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  Older warning letters (2005-2012) have been archived and are no longer available or searchable on the FDA’s website.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)


  • 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.


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:

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

April 9, 2018

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Final Guidance on Data Integrity – The FDA was beat to the punch by the British Medicines and Healthcare Products Regulatory Agency

Hyman Phelps MacNamara PC’s LawBlog brings us this news “Agency Publishes Final Guidance on Data Integrity – the British Medicines and Healthcare Products Regulatory Agency that is


As the article points out, the FDA draft guidance was published two years ago. The British [or more formally the British Medicines and Healthcare Products Regulatory Agency (MHRA)] beat the FDA and published a  guidance on “GXP Data Integrity.”  Even though the FDA has yet to finalize its guidance I’m sure someone at the FDA has been tasked to read what the British wrote, so we should too.


The LawBlog does a good job summing up the data integrity principals which I’ll further summarize.

  • An organization should ensure that data is complete, consistent and accurate in all its forms.
  • Appropriate data integrity controls are necessary for all systems both manual or computerized.
  • As with any system, when gaps or weaknesses are found, an appropriate corrective and preventive actions are implemented holistically.
  • The British extends the FDA’s ALCOA concept to ALCOA+; Data integrity is:
    • Attributable, Legible, Contemporaneous, Original, and Accurate,
    • PLUS
      • Complete (i.e., the data must be whole – a complete set),
      • Consistent (i.e., the data must be self-consistent),
      • Enduring (i.e., lasting throughout the data lifecycle)
      • Available (i.e., readily available for review or inspection purposes);
    • I guess they called it ALCOA+ because ALCOACCEA looks like a new latin species name.
  • Data integrity effort considers the risk to product or patient (e.g. reduced risk reduced effort; high risk high effort)
  • Systems and processes should be designed in a way that facilitates compliance with the principles of data integrity;
  • Paper systems (should be controlled as if they could be tampered with) —  for example, use of controlled books with numbered pages, may be necessary to prevent the re-creation of a paper record;
  • Using a scribe to record on another’s behalf is acceptable, providing everyone signs off and everything is done at the same time.
  • Data doesn’t need to be saved just because it can be saved. However, the exclusion of data must be justified (at a level similar to that followed by the scientific method)
  • Basic security principals, apply, such as to limit access to the minimum necessary data access for a person to perform their role; and tighter controls are needed for people with elevated (i.e. system administrator) access
  • As with all risk management systems, organizations are expected to implement, design and operate a documented system that manages an appropriate and acceptable data integrity risk.  This means the rational for acceptable risk needs to be documented, such as creating a data integrity risk assessment (DIRA)



Knowledge Bank is NOT a legal firm; The materials available at this web site are for informational purposes only. Please consult with an attorney for all legal matters.

April 2, 2018

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Gottlieb speaks. Healthy, Qualified Claims, Allergies and overall Nutrition in Focus

As reported in several places, after what some consider two-years of radio silence, Scott Gottlieb, FDA Commissioner,  addressed the Consumer Federation of America’s National Food Policy Conference in Washington DC March on 30th 2018, with a speech outlining broad changes to FDA food policy. The full video and text transcription is available on CSPAN here


From opening about heart disease and cancer, Mr. Gottlieb quickly reminds us that  “we can’t lose sight of the public health basics like better diet, more exercise and smoking prevention and cessation.”


He goes on to say ” We know today people are eating too much food fighting to make cases there still a consuming enough of certain nutrients to achieve a balanced diet.  We’re keeping all of these considerations in mind as we pursue making an update to the definition of healthy.”


“We will also consider how to depict healthy on the package so that consumers can easily identify it, particularly when they may not have time or the skills exam all the information on the food package. To address this we’ve had discussions about whether there should be a standard icon or symbol for the word healthy that everyone could use on food packages”


“We also plan to seek input on other possible changes to our nutrient content claims ……we are also interested in exploring claims are products that offer food groups which american dies typically fall short of the current recommendations; For example, whole grains, low-fat dairy, fruits and vegetables and healthy oils.”


“[We want]..streamlined process for reviewing qualified health claims we receive from the industry … We need to consider how to enhance the…review process. For instance, we want to be able to triage those requests according to public health significance and to prioritize the review of those that are most meaningful and most science-based. One such example…use qualified health claims linking early peanut introduction to reduce risk of developing peanut allergy.”


“Our intention is to prioritize those qualified health claims in the most likely to have a health benefit and data based on the strongest science…”


Additional resources: