Regulatory

Recognizing the distinction between the two types of claims could have helped avoid the high number of “unnecessary” claims rejections.

Such claims include ones that EFSA at first judged as having insufficient supportive evidence and had requested submitters to provide more information.

According to Jarrow Formulas, for 90 of its 128 FOIA requests, FDA replied, “We searched our files and found no responsive information."

The agency has now posted a warning letter it sent in December to a company called Revolt Distribution Inc.

A product designed for inhalation cannot be considered a dietary supplement, FDA stated in a March warning letter to Breathable Foods Inc.

Attorneys from Amin Talati outline new dietary ingredients as they relate to the Food Safety Modernization Act.

The multimarketing company Amway is reportedly running a number of deceptive/unlawful marketing claims on powdered drink mixes.

The agency said current rules for phytosterol-fortified products remain effective until publication of a final rule.

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.

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA). It requires FDA to implement a sweeping array of new regulations and enforcement policies, intended to better ensure the safety of food products marketed in the United States, including dietary supplements.

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.