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 a ‘clientservices at knowledge-bank.net’ if you’d like training on-stie 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

May 9, 2018

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FDA formally sets Nutrition Facts & Supplement Facts compliance date of 1/1/2020

May 4, 2018, the FDA has announced:

 

U.S. Food and Drug Administration formalized the new compliance deadline to update the Nutrition Facts and Supplement Facts labels as January 1, 2020 for large manufacturers (and January 1, 2021 for small manufacturers). On that date, all labels must be applied to retail food and dietary supplement packages with the most recent regulatory updates for nutrition values and formats. The original compliance date was July 26, 2018 (or 2019) which was two years after the regulations were announced on May 26, 2016. [Hence the confusion whether the “new” regulations are 2016 or 2018 “versions”!] The extension had been mentioned by FDA but not formalized until now. “Large” manufacturers is set by FDA as those with $10 million or more in annual (global) food sales while “small” manufacturers means those with less than $10 million in annual food (global) sales. The agency published a proposed rule

 

The approximately 18-month extension is to help companies gather more information and to provide sufficient time to also add the required label disclosure of genetically engineered content announced today by the USDA. The transition will take many person-hours to adapt to the new reference serving sizes, document added sugar content, reformulate if manufacturers want to keep fiber claims, and a host of other formatting changes that the software databases have not accommodated.

 

The FDA is also committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates. A full list of Nutrition Facts-related guidance documents is available on the FDA website.

For Additional Information:

May 9, 2018

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Federal Organic and GMO labeling rules proposed by USDA

 

The United States Department of Agriculture released its proposed rules for declaring “bio-engineered food ingredient” content on most foods that are not organically certified. The required disclosure will a federally mandated message rather than a warning, as is the case of with high risk products.

 

Industry and consumers only have until July 3, 2018 to make comments to the proposed rules–with no hope of an extension. USDA has set compliance dates to coincide with the FDA’s new nutrition facts and supplement facts label updates: January 1, 2020 (or 2021 for small manufacturers).

 

Comments are requested by the USDA regarding which disclosures are most suitable and if “TWO pre-approved lists of agricultural crops” make the most practical sense for designation of “b-e” foods and “b-e” food ingredients. The lists would be updated periodically and USDA is seeking comments on this practicality, too.

 

Comments may be submitted online through the Federal eRulemaking portal www.regulations.gov beginning Friday May 4. Comments may also be filed with the Docket Clerk, 1400 Independence Ave., SW, Room 4543-South, Washington, DC 20250; Fax: (202) 690-0338.

The deadline for comments is July 3, 2018

 

The USDA is proposing disclosures on packages –similar to the National Organic Program regulations–in the form of:

  1. logos,
  2. phone numbers that may receive text messages,
  3. electronic codes, or
  4. a designated phrase

The disclosure will not use the popular terms “Genetically Modified Organism” or “GMO”. Rather the USDA believes “bio-engineered” is a more realistic  term to comply to the law signed in 2016. This was the federal law enacted to avert a state-by-state patchwork of GMO-labeling laws.

 

 

The National Bioengineered Food Disclosure Standard Law was enacted by Congress on July 29, 2016. The proposed rule previewed in the May 3, Federal Register.

April 30, 2018

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If you milk a plant, is it still milk?

Food Navigator alerts us to the FDA commissioner Dr. Scott Gottlieb presenting before a recent Senate Appropriations Committee, in which Wisconsin Senator Tammy Baldwin introduced the Dairy Pride Act.

 

  • In short, the Gottlieb, says the FDA hasn’t enforced the term “milk” and “yogurt”, and consequently there are many plant-based alternatives in the market now.
  • The FDA will “actively look” into the matter, but reversing policy course has many repercussions, so they will look into the matter with care.

 

In other words the FDA didn’t bow down to the Senator. In looking at these situations, I often remind myself that the FDA’s charter primarily focuses on managing public safety risk.  Ensuring Fair Trade is generally the domain of the Federal Trade Commission.

 

The FDA and FTC work together, but the questions that need to be worked out are: Is the consumer at risk? Is the consumer harmed? Can the consumer tell the difference between a “plant based protein milk” and  “bovine milk.?” Is there a commercial unfairness?  I don’t know the answers to these questions?

 

According to Statista California is the leading cow’s milk producer and Wisconsin is second.  So why isn’t the California and Wisconsin Senators co-authors of the bill? I wonder if it has to do with Silicon Valley spending millions on plant based startups?

 

Food Navitator: FDA commissioner weighs into plant-based ‘milk’ debate

FDA commissioner Dr Scott Gottlieb says the agency is “actively” exploring whether consumers are being misled by the use of terms such as ‘milk’ or ‘yogurt’ to describe plant based products, but says the FDA’s radio silence on this issue in recent years may make it harder to take action now without new data.

April 16, 2018

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Caffeinated Dietary Supplements on the FDA High Risk Radar Screen

Dear Colleagues

Forwarding FDA news about caffeine—which can apply to caffeine derived from green tea.  Immediate concern is any bulk sales of caffeinated supplements directly to consumers that are not “pre-measured” to control dosing (including products measured with a “scoop”).

“The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk.”

PDF of guidance is here https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf

Assuming that the product otherwise complies with all applicable legal requirements, we do not expect to consider the following types of dietary supplements to be adulterated:

  1. Dietary supplements sold in solid dosage forms, such as tablets or capsules that do not provide an excessive amount of caffeine per item. Products in these forms eliminate the need for a consumer to accurately measure the appropriate serving.
  2. Dietary supplements containing powdered or liquid caffeine (either diluted or undiluted) that are sold in premeasured packets or containers, with each premeasured unit containing an amount of caffeine that is not excessive. Products that are sold in pre-measured quantities eliminate the need for a consumer to measure the appropriate amount.
  3. Bulk powdered or liquid caffeine dietary supplement products that have been significantly diluted to low enough concentrations of caffeine, such that a reasonably foreseeable measurement error, misreading of the directions, or misunderstanding about the nature of the product would not normally be expected to lead to toxic or life-threatening symptoms.

All dietary supplements are required to comply with the adulteration provisions of the FD&C Act, and we intend to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form.

Thankyou Debra Topham