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Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related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 28, 2018

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Want healthier foods? Let the FDA Know

 

FDA Announces Public Meeting to Discuss Nutrition Innovation Strategy Implementation

Full posting available here

June 26, 2018

The U.S. Food and Drug Administration announced today a public meeting to discuss the agency’s Nutrition Innovation Strategy. In a statement released today, Commissioner Scott Gottlieb, M.D., emphasized that the public meeting will begin an important dialogue on various aspects of the strategy with a variety of stakeholders. In his March 29 speech to the National Food Policy Conference, the Commissioner recognized the critical role the FDA plays in protecting public health through improvements to the nutritional profile of foods that compose the American diet. He stated that developing strategies to improve nutrition can be a transformative step toward reducing the burden of many chronic diseases, ranging from diabetes to certain cancers to heart disease. As such, the FDA is hosting a public meeting to give interested parties an opportunity to discuss various features of the FDA’s Nutrition Innovation Strategy, which promotes public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease.

Since announcing the Strategy earlier this year, the FDA has identified several areas where it believes there are opportunities to improve FDA’s approach to nutrition policy, by encouraging industry innovation to improve the nutrition and healthfulness of food and by providing consumers with informative food labeling to make healthy food choices. These tactics include developing a standard icon or symbol for the claim “healthy;” a more efficient review strategy for the FDA to employ when evaluating qualified health claims; allowing for labeling statements or claims on food products that could facilitate innovation to promote healthful eating patterns; approaches for modernizing standards of identity; possible changes that could make ingredient information more consumer friendly; and implementing the FDA’s educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace.

The meeting will be held on July 26 from 8:30 a.m. until 5:30 p.m. at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852 and include introductory presentations, panels, oral presentations by participants as well as breakout sessions. Public meeting attendees are encouraged to register online to attend the meeting in person and via live webcast.

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.

May 18, 2018

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Ignoring Partially Hydrogenated Oils (PHOs) could be dangerous to your business. Smile, the FDA “might” have given you more time to be a hero!

Back in 2015, partially hydrogenated oils (PHOs) were ruled unsafe for human consumption. The FDA’s original final decision can be found here. The deadline for removing PHOs, for the vast majority, remains June 18th 2018 — just 30 days away!

 

But today the FDA announced — “FDA Extends Compliance Date for Certain Uses of Partially Hydrogenated Oils in Food; Denies Petition for Certain Uses of PHOs

 

“For the majority of uses of PHOs, June 18, 2018 remains the date after which manufacturers cannot add PHOs to foods. However, to allow for an orderly transition in the marketplace, the FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. The FDA is extending the compliance date for these foods to January 1, 2020. This action balances the health benefits of removing PHOs from the food supply with the need to provide an orderly transition in the marketplace.”

 

“At the same time, the FDA is denying a food additive petition from the Grocery Manufacturers Association (GMA) requesting approval for certain limited uses of PHOs. To allow for time for reformulation, the agency is extending until June 18, 2019 the compliance date to stop manufacturing foods with these specific, limited petitioned uses of PHOs, and until Jan. 1, 2021 for these products to work their way through distribution.”

 

“For convenience, FDA is summarizing the extended compliance dates as follows:

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021