Regulatory

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of FDA’s division of dietary supplement programs, took audience questions about FDA’s new dietary ingredient (NDI) draft guidance during a December webcast. As expected, the most popular question asked was how long FDA expects it will take to finish reviewing the draft guidance comments it received.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Industry urges FDA to take another stab at NDI draft guidance.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.

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The principle authors of DSHEA say that the draft guidance contradicts what they wrote in DSHEA.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

Determining where the FTC is-or has been-heading in terms of the scientific substantiation required for health claims.

ISC has made great strides in implementing purity standards for the stevia industry.

The company’s environmental mission aims to preserve krill’s fragile ecosystem in the Antarctic.

GOED, the Global Organization for EPA and DHA Omega-3s, is omega-3’s advocate.

For cardiovascular health claims, EFSA’s NDA Panel seemed to embrace most of the generally accepted biomarkers. For antioxidant claims, EFSA stressed that physiological effects should be demonstrated in vivo.

EHPM said that with a shelf life of up to three years for most supplement products, the short length of time for transition would result in significant costs for SMEs.

The working group will assess the NRVs for 28 nutrients-some already existing in the Codex Guideline, and others for potential addition.

AHPA is urging that no FSMA-associated fees be imposed on small business until FDA publishes guidance outlining the burden of such fees on small businesses.

FDA says that $70,000 and 4000 lb worth of raw materials were seized.

An ingredient supplier who bought the corn “unwittingly sold the falsely labeled corn to its customers as certified organic corn, who used the mislabeled corn to produce their organic products."

In a joint statement, associations urge focus on their united message, rather than on looking for points of disparity between individual guidance comments.