Regulatory

In 2010, OmniActive had obtained self-affirmed GRAS status for Lutemax 2020, and the new acknowledgement by FDA additionally underlines the ingredient’s safety.

While acknowledging that grapefruit can be part of a healthy diet, the agency does explain that grapefruit juice can interfere with the action of some prescription and nonprescription drugs.

The notification covers the ingredient at a dosage of up to 12 mg/day.

The facility manufactures flaxseed-based nutritional and functional ingredients for the food and beverage industry.

A major move boosts organic trade between the two territories.

In a December 2011 meeting, the NPF requested FTC action on 22 misleading advertisements.

Two members of Congress are calling on FDA to create arsenic and lead standards for juice products.

At the request of the European Commission, EFSA has established Population Reference Intakes for protein consumption.

Victory is back in the hands of the FTC after a judge ruled in November that Lane Labs did violate its consent decree.

Dan Fabricant, PhD, director of FDA’s division of dietary supplement programs, took audience questions about FDA’s new dietary ingredient (NDI) draft guidance during a December webcast. As expected, the most popular question asked was how long FDA expects it will take to finish reviewing the draft guidance comments it received. Fabricant’s answer? “How do you eat an elephant? One bite at a time.”

Industry urges FDA to take another stab at NDI draft guidance.

Members of the European Parliament said the legislation, as it is currently written, would not do enough to encourage healthier food formulations.

The company is again certified for GMPs under the Natural Products Association.

The author of a New England Journal of Medicine article says a premarket-approval system for supplements should be instated.

The program includes various presentations on scientific and regulatory affairs.

Derived from whole grain barley, Barliv is low in viscosity and invisible when added to foods and beverages.

Maca OSS and Cat’s Claw OSS have been kosher certified by Earth Kosher.

Two individuals and five related companies are implicated in the charges.

In December, FDA sent a warning letter to Nenningers Naturals LLC for making unauthorized drug claims about its Triple Flu Defense product-both online and during an industry trade show.

Previously, the ingredients were only available by prescription.

NSF scientists tested The Vitamin Shoppe’s True Athlete products for over 165 athletic banned substances.

The NSF Certified for Sport program minimizes the risks of banned substances in dietary supplement and sports nutrition products.

The company’s ARA already bears FDA GRAS affirmation in the United States.

One warning letter is a bad thing. But two warning letters?

The principle authors of DSHEA say that the draft guidance contradicts what they wrote in DSHEA.

Be careful when calling your product a “medical food”…or FDA might come knocking.

The initial June 2000 court order was the result of a consent decree reached with Lane Labs after the FTC charged the company with making unsupported and false claims.