September 12, 2017

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Eat your peanuts!

Moms are always saying to their kids – “eat your veggies.”  Now add “Eat your Peanuts!” to the list.  But read the fine print before you go off and make any new claims.

The FDA now acknowledges that there is sufficient evidence”Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy

As a new qualified health claim you may now start saying:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.

If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

Clearly this is not a broad blanket statement. But this is a great step forward for the food industry. First, Assured Bites, proves that a company can petition for a qualified claim; and secondly they serve as a real example as to what’s needed to meet the FDA’s rigorous standards.

This also provides the starting point to become  an authorized health claim.

The FDA provides a nice explanation between the “qualified” versus “authorized” health claim:  “The qualified health claim was in response to a petition filed by Assured Bites, Inc. Qualified health claims are not the same as “authorized health claims,” which must be supported by significant scientific agreement among experts in the field. Qualified health claims are supported by credible scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. As such, they are accompanied by qualifying language or a disclaimer so that the level of scientific evidence supporting the claim is accurately communicated.”



September 11, 2017

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Olde “PreDSHEA” Dietary Ingredients

For Colleagues in the Dietary Supplement World.


Speak now or forever hold your peace…(or piece)….regarding “old” dietary ingredient determinations by FDA.


Be sure to alert your trade groups for your preferences/opinions if you don’t want to be known by name.


Deadline for comments is December 4th, 2017.


On October 3, 2017 the FDA is holding a meeting in  Maryland on “Develop[ing] of a List of Pre-DSHEA Dietary Ingredients”


However, if you want to make an oral presentation, you have only until Sept 18th to request time on the agenda.


Note: that although a webinar is offered; Knowledge Bank has experienced cases where webinar/broadcasts failed to occur for “purported” technological reasons and thus no public video of the program was ever made available.


Important Dates to Remember

  • September 18, 2017  – Request to make an oral presentation
  • September 18, 2017 – Request special accommodations due to disability
  • September 25, 2017 – Registration Deadline
  • October 3, 2017 – Public Meeting
  • December 4, 2017 – Deadline to submit electronic or written comments to docket FDA-2017-N-4625

See full FDA posting here.

September 11, 2017

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The Paradox of Federal Paperwork Reduction – Your Chance to Be Heard!

Few real paradoxes exist. Is it the Chicken or the Egg?


The federal government has no problem with paradoxes. The government passed laws (or rather an executive order), and thus increased the paperwork.  Ironically this executive order aims to reduce paperwork.


Once again the adage, that you have to move backwards to move forward applies. In this case, it is a very good thing.


It’s your chance to be heard. Specifically the FDA and USDA are  formally “seeking seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.”

Here is the FDA and USDA’s list of requests for paperwork reduction:


Some sample questions include:

  • Is the regulation still current, or is it outdated or unnecessary in some way?
  • Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
  • Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?
  • If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
  • Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
  • Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.</bullet

If you are curious about President Trump’s executive order 13771, “Reducing Regulation and Controlling Regulatory Costs” the full text is here.

August 29, 2017

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“Genetically engineered” – Suing the USDA

The Center for Food Safety [CFFS] filed suit in Sacramento, California, against the United States Department of Agriculture [USDA], for failing to move quickly enough to implement federally mandated regulations on genetically engineered foods.  The full filing can be read here.


In their suit, CFFS states, “The American people have advocated for mandatory labeling of genetically engineered (GE) foods for nearly two decades.”  They go on to argue that a delay, is causing harm. Specially they say:


“Congress placed express deadlines in the statute for USDA’s compliance…[to issue a] standard for GE foods…to meet that…deadline, Congress required that the study on digital and electronic disclosures be completed by….July 29, 2017. 10. That express statutory deadline has now passed, and USDA has failed to publicly release the study, or provide for public comment….delay of this process is likely to delay the rules themselves, causing still more harm to the public and the stakeholders, who have already waited many years. USDA must act now….to prevent further statutory violations and further harm to the consumers.”


No matter the outcome of the suit, consumers want information on their food labels. Consumers want to be able to pick up a food label and make a choice about that food. The question many consumers ask is: Does this food align with my food philosophy?  Knowing if a food does or does not contain genetically engineered food is critical to making this decision.


