FDA seeks Comments on Draft Guidance for Food Industry, declaration of the name "potassium chloride salt" instead of "potassium chloride" in food labels.

FDA seeks draft  guidance on to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name "potassium chloride salt" in the ingredient statement on food labels as an alternative to the common or usual name "potassium chloride."
Follow the links to submit your choice.

Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling

Submit Comments by 07/19/2019

Submit Comments Online

https://www.regulations.gov/docket?D=FDA-2019-D-0892

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305) 
Food and Drug Administration 
5630 Fishers Lane, Rm. 1061 
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-0892

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Docket Number:

FDA-2019-D-0892

Issued by:

Office of Nutrition and Food Labeling

The purpose of this draft guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name "potassium chloride salt" in the ingredient statement on food labels as an alternative to the common or usual name "potassium chloride."

FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling their food products, including those that are formulated to reduce sodium content. This enforcement discretion may result in manufacturers using potassium chloride as a substitute ingredient for sodium chloride and lead to increased consumer understanding of the use of potassium chloride as a replacement for sodium chloride (i.e., salt).

This draft guidance is consistent with FDA's Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options. This draft guidance is also consistent with FDA's previous activities to encourage manufacturers to reduce the sodium levels in food products in the interest of public health.

FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance

https://www.fda.gov/media/125081/download

Hundreds of thousands of incidents related to breast implants had been kept out of public sight may be revealed under new "Program"

Records of millions of cases of patient harm and product malfunctions previously kept hidden from the public could soon be released following a major policy change by the key United States regulator.

In a major advance for medical device transparency, the U. S. Food and Drug Administration has pledged to disclose information kept buried for nearly two decades under a program known as “alternative summary reporting.”
FDA Commissioner Scott Gottlieb announced the policy change on Twitter two days after the International Consortium of Investigative Journalists reported that hundreds of thousands of incidents related to breast implants had been kept out of public sight under the summary reporting program.
A March 7 report by Kaiser Health News revealed that more than 1.1 million incidents since 2016 had been kept from public view because of summary reporting.

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.
Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.
“I don’t want to sound over dramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

Via ICIJ