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Legal and Regulatory updates for the food and supplement industry

GUIDANCE

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Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns

Posted on January 17, 2017

As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received…
Continue Reading Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns

FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

Posted on December 8, 2016
  • As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to

…
Continue Reading FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

Menu Labeling Update

Posted on November 30, 2016
  • As previously covered on this blog, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable

…
Continue Reading Menu Labeling Update

Scaling Back Sodium: GMA Comments on Short-term Sodium Reduction Guidelines

Posted on October 27, 2016

The Grocery Manufacturers of America (GMA) has requested that the short-term sodium reduction goals be extended to at least four years, and that FDA account for differing functional roles of …
Continue Reading Scaling Back Sodium: GMA Comments on Short-term Sodium Reduction Guidelines

FDA Updates Food Facility Registration Product Categories

Posted on September 28, 2016

FDA has issued guidance updating the food product categories that companies can select when registering as a food facility with the agency.

  • Under Section 415 of the Federal Food, Drug,

…
Continue Reading FDA Updates Food Facility Registration Product Categories

FDA Issues Guidance for the Labeling of Infant Formula

Posted on September 19, 2016

On the heels of recently released draft guidance concerning substantiation for infant formula structure/function claims, FDA has issued guidance regarding the labeling of infant formula.

  • Infant formula is clearly receiving

…
Continue Reading FDA Issues Guidance for the Labeling of Infant Formula

Scaling Back Sodium – FDA Extends Comments Period for Draft Guidance

Posted on August 22, 2016

FDA has extended the comments period for its draft guidance regarding sodium reduction in food.

  • As previously covered on this blog, on June 1, 2016, FDA issued a draft

…
Continue Reading Scaling Back Sodium – FDA Extends Comments Period for Draft Guidance

Supplement Spotlight: FDA Revises NDI Draft Guidance

Posted on August 11, 2016

FDA issues long-awaited revised Draft Guidance on new dietary ingredient notifications (NDINs) for dietary supplements.

  • The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a

…
Continue Reading Supplement Spotlight: FDA Revises NDI Draft Guidance

FDA Guidance: Nutrients in Small Amounts

Posted on July 8, 2016

FDA finalizes guidance on declaration of small amounts of nutrients and dietary ingredients on nutrition labels.

  • In August 2015, FDA issued a draft guidance document stating the Agency’s policy on

…
Continue Reading FDA Guidance: Nutrients in Small Amounts

FDA Guidance: Prior Notice

Posted on June 16, 2016

FDA issues third edition of guidance regarding prior notice for imported food.

  • Under Section 801(m) of the Federal Food, Drug, and Cosmetic Act, FDA requires the submission of “prior notice”

…
Continue Reading FDA Guidance: Prior Notice

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