Food And Drug Administration

Experts advocate for new quality control position within C-suite

24-Jan-2024 By Claudia Adrien

Industry experts propose the creation of a new executive position within organizations to help combat a rise in Food and Drug Administration citations against supplement companies who don’t meet quality control standards.

New year, same problem: FDA issues tejocote root warning, finding the supplements adulterated with poisonous plant

04-Jan-2024 By Danielle Masterson

The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant.

Sens. Durbin & Blumenthal express concerns over proposed changes to FDA's Supplement Office

26-Aug-2023 By Stephen Daniells

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).

Jim Jones named as 1st FDA Deputy Commissioner of Human Foods

23-Aug-2023 By Stephen Daniells

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).

FDA proposes relocation of Office of Dietary Supplement Programs, industry reacts

06-Jul-2023 By Asia Sherman

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...

ACI-CRN Legal, Regulatory and Compliance Forum: ‘The whiplash with everything going on this year can be a little disorienting'

05-Jul-2023 By Asia Sherman

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...

CRN: NDI guidance is 'doable'

24-Apr-2023 By Danielle Masterson

NutraIngredients-USA caught up with CRN’s Steve Mister at SupplySide East to discuss new research, top priorities for the year and what they hope to see from FDA this year.

Trades weigh in on call to clean up dietary supplement industry

31-Mar-2023 By Asia Sherman

In a recent letter to Congress, supplement company Ritual urged lawmakers to clean up a dietary supplement industry that has grown twenty-fold since the enactment of the Dietary Supplement Health and Education Act nearly 30 years ago.

Ullman breaks down FTC’s recent Health Products Compliance Guidance

22-Mar-2023 By Stephen Daniells

The details around claims substantiation in the recently released Health Products Compliance Guidance from the Federal Trade Commission (FTC) could be a “huge sea change”, says attorney Marc Ullman.

Bipartisan house bills reintroduced to regulate CBD in food, dietary supplements

20-Mar-2023 By Danielle Masterson

Does the legislation have legs or is it just for optics? Stakeholders agree the bills are a step in a positive direction, but what impact they will have, if any, is yet to be seen.

Proposed suit alleges Amazon selling “illegal drugs masquerading as therapeutic dietary supplements”

07-Feb-2023 By Danielle Masterson

Big name brands, “illegal drugs” and a formidable opponent to the supplement industry: it has all the underpinnings of a dramatic suit— but does it hold water?

Brands gear up to work with Congress on CBD pathway

06-Feb-2023 By Danielle Masterson

As CBD rulemaking languishes, businesses experience frustration and uncertainty.

Steve Mister on proposed FDA reorg, MPL, CBD, and CRN at 50

02-Feb-2023 By Stephen Daniells

The first month of 2023 is over, and already there’s some big developments (or non-developments in the case of CBD) for the US dietary supplements industry. We caught up with Steve Mister, president and CEO of the Council for Responsible Nutrition, to...

FDA heeds call for unified Human Foods Program under one leader as part of ‘transformative vision’ for food safety, nutrition oversight

31-Jan-2023 By Elizabeth Crawford

FDA this morning unveiled a “transformative vision” for a unified Human Foods Program that will bring together under one empowered deputy commissioner nearly all of its major food components that currently are scattered across multiple divisions to better...

Durbin seeks to add MPL provisions back into funding resolution

09-Dec-2022 By Hank Schultz

Senator Dick Durbin, D-IL, has called upon his colleagues to support the inclusion of Mandatory Product Listing language for dietary supplements into an omnibus funding bill that must be passed before mid December.

Colorado firm cited for plethora of disease claims

30-Nov-2022 By Hank Schultz

A warning letter issued to a Colorado-based supplement distributor points out the dangers of unguarded language used on supplemental websites.

NPA: Change in House could help make FDA more accountable

22-Nov-2022 By Hank Schultz

The change in House leadership could be an opportunity to hold federal agencies more accountable, says Daniel Fabricant, PhD, head of the Natural Products Association.

FDA warns seven companies over cardiovascular disease claims

18-Nov-2022 By Hank Schultz

Seven companies have been warned by the US Food and Drug Administration over claims of treating cardiovascular disease, the Agency announced yesterday.

DOJ prohibits Arizona company from distributing adulterated or misbranded supplements

31-Oct-2022 By Asia Sherman

A federal court has permanently barred Arizona-based Global Vitality Inc. from making and selling adulterated and misbranded dietary supplements after repeated violations over the last decade.

CBD entrepreneur Floyd Landis to share vision in upcoming NutraIngredients-USA webinar

10-Oct-2022 By Hank Schultz

Some CBD entrepreneurs talk a good game when it comes to their companies’ mission statements. Former pro cyclist Floyd Landis has lived his.

Durbin offers amendment to restore MPL to stopgap funding bill

29-Sep-2022 By Hank Schultz

Sen. Dick Durbin, D-IL, has offered an amendment to the stopgap federal government funding measure currently before Congress that would restore a Mandatory Product Listing requirement for dietary supplements.

Upcoming webinar to examine tumultuous CBD market

28-Sep-2022 By Hank Schultz

Demand for CBD ingredients remains high and innovation continues apace even as the regulatory uncertainty of the category persists. A panel of influential speakers will delve into these and other questions in an upcoming webinar hosted by NutraIngredients-USA.

Stopgap funding bill lacks any provisions specific to supplement industry

27-Sep-2022 By Hank Schultz

As had been expected, the final language of the stopgap measure to fund the federal government into December has no provisions relating to the dietary supplement industry.

CRN says FDA supplements resource goes too heavy on risk, too light on benefits

26-Sep-2022 By Hank Schultz

FDA’s new consumer facing information resource on dietary supplements places far too much emphasis on potential risks, the Council for Responsible Nutrition has commented.

MPL language appears destined to be stripped from final FDA fees bill

16-Sep-2022 By Hank Schultz

Preliminary indications are that the mandatory product listing language won’t be included in the final FDA fees reauthorization bill now making its way through Congress.

Amazon warning over skin tag products puts online giant on notice for assuring regulatory compliance

15-Sep-2022 By Hank Schultz

A recent warning letter to Amazon on the subject of skin tag removers was seen as significant for the dietary supplement industry because it puts the online sales giant on stricter notice for being responsible for the regulatory compliance of products...

AHPA’s updated Hemp Lexicon seeks to shed light on ‘full spectrum’ question

25-Aug-2022 By Hank Schultz

The American Herbal Products Association has released a new guidance document that seeks to bring clarity to hemp nomenclature, in particular what ought to be meant by the terms ‘broad spectrum’ and ‘full spectrum’ extracts.

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.

Califf memo warns of FDA furloughs if fees bill hangs fire

02-Aug-2022 By Hank Schultz

A failure on the part of Congress to pass an FDA fee reauthorization bill in a timely fashion could force furloughs among some Agency staff, according a memo from FDA Commissioner Robert Califf.

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.

DeLauro/Durbin bill to set up new, food-only federal agency finds broad support from supplement industry

26-Jul-2022 By Hank Schultz

A new federal agency aimed solely at food safety would be created by a bill introduced recently by US Rep Rosa DeLauro (D-CT) and Sen Dick Durbin (D-IL).

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.

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.

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.

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.

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,...

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.

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.

Paper highlights safety of some weight management ingredients

10-May-2022 By Danielle Masterson

With weight loss supplements under attack in several states, researchers rebut with science. The authors of a new paper examine the safety of six ingredients, a move they hope will encourage since-based decisions.

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.

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...