February 6, 2019

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Nutrient Database Release 28 moving to “FoodCentral Data” in 2019

The backbone of the FDA’s Nutrition Facts boxes is a Nutrient Database Release 28 managed by USDA. USDA is moving the database and search tool to a new URL: FoodCentral Data.  Many in regulatory affairs have downloaded excel versions of the nutrient values for various reports and now you’ll want to monitor this migration.  USDA promises to merge available information to a centralized access point.  The nutrient values and food composition information is to be housed more centrally to support nutrition and health policy efforts.

USDA posted on their website for the Food Composition Databases

As a result of the recent government furlough, the date that USDA’s food composition databases will no longer be available on this site has been changed to the second quarter, 2019. All of these datasets, including the Food and Nutrient Database for Dietary Studies (FNDDS), SR Legacy, and the USDA Branded Food Products Database, will transition to FoodData Central, a new and harmonized USDA food and nutrient data system. FoodData Central will also include expanded nutrient content information never before available as well as links to diverse data sources that offer related agricultural, food, health, dietary supplement, and other information. Check back often to this page for updates on the transition to FoodData Central.

This database integrates government standard reference foods with brand-name product nutrient values. So user beware–not all the “branded product” information is that reliable.  The database is the core of nutrient values for the leading “for-profit” software tools used to create Nutrition Facts labels (panels). This data formerly populated the USDA Choose MyPlate nutrient analyses tool. It provided thousands of users free access to nutrient analyses of one’s personal data until the current administration discontinued access June 2018. (The Agency reasoned that users could get the same information elsewhere–but they failed to acknowledge that it would be a fee.)

January 30, 2019

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Two-sides to dairy-identity labeling

The Daily Intake presents two sides of the dairy “identity crisis”.  Keller and Heckman LLP’s Daily Intake features a few of the 13,000+ comments posted on what a “milk” should be as FDA’s comment period closed January 28, 2019.  Comments were submitted to FDA for what products may be called “milk, cheese, and yogurt” and if those plant-based cousins could equally use the names on the statements of identity.  The blog balanced the “for” and “opposed” examples here.

Consumers and industry members will now have to wait for FDA to reveal its decision….and it could be some weeks given the recent government shutdown.  FDA could retain the standards (government definitions of what qualifies as “lacteal secretions”), propose new standards (with proposed new regulated categories), or do nothing.

January 9, 2019

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Can’t Fool Mother Nature–testing for organic sources

Technology Networks reports on a method to detect organic and non-organic sources of milk. They summarize a paper in the Journal of Agricultural and Food Chemistry exploring ratios of carbon isotopes in a small sample of milk products.  This would be a new application of technology to help fight fraud.

In this application, researchers would look for ratios of carbon isotopes that vary based on the plant materials fed to the cows.  The typical diet of cows fed organic feed is different than conventionally fed cows.  This translates into different carbon isotopes in the fatty acids of the milk. The researchers looked for similar effects in the amino acids between organic and conventional milks.

As these methods are validated and tested in other foods, it brings new meaning to “trust but verify” and “it is not nice to fool Mother Nature”.

Ill-Min Chung, et al. “Fatty Acid- and Amino Acid-Specific Isotope Analysis for Accurate Authentication and Traceability in Organic Milk.” J. Agric. Food Chem. Article ASAP. Publication Date (Web): December 13, 2018. DOI: 10.1021/acs.jafc.8b05063.


December 20, 2018

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GMO labeling & Bioengineered (BE) labeling disclosures released by USDA

JUST RELEASED: The FINAL requirement to label USA foods and supplements with bioengineered (BE) content was announced today.  Labeling products–including imports–with BE content is the government language for declaring “GMO content” by January 1, 2022. The USDA is the regulatory agency and the rules apply to select USDA and FDA-regulated foods and supplements.

This does NOT apply to products CERTIFIED as organic.  These products already must not contain ingredients altered by biotechnology.

Simplistically, the “GMO content” must be declared based on SELECT crops, the DETECTABLE amount of genetic material, AND the biotechnology used to alter the crops.

Knowledge Bank will provide more information but here is the USDA link.

December 18, 2018

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Congress says skip the “added sugars” on honey and maple syrup

Congress put a stop to misleading “added sugars” declarations on honey and maple syrup nutrition facts labels with the passing of the Farm Bill.  A product packaged as solely “sugar”, honey, or a syrup (like maple syrup or agave syrup) shall not be required to show a value for “added sugars”.  This overrides the FDA’s 2016 regulatory update and guidance language that mandated a value because these foods are used in consumer diets as a source of “added sugars”.  Industry consistently objected to this as consumers understood it meant that MORE cane or beet sugars were being added to Mother Nature’s honey and maple syrup creations.

