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

 

October 3, 2018

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Plant-based dairy food names & perceptions sought by FDA

Updating and understanding the names of plant-based dairy food alternatives continues FDA’s effort to modernize regulations.  FDA is gathering information on what it could use to regulate the names “soy milk”, “almond ice cream”, or “vegan mozzarella cheese”.

FDA posted a request for comments, surveys and data related to how consumers view and use alternatives to cow’s milk and related products.   The Federal Register announcement and accompanying press release demonstrate FDA’s concern about the nutrient differences between animal- and plant-based products.

The primary health concerns are based in potential nutrient deficiencies children may experience if dairy food alternatives are low or lacking key vitamins, minerals or essential amino acids. The FDA expressed concern that the USDA national database of food composition tables may be limited in characterizing the real world offerings of plant-based milks, yogurts and cheeses.

The FDA has 5 broad areas for information gathering. Consumer selection of dairy alternatives for “sustainability” and “animal husbandry” are not specifically called out. Rather, these concepts would fall under the broader umbrella of consumers choosing dairy alternatives for lifestyle reasons.

Federal Register text posted here

Comments accepted until 11/27/2018 for Docket No. FDA-2018-N-3522   https://www.regulations.gov

 

 

September 5, 2018

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Nominations open to 2020-25 Dietary Guidelines Advisory Committee

Professionals are sought for federal committee to shape food and nutrition policies. USDA and the Department of Health & Human Services are seeking nominations for the committee developing the 2020-25 Dietary Guidelines for Americans.  This committee is expected to start Fall 2018/Winter2019 and meet 5 times.  Its duties will be to establish more of a framework for federal nutrition programs, particularly the nutrient needs for pregnant women and children from birth to 24 months.

The role is an independent, science-based advisory role.  Historically the committee has had challenges finding industry-experienced experts.

Applications Due By: October 6, 2018

Pre-publication details announced in Federal Register. http://s3.amazonaws.com/public-inspection.federalregister.gov/2018-19302.pdf

Additional information about the Committee is available at
http://www.dietaryguidelines.gov

The September 5, 2018 USDA Press Release, titled “Nominations now open for the 2020 Dietary Guidelines Advisory Committee”, is posted at
http://www.usda.gov/media/press-releases/2018/09/05/nominations-now-open-2020-dietary-guidelines-advisory-committee

 

July 17, 2018

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Don’t slip up! FDA Warning Letter Scam

The FDA recently posted FDA warns of imposters sending consumers fake warning letters.  “While warning letters are a common compliance tool used by the FDA, we typically send them directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products,” said FDA Commissioner Scott Gottlieb, M.D. “Consumers who aren’t involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it’s probably fake, and probably a scam.” Full Posting

Remember – Warning letters are given to manufactures, distributors and others who are part of the supply chain for the manufacture and sale of FDA regulated products – Foods, Dietary Supplements, Medical Devices, Drugs, Vaccines and Biologics.

Current warning letters (2013 to present day) are published on the FDA’s website.  Older warning letters (2005-2012) have been archived and are no longer available or searchable on the FDA’s website. Knowledge Bank has made archived warning letters available and searchable from the Google search bar at www.fdalabelcompliance.com.

 

 

June 15, 2018

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The FDA Approved Dietary Fiber list gets fatter with 8 new additions.

Sorry for the pun, but sometimes you just need to make a dry fibrous topic a little more fun and chewy…

The FDA added 8 new dietary fiber to their approved list.  The details can be found FDA Issues Guidance, Science Review, and Citizen Petition Responses on Dietary Fiber (14 Jun 2018).

New dietary fibers

  1. mixed plant cell wall fibers
    • a broad category that includes fibers like sugar cane fiber and apple fiber, among many others
  2. arabinoxylan
  3. alginate
  4. inulin and inulin-type fructans
  5. high amylose starch (resistant starch 2)
  6. galactooligosaccharide
  7. polydextrose
  8. resistant maltodextrin/dextrin

Previously approved dietary fibers:

  1. [beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A));
  2. Psyllium husk (as described in § 101.81(c)(2)(ii)(B));
  3. Cellulose;
  4. Guar gum;
  5. Pectin;
  6. Locust bean gum;
  7. Hydroxypropylmethylcellulose.

 

For Additional Information:

June 12, 2018

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Label Training – Cal Poly Pomona

In case you missed it, we thought we’d share some photos…. contact us at ‘debra at knowledge-bank.net’ if you’d like training on-site at your business.

For the full press release see: http://www.cpp.edu/~agri/news/2018-food-labeling-workshop.shtml

 


Bare Bones of Food Label Regulations

Food Label Training

Scheduled for April 26, 2018 AND HOSTED BY the Don B. Huntley College of Agriculture at Cal Poly Pomona (California)

TOPICS COVERED

  • How to make an ingredient declaration and allergen statement
  • What is a product name and characterizing flavor on the front-of-pack
  • When can a claim be made for “free from” or “packed with” for nutrients like calcium or fiber
  • The graphic differences and nutrient definitions for “old” and “new” nutrition facts formats
  • How a daily value and rounding rules work for Vitamins, Minerals, Fiber and Protein
  • When to “count” an ingredient as an added sugar or dietary fiber for labeling purposes
  • What makes a serving size and how this affects servings per container or the new dual column formats
  • Regulatory agency involvement in labeling enforcement
  • Why bragging about a good nutrient requires disclosure about other nutrients

Click here to download the Poster.

To register visit: www.cpplabel.eventbrite.com

Too many food companies find out there IS a labeling regulation when they are first threatened by a lawsuit or notified of regulatory agency action.  Get the bare bones of USA food label regulations in this 7-hour workshop hosted by Cal Poly Pomona.  This beginning workshop is for those new to what must appear on a food label.  The workshop is intended for food industry professionals, agri-business faculty, entrepreneurs, registered dietitians, food science & food-related business students.

The practical tools and examples will help attendees create a skeleton of the 7-basic label elements. Take the fright out of how to declare “added sugars”, “additives”, and “dietary fibers” when transforming labels before the new nutrition facts deadline of July 2018. The workshop will demonstrate where to find the rules, calculations, and disclosures for the basic “packed with” or “free from” nutrient claims.

Save the date: Thursday, April 26, 2018 at Agriscapes at Cal Poly Pomona.  Visit www.cpplabel.eventbrite.com for upcoming information and registration details.   Continuing Education Units/Contact Hours have been applied for through the International Food Science Certification Commission (IFSCC) for certified food scientists and Academy of Nutrition & Dietetics.

Presenter:

Debra KW Topham, MS, CNS, CFS, Director of knowledge bank

Debra is director at Knowledge Bank. Her boutique consulting firm provides “health checkups” for USA food and supplement labels as well as substantiation reports for ingredient claims. The Huntington Beach, CA consulting service checks that USA product labels & sell sheets including nutrient and health claims are in compliance with FDA, USDA, and FTC regulations.  Debra is a 35-year veteran of the food industry with experience reviewing more than 3,000 product labels for her clients and Fresh&Easy Neighborhood Market and soon the software launch of ReviewQ®.  She is a Certified Nutrition Specialist and Certified Food Scientist and adjunct lecturer for local universities.