Regulatory

A new generation of natural colors is having to jump stability hurdles relating to temperature, acidity, and co-formulated ingredients. How are suppliers adapting?

Will the wrong trial design make your dietary supplement or functional food an unregistered drug?

The Food and Drug Administration (FDA) must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN).

Jungbunzlauer has recently started producing pure L(+)-lactic acid, sodium lactate, and potassium lactate by traditional fermentation of natural, non-GM carbohydrates.

The company says that AstraGin has been demonstrated in vitro, in vivo, and in humans to significantly promote and improve absorption of amino acids, glucose, and vitamins.

The company has received the AIB International (American Institute of Baking) highest rating of "superior" for the 8th straight year.

The company has petitioned FDA for a qualified health claim for whole grains and certain food products containing whole grains.

“More and more, consumers are using the Natural Seal to find natural products at their favorite stores," says NPA president Jeff Wright.

The Argentine National Administration of Drugs, Foods and Medical Devices’ (ANMAT) newly introduced guidelines on the assessment of health claims in food advertising is an example of a growing trend towards the regulation of health claims in Latin America, an EAS adviser has said.

The list no longer includes Canadian operations, which thanks to a recent U.S.-Canada partnership means those companies no longer need to maintain certification according to USDA organic standards in order to sell organic products in the United States.

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.