Regulatory

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Due to uncertainties over the NDI draft guidance, some wonder whether the popular GRAS system will still be a viable option for supplement manufacturers looking to exempt themselves from submitting NDI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types, such as probiotics and synthetic botanicals, may have extra work on their hands as a result of FDA’s revised NDI draft guidance.

How should the dietary supplements industry respond to FDA's new dietary ingredient (NDI) draft guidance, especially in a time of negative criticism?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Australia’s regulatory approach to botanical ingredient changes may inform U.S. companies as they prepare NDI draft guidance comments.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UNPA points out several provisions in the new NDI draft guidance that could hamstring industry innovation.

From maximum vitamin and mineral levels to the future of EFSA, speakers at the recent “Brexit Impact” webinar hosted by AHPA and CRN explain what companies should watch out for.

AHA recommends children aged 2–18 consume no more than six teaspoons of added sugars per day and limit consumption of sugary drinks to less than 8 ounces per week.

“To battle pointlessly only gives the industry’s critics further ammunition that we oppose any effort to rein in the bad actors that lurk around the fringes of the industry,” says CRN’s Steve Mister.

Plus: Will FDA now step up its game of NDI enforcement?

Industry should remain on high alert over whether FDA's "chemical alteration" language in its revised new dietary ingredient draft guidance will require a broad swath of industry companies to submit NDI notifications, expert says.

The second generation of USP’s Food Fraud Database includes added capabilities that make it easier for users to identify historical trends and vulnerabilities for food fraud.

The warnings span everything from products for hangover relief to picamilon-containing dietary supplements.

Just one day after FDA finally issued its revised new dietary ingredient (NDI) draft guidance for dietary supplements, the agency today released its Generally Recognized as Safe (GRAS) final rule for food ingredients.

FDA today released its long-awaited revised new dietary ingredient (NDI) draft guidance with two major changes the dietary supplement industry will likely hail as good news.

The USDA now has two years to hammer out details for implementing the federal GMO-disclosure law.

The Natural Products Association has launched a new database of more than 400 dietary supplement warning letters from FDA, as well as other regulatory enforcement actions taken since 2008.

From cat scans to particle structure, ingredient suppliers are using advanced methods to help food formulators cut sodium.

Fiber suppliers at this year’s Institute of Food Technologists Annual Meeting & Food Expo told Nutritional Outlook that while they are confident FDA will eventually consider their ingredients to be dietary fibers, the path to FDA approval is unclear.