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HSA, FSA for supplements: ‘We are about to get the legislation introduced,’ says CRN’s Mister

05-Jul-2023 By Stephen Daniells

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.

CRN’s citizen petition makes case for dietary supplements, drugs to coexist

11-May-2023 By Danielle Masterson

“This is about certainty for supplement companies and access and certainty for consumers.”

FDA launches directory of ingredients used in products marketed as supplements

07-Mar-2023 By Stephen Daniells

The US Food and Drug Administration (FDA) has unveiled a new Dietary Supplement Ingredient Directory, providing detailed information on 27 ingredients that the Agency states are used in products marketed as dietary supplements.

Guest Article: NPA Chief on 2022’s industry sagas and what these mean for 2023

20-Dec-2022 By Daniel Fabricant, PhD. President & CEO, the Natural Products Association (NPA)

As social creatures were often reluctant to pick sides. It feels personal that we’re picking one person or group of people over another. However, for our industry, the reality is that there are divisive issues.

NPA withdraws FDA lawsuit following final NAC guidance, marketplace stabilization

02-Nov-2022 By Stephen Daniells

The Natural Products Association has dismissed its case against the US Food & Drug Administration following the Agency’s issuance of a final guidance for N-Acetyl Cysteine (NAC).

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.

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.

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...

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.

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.

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.

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...

CRN’s Mister on NAC: ‘This isn’t a one ingredient issue’

14-Mar-2022 By Stephen Daniells

As the uncertainty around the regulatory status of NAC (N-acetyl cysteine) continues, it is important the industry doesn’t lose this for the precedent it sets for other potential ingredients, said CRN’s Steve Mister.

Trade organizations welcome Califf appointment as FDA commissioner

15-Feb-2022 By Stephen Daniells

Dr Robert Califf has been confirmed as the new commissioner of the Food & Drug Administration in a tight 50-46 vote in the US Senate.

Trade groups dial up pressure on FDA for resolution on NAC issue

27-Jan-2022 By Hank Schultz

Trade organizations have filed documentation with the US Food and Drug Administration bolstering their assertion that the Agency acted arbitrarily and illegally when it ruled that NAC is not a legal dietary ingredient.

CRN says FDA dodging central legal issue in its stance on NAC

06-Jan-2022 By Hank Schultz

The Council for Responsible Nutrition has turned up the heat on FDA over its position that NAC is not a legal dietary ingredient. CRN asserts that the Agency has ignored a central legal question.

NutraIngredients-USA’s Top 10 most read articles of 2021

23-Dec-2021 By Stephen Daniells

As the year draws to a close, we thought it would be worthwhile to review the most read articles, with NAC, FDA kratom seizures, vitamin D benefits, and Elysium Health making the top 10.

NPA sues FDA over NAC: ‘We’ve been left with no choice,’ says Fabricant

07-Dec-2021 By Stephen Daniells

The Natural Products Association (NPA) has filed a lawsuit in the US District Court for the District of Maryland requesting the Food and Drug Administration cease its “unlawful retroactive application of the Food, Drug, and Cosmetic Act” against N-acetyl-L-cysteine...

‘FDA kicked the can’: NPA & CRN slam Agency’s ‘tentative’ responses to NAC Citizen Petitions

24-Nov-2021 By Stephen Daniells

The Council for Responsible Nutrition and the Natural Products Association have slammed the Food and Drug Administration (FDA) for delaying a decision on the regulatory status of NAC (N-acetyl-L-cysteine) in dietary supplements, as the Agency issues ‘tentative...

CRN on mandatory product listing: ‘We’re making some real progress on the negotiations’

02-Nov-2021 By Stephen Daniells

Draft bills circulating around Congress to codify mandatory product listings for dietary supplements are progressing, and could be introduced soon, says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

Lawmaker’s letter to FDA demands clarity on NAC issue

29-Oct-2021 By Hank Schultz

Rep. Jeff Duncan, R-SC, sent a strongly worded letter to FDA yesterday requesting clarity on the matter of NAC, NDI enforcement and other matters.

Expanding FDA's tool box, fending off state laws among priorities laid out at CRN meeting

21-Oct-2021 By Hank Schultz

CRN president and CEO Steve Mister laid out four priorities for the supplement industry at a meeting yesterday. Among the highlights were to prepare for state based regulations and strengthening self regulation.

NPA files petition asking FDA to rule NAC as legal ingredient

19-Aug-2021 By Hank Schultz

The Natural Products Association has filed a citizen’s petition asking FDA to acknowledge NAC as a legal dietary ingredient. The molecule, which has been on the market for decades, was ruled last year as violative by the Agency.

CRN's petition sets 180-day deadline for resolution of NAC issue

02-Jun-2021 By Hank Schultz

The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning...

CRN: ‘This is not the final word on NAC’

11-May-2021 By Stephen Daniells

While Amazon moves ahead with removing NAC-containing dietary supplements from its website, the FDA’s Office of Dietary Supplement Programs (ODSP) acknowledges that it is still reviewing the information around the ingredient.

NutraCast Podcast: Attorney Durkin on the 'Race to Market'

11-Dec-2020 By Danielle Masterson

Attorney Bob Durkin said that he regularly comes across clients who are curious about the prospects of studying an ingredient for use in both food and drugs.