What does this mean for the industry? Brand owners, contract manufacturers, suppliers, flavor houses, etc.. will need to know what genetic foods are in their products. They will need to document and communicate well.  Consumers will expect that all “genetically engineered” information will be correct!





August 29, 2017

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Tiffany foods anyone?

Tiffany Setting the Standard

Venable LLC, recently posted a summary of the Tiffany vs Costco trademark infringement lawsuit.  The full article is worth a quick read. Essentially using “Tiffany” to describe a ring, such as “Tiffany ring” or “Tiffany settings” is just fine.  But using Tiffany alone is not.  Tiffany® is a registered trademark. The federal judge ordered Costco to pay $19.4 million for trademark infringement and trademark counterfeiting.

So what does this have to do with food and supplement labels? Marketers are creative and always looking for creative romance copy.  A good review should look for and identify risky terms.

Take a quick quiz? From this list, which terms are trademarked?

  • Doritos
  • Hatch
  • Cha Cha Cha
  • Tabasco
  • Sriracha
  • Yellowstone

All of them, except Sriracha. Check for yourself at the trademark search site.

Bottom line – know what the words you use mean; conduct a trademark search; and seek professional help.


August 23, 2017

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FDA Food Label Training

Two Interactive Food Label Training Choices


Text Box


Debra Topham, Knowledge Bank director and 30-year veteran shares her knowledge on food label regulations:



  • Food Label Training Overview
  • Nutrition Facts Reformation & Transformation

Basic Food Label Training Thursday Sept 21, 2017 9am—4:30pm

A 1-day overview of the US FDA regulations for adult foods with nutrition facts panels. Get an introduction to nutrient content claims regarding “good source” or “packed with” along with guidance in choosing the properly labeled serving sizes. Activities will show how to create basic ingredient lists, select a product. $850 per person

NFP 2016 Update Friday Sept 22, 2017 9am –12noon

Back-of-pack nutrient changes will be at the front of customer inquiries, enforcement, and potential litigation for millions of USA products. In this 1⁄2-day session, learn through relevant case studies, what lies ahead of you to meet the 2016 Federal Register announced labeling regulations. See what changes to nutrient definitions will affect label claims when switching to the new regulations. Course covers the FDA 2016 Nutrition Facts updates & requires prior regulatory training. $385 per person


Food Microbiological Laboratories,10653 Progress Way, Cypress, CA 90630




B&W handouts of presentation slides with worksheets & reference materials. Parking Pass and boxed lunch for pre-registered attendees.
Ask about professional contact hours for Certified Food Scientists!

Register at:
P: 657.464.3834 E:

Presented by Debra KW Topham, MS, CNS, CFS

Knowledge Bank provides “health checkups” for food and supplement labels to comply with FDA, USDA, and FTC regulations. Debra is the Director and 30-year veteran with Fresh&Easy Neighborhood Market, Nutrilite, and now the upcoming software launch of ReviewQ.

Knowledge Bank reserves the right to cancel the programs and refund registration fees if enrollment is low. Attendees may cancel up to 7 calendar days before the event less a $50 processing fee or send a professional replacement from the same company.


August 18, 2017

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Image - Dog ready for Vacation in airport terminal

FSMA User Fees Make No Sense

The Food Safety Modernization Act (FSMA) reinspection fees make no sense!

Under the FSMA, the FDA is allowed to collect user fees for reinspections (see FDA Fee Guidance).  Although the FDA has not yet collected fees, you should pay attention to them.

The FDA started publishing its domestic and foreign reinspection fees in 2013.

If you chart these fees (see inset image), their logic makes absolutely no sense.  The foreign costs are going down and the domestic costs are going up.

 if the trend continues, in ~13 1/2  years, the costs to have an inspection in San Paulo  will will less expensive than New York.

Further, the changes from one year to another do not make sense. The Consumer Price Index (see Bureau Labor Statistics) since 2013 has annually  varied from -0.1 and +2.0%.  Whereas reinspection fees have varied from -10% and +12%.

All we can say is make sure you have contingency budget set aside should the FDA actually start collecting what it has the authority to collect.


August 10, 2017

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Free service – find archived FDA Warning Letters

Knowledge Bank has launched a free service (  to search archived warning letters.

Why did we do that? The FDA site stopped working the way we wanted.

