Regulatory

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The principle authors of DSHEA say that the draft guidance contradicts what they wrote in DSHEA.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

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.

NPA says it will work to ensure the agency does not allow the high-profile issues fall through the cracks.

The two associations today submitted their comments on the NDI draft guidance to FDA, whose comment deadline is today.

The complaint says EFSA is using the same type of stringent assessment for both Article 13 and 14 claims, which may have unfairly resulted in the high number of rejected Article 13.1 claims.

EFSA is making public previously unpublished scientific data, including 112 original studies on aspartame that were submitted during a request for aspartame authorization in Europe in the early 1980s.

On the eve of tomorrow’s close of the new dietary ingredient (NDI) draft guidance comment period, Nutritional Outlook is keeping updated on comments submitted.

The latest batch of notifications included those for novel herbal preparations, new chemically combined vitamin-mineral ingredients, and cutting-edge enzymes.

Currently, the report says, FDA targets adulteration on a broad and overall scale and does not necessarily distinguish between factors that may inspire adulteration.

Food companies have five years to comply with new, mandatory nutrition labeling rules in the EU, says regulatory consultant EAS.

Jarrow Formulas is calling out FDA for failing to adequately respond to a Freedom of Information Act (FOIA) request the supplements brand sent the agency in September.

The agency also notes it’s the first time it has taken legal action against a dietary supplement manufacturer of this size for failing to comply with dietary supplement current Good Manufacturing Practices.

Recommended intake for bioactive food components should be based on the totality of the evidence, IADSA has stated.

EHPM has urged the European Commission not to automatically consider claims that have received negative opinions from EFSA as rejected.

As reasoning, the bill states that dietary supplements have had “an exemplary public health safety record” over the years.

In a move sure to shake up the global sweetening industry, steviol glycosides have been approved for use in foods sold in the European Union.