Regulatory

Interested parties will now have until December 12, 2016 to submit comments on FDA’s revised new dietary ingredient (NDI) draft guidance-a 60-day extension over the previous deadline.

The seminar will cover a variety of recent regulatory changes for the dietary supplement industry in China, including the implementation of China’s new food safety law.

Rivkin Radler counsel will speak on issues ranging from FDA’s New NDI Draft Guidance to regulations for cannabis products.

Ayurvedic products must still comply with FDA and FTC regulations.

The announcement comes after snacks brand KIND submitted a citizen petition requesting FDA amend its definition of “healthy,” which was last updated more than 20 years ago.

If FDA can revoke the NDI status of vinpocetine as it considered doing this September, can it do the same to other ingredients, too?

DolCas Biotech says its BCM-95 turmeric extract is now self-affirmed GRAS in medical foods for doses up to 1000 mg per person per day.

FDA’s revised new dietary ingredient (NDI) draft guidance raises the specter of thousands of new NDI notifications. But which are most pressing?

As FDA looks to define the term "natural" on food labeling, industry leaders are split on what exactly the term should mean.

Nutritional Outlook interviewed the Global Organization for EPA and DHA Omega-3s to find out if conditions have improved at all for omega-3 firms under FDA's new NDI draft guidance document.

While some industry experts warn FDA is calling for tens of thousands of new NDI notifications, others anticipate the burden on industry will be more manageable.

GRAS consultants discuss criticisms of GRAS experts.

What does “Made in the USA” mean in a global age?

The announcement comes just a few months after LactoSpore received a “no questions” letter from FDA regarding its Generally Recognized as Safe (GRAS) submission.

Would an official, FDA-created grandfathered list help or hurt the industry?

Due to uncertainties over the NDI draft guidance, some wonder whether the popular GRAS system will still be a viable option for supplement manufacturers looking to exempt themselves from submitting NDI notifications to FDA.

The new finished product registry, developed by Underwriters Laboratory, will be known as the Supplement Online Wellness Library (Supplement OWL).

Questions still remain about how practical master files will be in practice.

The FTC alleges OMICS Group made false claims and failed to disclose steep publishing fees.

Common-use GRAS determinations are no longer common.

Some ingredient types, such as probiotics and synthetic botanicals, may have extra work on their hands as a result of FDA’s revised NDI draft guidance.

Regulators are increasingly scrutinizing product claims in the booming brain-health market.

How should the dietary supplements industry respond to FDA's new dietary ingredient (NDI) draft guidance, especially in a time of negative criticism?

At the recent Conference of Western Attorneys General, a panel on the nutritional supplement industry reportedly took on a more positive tone than similar panels conducted last year.

Australia’s regulatory approach to botanical ingredient changes may inform U.S. companies as they prepare NDI draft guidance comments.

What’s the best way to ensure a GRAS notification for an ingredient’s use in medical foods will receive a “No Questions” letter from FDA?

FDA is “absolutely within its rights” to request a separate NDI notification for ingredient combinations, says CRN’s Steve Mister, and the burden on industry could be minimal.

UNPA points out several provisions in the new NDI draft guidance that could hamstring industry innovation.