See for yourself…

Go to FDA.Gov and search for “Sunshine.”  You won’t find anything older than 2012.
Inline image 1
Now search our site – — and you’ll find all the letters from 2005-2011.
Inline image 3
If you find this useful, let us know.
If you can think of other tools that would be useful, let us know.

July 31, 2017

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Food Label Regulations Status – 2017 Update

2017 Semi-Annual Regulatory Agenda

The White House Office of Management and Budget (OMB) published its 2017 Semi-Annual Regulatory Agenda for each agency.

We’ve gone through the report and listings and highlight impacts to food labeling.

Background: January 30th, 2017, Trump signed an executive order requiring that for every one new regulation, two must be revoked.

The impact of this executive order can be seen in the recently published 2017 Semi-Annual Regulatory Agenda which is posted on by the OMB.

You can find current, long-term and inactive regulations.

Current Labeling Regulations

Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Expected October 2017

FDA is proposing to amend its regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease on the label or in the labeling of foods.  Under the FD&C Act “health claims,” which characterize the relationship of a food to a disease or health-related condition, must be authorized by FDA before they can be used.  The science supporting this claim is not sufficient to meet the statutory standard for FDA authorization, but there is some evidence supporting a soy protein benefit on coronary heart disease that FDA would allow as discussed in its guidance documents: 1) FDA’s Implementation of Qualified Health Claims; Questions; and Answers and 2) Evidence-Based Review System for the Scientific Evaluation of Health Claims. Ref: 0910-AH43

Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods –

Expected October 2018

This proposed rule would establish requirements concerning compliance for using a “gluten-free” labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food 0910-AH00

Long Term Labeling Regulations

Updated Standards for Labeling of Pet Food

Expected TBD

FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about the nutrient content and ingredient composition of pet food products. 0910-AG09

New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food

Expected October 2018

FDA is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved applications for conditional approval of new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, the Agency is proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.  0910-AG17

Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages

Expected TBD

Pursuant to the House Committee Report accompanying the Food Allergen Labeling and Consumer Protection Act of 2004 (Pub. L. 108-282), TTB will consider how to appropriately apply allergen labeling to beverage alcohol products. We will consider how allergen labeling for these products will operate within our existing labeling regulations and with FDA regulations. 1513-AB08

Inactive Labeling Regulations


  • National Organic Program, Organic Pet Food Standards 0581-AD20
  • National Bioengineered Food Disclosure Standard 0581-AD54
  • Product Labeling: Use of the Voluntary Claim “Natural” on the Labeling of Meat and Poultry Products 0583-AD30
  • Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed 0583-AD56
  • Labeling of Meat Food Products Derived From Calves 0583-AD63


  • FDA Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements 0910-AB88
  • FDA Food Standards: General Principles and Food Standards Modernization 0910-AC54
  • FDA Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
  • FDA Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH09
  • FDA Laboratory Accreditation for Analyses of Food 0910-AH31




July 29, 2017

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FDA Recruiting Watchdogs

In a recent post “Dietary supplement concerns? Tell the FTC and FDA” both Mary Engle , FTC Associate Director, Division of Advertising Practices, and Steven Tave, FDA’s Director, Office of Dietary Supplement Programs, called on the public to help them police the industry.

  • “You bought a dietary supplement that didn’t work as advertised – or you had an adverse reaction or illness.”
  • “You’re suspicious that a company is making false or overstated claims in its labeling or marketing.”
  • “Concerned about a statement made on a product label or other packaging, or about the content or purity of the product?”
  • “Think a claim seems false, unsupported, or simply unbelievable? Does it promise to treat or cure a disease? Tell the FTC. “

Although their call for public help is a bit rambling and not too specific, the main point is “IT IS A PLEA FOR HELP” – the agency has not been particularly good about engaging the public for help.

According to a NutraIngredients blog posting, they quote Dan Fabricant (see bloomberg bio), president and CEO of the Natural Products Association and former head of FDA Dietary Supplement Programs, who suggests the FDA’s plea for help is a direct response to the General Accounting Office recommendation The “GAO recommends that FDA and FTC provide additional guidance to consumers clarifying the agencies’ differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet. The two agencies concurred with GAO’s recommendation.”