The simple paragraph within the 2018 Farm Bill is easily missed with the heading: SEC. 12516. LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS.

IMPORTANTLY: Processed foods that include these sweet ingredients WILL BE REQUIRED to show “added sugars”. This declaration and the paper trail to show how the value was derived remain a part of the 2016 regulatory update.  The deadline for most companies to comply with the new Nutrition Facts format is barely 1 year away.

Special thank you to Riëtte van Laack of Hyman, Phelps & McNamara PC for putting this joy in today’s reading.

December 12, 2018

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“NOT-so-whole” -“whole grain” crackers face new court action

The Daily Intake by Keller and Heckman LLP summarize Kellogg Co.’s latest label troubles with “whole-grain” CHEEZ-IT crackers.  Plaintiffs brought the original lawsuit because “whole grains” were not the first  or even second ingredients in the snacks.  The case was dismissed in 2017 but resurfaced following the court appeals process.

How the appeal’s court views the label content vs the original judge’s view is a reminder of the “luck of the draw” and “just cause your neighbor is doing it….it may not be in your favor.”

Read about the comments on Keller and Heckman’s site

November 19, 2018

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Pacing the halls for details of Bioengineered labeling requirements

Join those who are anxiously pacing the halls because USDA proposed “bioengineered food” or “BE” term could replace “GMO”.  Timing of this “BE” labeling disclosure (requirements) will coincide with the FDA’s compliance date for nutrition facts and supplement facts changes.

December 1, 2018 looms as one of several major announcements for labeling rules in both the food and supplement industries.  That date marks the expected announcement of the USDA’s decision for how and what to label genetically engineered content of foods (and supplements).  This becomes the federal requirement to disclose “GMO” content on a majority of American foods, including those imported to the USA.  It was signed in 2016 as a replacement for the state-by-state requirements (like Vermont’s GMO law).

Watch the federal review progress at the Office of Management & Budget’s dashboard.



November 7, 2018

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A little help from our Agency friends

FDA published 2 more guidance documents to help companies update their Nutrition Facts (and Supplement Facts) labels. The Agency provided more details about “added sugars” from fruit & vegetable materials as well as clarity in what is a “single serving” container with and without dual column displays.

Additionally, FDA confirmed the date companies are working toward is the date the label is applied to the product.  The labels compliant to the May 2016 regulatory updates must be applied to retail packaged foods on January 1, 2020 (or 2021 if under $10million in sales). That means there will be many years for the marketplace to be a mix of the “old” and “new” Nutrition Facts and Supplement Facts labels.

[…and, yes, the FDA has moved away from calling these “NFP” and “SFP”. These are no longer “panels” but “labels”.]

Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals
Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics


October 29, 2018

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FDA requests information on sesame as allergen in USA

FDA issues a press release to request information (RFI) on sesame as an allergen for USA consumers. The Agency seeks data and incidences of sesame allergens as the USA does not currently require disclosure of sesame as one of the 8 major USA allergens.  (In other countries, sesame is a required allergen declaration.)

Manufacturers should not change their allergen declarations (i.e., “Contains:” statement) until FDA formally makes a new rule.

The comment period opens October 30, 2018 and will remain open for 60 days.

All submissions received must include the Docket No. FDA-2018-N-3809.

Comments and information can be submitted to

To submit electronic comments, go to https://www.regulations.gov and search for Docket No. FDA-2018-N-3809.

Written comments must be sent to:

Docket Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

October 22, 2018

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Cultured cells as “meat & poultry” discussed by FDA & USDA/FSIS

Check those holiday menus–those traditional menu items may not be what you think in the future!

What is “meat” and “poultry”?  Join FDA and USDA/FSIS for a free 2-day webinar on cell-cultured meat and poultry.

October 23-24, 2018

The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies. The second day of the meeting will focus on labeling considerations.

Representatives of industry, consumer groups and other stakeholders are invited to participate in the meeting. Attendees are encouraged to pre-register to attend the meeting. Pre-registration is available at the Meetings and Events page on the FSIS website.

Webinar and meetings will be held on Oct. 23 from 8:30 a.m. to 4 p.m. (EAST COAST), and Oct. 24 from 8:30 a.m. to 3 p.m. (EAST COAST) in the Jefferson Auditorium in the U.S. Department of Agriculture South Building, 1400 Independence Ave. SW, Washington, DC, 20250.

First day webinar link