowa Hakko benefiting from Kirin’s support post acquisition, CEO says

02-May-2022 By Hank Schultz

Being part of the massive organization Kirin has helped Kyowa Hakko build on its legacy of innovation and quality, according to the division’s new CEO.

Enforcement discretion gives some solace to NAC space, observers say

29-Apr-2022 By Hank Schultz

FDA’s recently announced enforcement discretion policy on NAC will bring some certainty to the market. But it doesn’t answer all of the questions surrounding the ingredient, which could cause other issues later, experts said.

Guest article

Mandatory Product Listing: It Won’t “Wash the Windows” Either!

29-Apr-2022 By Steve Mister, CRN President and CEO

This week, Senators Durbin (D-IL) and Braun (R-IN) introduced S. 4090, the Dietary Supplement Listing Act of 2022, on a bipartisan basis. The legislation would create a mandatory product listing for dietary supplements, similar to the voluntary Supplement...

NPA letter makes comprehensive rebuttal to need for Durbin/Braun listing bill

28-Apr-2022 By Hank Schultz

The Natural Products Association has sent a letter to Senators Dick Durbin and Mike Braun extensively rebutting assertions made in support of their bill that requires mandatory product listing for dietary supplements.

NutraWomen Wednesday: Larisa Pavlick, VP, Global Regulatory & Compliance, UNPA

27-Apr-2022 By Danielle Masterson

Larisa Pavlick has devoted her entire career to the supplement industry. She spent nearly a decade at FDA focused on consumer safety and also experienced the full product life cycle from the development phase, through purchasing, into manufacturing, brand...