Fda - Food

NutraCast: How amendments in the 2023 Farm Bill could shape the hemp industry

13-Oct-2022 By Danielle Masterson

Over the course of the next year, lawmakers on the US House and Senate agriculture committees will draft a new federal Farm Bill that will shape a number of programs for the next five years. What does that mean for the hemp industry?

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.

Three for three: Hofseth Biocare gets NDI nod from FDA for bioactive peptides

29-Aug-2022 By Stephen Daniells

Hofseth BioCare (HBC) has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its ProGo bioactive peptides, having already achieved this for its CalGo and OmeGo ingredients.

NAC supplements back on Amazon

25-Aug-2022 By Stephen Daniells

After a hiatus of over a year, Amazon is again selling NAC-containing dietary supplement products. The development was described as exciting by one industry trade association.

Warning letter alleges company used raw materials tainted with glass and plastic

24-Aug-2022 By Hank Schultz

An FDA warning letter sent to supplement manufacturer Oregon’s Wild Harvest said the company failed to demonstrate that it had a valid method for assuring that incoming raw material lots were free of contaminants.

Provisions of Senate bill could decimate hemp industry, industry group asserts

10-Aug-2022 By Hank Schultz

Legislation currently in the Senate could burden the hemp industry by setting an unrealistically low level of allowable THC, an industry group has said.

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.

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...

NAC: New FDA guidance confirms Agency exploring potential of rulemaking

01-Aug-2022 By Stephen Daniells

The FDA appears to be moving ahead with a proposed rule to allow NAC (N-acetyl cysteine) as a dietary ingredient for use in supplements, according to a newly published guidance.

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.

Top 8 takeaways from Regulatory Summit

26-Jul-2022 By Danielle Masterson

This year’s Dietary Supplement Regulatory Summit in Washington, DC, featured updates and insights from top FDA officials, including the Office of Dietary Supplement Programs along with top stakeholders and industry experts. Here are a few key takeaways...

Guest Article

CRN says furor about new prohibited act is much ado about nothing

25-Jul-2022 By Miriam Guggenheim, Partner, Covington & Burling and Steve Mister, President CEO, Council for Responsible Nutrition

Much has been made in recent weeks about the Senate HELP committee’s inclusion in the FDA user fee legislation of a new prohibited act related to dietary supplements. We think this handwringing is sorely misplaced and is creating a false flag to justify...

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.

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.

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.

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...

Part 1

FDA’s Cara Welch on RRAs & third-party audits: 'We’re staring at a backlog of inspections'

27-Jun-2022 By Stephen Daniells

The head of the FDA’s Office of Dietary Supplement Programs suspects that remote regulatory assessments (RRAs) will continue even as regular facility inspections resume post-COVID, as the agency seeks to get a good picture of the compliance status of...

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.

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).

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.

IPAWC + Probiota Americas 2022: Regulators, start-ups & investment headline Day 3

26-May-2022 By Stephen Daniells

The return of the IPA World Congress + Probiota Americas is just over a week away. Don’t wait to register your attendance for this world-class program in Washington, D.C.

FDA announces enforcement discretion, amnesty window on missing NDI filings

19-May-2022 By Hank Schultz

FDA announced today that intends to exercise enforcement discretion on missing New Dietary Ingredient Notifications. The Agency also set up a new portal to allow companies to more easily come into compliance by filing the notifications that they should...

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 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...

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.

'Not matched by other conferences': 7 reasons to attend the IPA World Congress + Probiota Americas 2022

28-Apr-2022 By Stephen Daniells

The IPA World Congress + Probiota Americas 2022 is just over a month away! The leading event for the probiotics, prebiotics, and microbiome community is a must-attend event, and let us tell you why…

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...

CBD list chaos continues as FSA extends deadline to allow more companies to seek approval

22-Apr-2022 By Liza Laws

The deadline for companies wanting to submit its CBD products to be approved for sale has been extended by the Food Standards Agency (FSA).

FDA formally announces NAC enforcement discretion, but legal hangover remains

21-Apr-2022 By Hank Schultz

The US Food and Drug Administration declared today that it will exercise enforcement discretion on the use of NAC. It also said that it is ‘likely’ to make a rule that would formalize the legal use of the compound in finished dietary supplements.

NutraWomen Wednesday: Pooja Nair, partner at Ervin Cohen & Jessup LLP

20-Apr-2022 By Danielle Masterson

Attorney Pooja Nair is a Harvard-educated business litigator who has an eagle eye on the food and beverage sector. She advises clients, including restaurant groups, food brands, and manufacturers on a comprehensive range of issues. She is also a noted...

FDA vets claim DSHEA gives Agency plenty of authority, some of it little used

18-Apr-2022 By Hank Schultz

Three former FDA officials said powers granted to the Agency under DSHEA should be fully implemented before modifications of the fundamental regulation of the dietary supplement industry should be considered.

FDA signals it won’t go after NAC, but legal issues remain unresolved

01-Apr-2022 By Hank Schultz

According to an FDA communique issued yesterday marketers of NAC products mostly likely can continue to business as they have without receiving warning letters or having products seized. But observers say the legal issues raised by the affair are far...

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