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Legal and Regulatory updates for the food and supplement industry

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FDA Requests Comments on Appropriate RACCs for Flavored Nut Butter Spreads

Posted on November 3, 2016

Following on the recent issuance of a final rule updating reference amounts customarily consumed (RACCs) for various foods, FDA has issued a Request for Information (RFI) on the appropriate RACCs …
Continue Reading FDA Requests Comments on Appropriate RACCs for Flavored Nut Butter Spreads

FSMA Update: FDA Releases FSMA Preventive Controls Guidance for Small Businesses

Posted on November 2, 2016

FDA has released small entity compliance guidances under the Food Safety Modernization Act (FSMA) to support the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal …
Continue Reading FSMA Update: FDA Releases FSMA Preventive Controls Guidance for Small Businesses

FSMA Update: FDA Issues Draft Guidance Regarding Suppliers’ Disclosure of Uncontrolled Hazards in Foods

Posted on October 31, 2016

FDA has released draft guidance for industry regarding suppliers’ disclosure of uncontrolled hazards in foods as required by four rules implementing the Food Safety Modernization Act (FSMA).

  • As previously

…
Continue Reading FSMA Update: FDA Issues Draft Guidance Regarding Suppliers’ Disclosure of Uncontrolled Hazards in Foods

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 Provides Status Report on Recall Rapid-Response Team Activities

Posted on October 26, 2016
  • In April 2016, the Food and Drug Administration established a team of Agency leaders to oversee challenging recalls and to help overcome obstacles and streamline the recall process. Shortly after

…
Continue Reading FDA Provides Status Report on Recall Rapid-Response Team Activities

FSMA Compliance – What to Expect in the Next Few Months

Posted on October 14, 2016

FDA has released a Q&A document regarding the Agency’s expectations going forward for FSMA compliance now that the first set of major FSMA compliance dates have arrived. 

  • The first major

…
Continue Reading FSMA Compliance – What to Expect in the Next Few Months

Extension to Vinpocetine Comment Period Requested

Posted on October 13, 2016

 The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017.

  • Vinpocetine is a semisynthetic derivative of the

…
Continue Reading Extension to Vinpocetine Comment Period Requested

Tracking Compliance Dates for FDA Nutrition Initiatives

Posted on October 11, 2016

The U.S. Food and Drug Administration (FDA) has received a number of questions on the timing of compliance dates for its nutrition initiatives. In response, the Agency published a reminder…
Continue Reading Tracking Compliance Dates for FDA Nutrition Initiatives

FDA Issues Updated MFRPS

Posted on October 6, 2016

FDA has issued an updated Manufactured Food Regulatory Program Standards (MFRPS) for state regulatory programs that oversee food facilities.

  • Since May 2007, FDA has issued regulatory program standards, known as

…
Continue Reading FDA Issues Updated MFRPS

Fruit Labeling Accuracy Act of 2016 Would Prohibit Added Sugars Labeling for Naturally Tart Fruits

Posted on September 29, 2016
  • As reported on May 20, 2016 on this blog, the Food and Drug Administration (FDA) issued final rules to implement changes to nutrition labeling requirement in the U.S. In

…
Continue Reading Fruit Labeling Accuracy Act of 2016 Would Prohibit Added Sugars Labeling for Naturally Tart Fruits

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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