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 makes 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 starting 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.”



July 28, 2017

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FDA Approved – Macadamia Nuts Health Claim

Macadamia nut manufacturers can immediately start using:

“Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

In typical FDA fashion, on July 24th 2017, the FDA released a “constituent update.”  – “FDA Completes Review of Qualified Health Claim Petition for Macadamia Nuts and the Risk of Coronary Heart Disease


July 28, 2017

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Sugar under attack again

Sugar is in the news on multiple fronts. It’s clear sugar is under attack.  Products with sugar will be scrutinized. Products labels will be read. Consumers will begin questioning their sweeteners more and more.

CSPI Refiles Lawsuit Alleging Coca-Cola and ABA Deceived Consumers on Health Risks Keller and Heckman LLP

“Center for Science in the Public Interest (CSPI), a consumer-advocacy group, filed a complaint claiming that Coca-Cola and the American Beverage Association (ABA) misled consumers regarding the health risks of consuming sugary drinks such as soda.  The lawsuit specifically takes issue with Coca-Cola and the ABA’s emphasis on “calories in, calories out” and exercise as the best ways to manage health…The suit also alleges that Coca-Cola purposefully misled consumers on the health risks of drinking soda by funding research that downplays the dangers of sugary beverages. more

Should soda with non-caloric sweeteners be taxed too? In Philadelphia and Cook County, that’s the case.  Food Navigator

“Proponents of sin taxes say that putting a levy on sugar-sweetened drinks may play a pivotal role in fighting obesity, diabetes, and cardiovascular disease. But two of the eight US locations that have passed such a tax—Cook County (Chicago) and Philadelphia —passed ordinances that tax beverages with non-caloric sweeteners as well.” more

Coca-Cola’s earnings, sales top Wall Street expectations with more healthy drinks on tap CNBC

“With a new chief executive at the helm, Coca-Cola on Wednesday reported earnings and revenue that topped analysts’ expectations. The beverage maker also issued a more upbeat earnings forecast for the full year.

Increasingly, shoppers are searching for Coke’s healthier options — low in sugar and free of carbonation — which fueled these results, though Coca-Cola posted another drop in profit as it’s still in the midst of completing a refranchising plan.” more

In short check your products, ask yourself…

  • What sugars and sweeteners do I have in my products?
  • What do consumers know and think about those sweeteners. What are the trends?
  • What do my labels look like now?
  • What will my labels look like if I reformulate?
  • What will my labels look like under 1993 or 2016 labeling rule?
  • If I stick with 1993 rules, what will consumers think when I switch to 2016 labels that must list added sugars separately?

July 14, 2017

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Lipstick on a Pig

Debra Topham, Director for Knowledge Bank –  spoke at this year’s IFT meeting; and was picked up by the news by Mary Ellen Kuhn.

Debra Topham

This is not simply putting lipstick on a pig

Debra Topham in a session titled “Navigating the New Nutrition Labeling Regulations for Various Segments of the Food Industry.” It’s a serious mistake to believe that label changes can be accomplished quickly and easily, said Topham. “I’m here to tell you that that is a myth.

“This is not simply putting lipstick on a pig,” she continued. “You will not find it easy to take the old numbers and slap them into a new format.” For one thing, she observed, not all labeling software is created equal, so it’s important to exercise caution in this area. “Not all software is generating [data] that is compliant with the new Nutrition Facts format.”

July 14, 2017

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Sign with phrase Ask More Questions

New Guidance for California Prop 65

California Office of Environmental Health Hazard Assessment (OEHHA) has posted new guidance for Proposition 65 Clear and Reasonable Warning regulations.


OEHHA announced on September 2, 2016, their final rule concerning California Proposition 65 “clear and reasonable warnings” the would be effective August 30, 2018. 


Here’s just a few of the Q&A. But we recommend the Q&A fully at Link for OEHHA’s PDF.

Can a business replace the September 2008 warnings and provide the new warnings immediately? Yes, during the two-year phase-in period from August 30, 2016 to August 30, 2018, a business can follow the safe harbor methods and content from either the September 2008 regulations or the new regulations (Section 25600(b)).


Who should provide a warning? Consistent with the Act, OEHHA’s new regulations place primary responsibility for providing warnings on

  • product manufacturers
  • producers
  • packagers
  • importers
  • suppliers
  • distributors.

…businesses…must either provide a warning on the product, or provide notice and warning materials to “the authorized agent” for a retail seller and receive an acknowledgment that the notice and materials were received. The retail seller is responsible for placement and maintenance of the warning materials he/she receives from the product manufacturer, producer, packager, importer, supplier or distributor. Businesses should carefully review the new requirements (Section 25600.2).


Can a business provide a general Proposition 65 warning at each public entrance to a store instead of providing warnings for specific consumer products? No. A standalone warning at public entrances purporting to cover all possible consumer product exposures would not meet the requirements for safe harbor warnings under the new regulations

July 13, 2017


Can you be truthful and misleading?

In a recent Food Navigator article  Odwalla ‘no added sugar’ case to go to private mediation by Elaine Watson+, 12-Jul-2017, the California court has ordered Odwalla into private mediation to resolve a dispute over ‘no added sugar’ claims on 100% juice products.

Why the lawsuit?

In short a truthful claim is misleading! WHAT?@#$? Let’s dissect the issue.

Odwalla proudly displays the claim “No Added Sugars” – that’s a truthful statement, as 100% has nothing added.

What does the regulation say?  21 CFR 101.6(c)(2)

(2) The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if:

(i) No amount of sugars, as defined in §101.9(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging; and

(ii) The product does not contain an ingredient containing added sugars such as jam, jelly, or concentrated fruit juice; and

(iii) The sugars content has not been increased above the amount present in the ingredients by some means such as the use of enzymes, except where the intended functional effect of the process is not to increase the sugars content of a food, and a functionally insignificant increase in sugars results; and

(iv) The food that it resembles and for which it substitutes normally contains added sugars; and

(v) The product bears a statement that the food is not “low calorie” or “calorie reduced” (unless the food meets the requirements for a “low” or “reduced calorie” food) and that directs consumers’ attention to the nutrition panel for further information on sugar and calorie content.

So technically, 100% orange juice is not a substitute for 100% juice, and thus Odwalla product mislead the consumer and was ‘mislabeld.’


The issue is now in arbitration, we’ll have to wait for the outcome.

Bottom line, know what your claims mean – read all the text or hire an expert that does it for you.  But a truthful phrase,  “No added sugars” has caused Odwalla (i.e. Pepsicola) a lot.


June 22, 2017

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Nutrition Facts Label Deadline Extended

FDA Intends to Extend Compliance Dates for Nutrition Facts Label Final Rules

Updated Jun 22, 2017: Scott Gottlieb assured the Senate “This is a time-limited delay. This is not a suspension of the regulation. We are not reopening the regulation.”  Source Keller and Heckman LLP.

Posted June 14, 2017

In May 2016, the U.S. Food and Drug Administration finalized the Nutrition Facts and Supplement Facts Label and Serving Size final rules and set the compliance date for July 26, 2018, with an additional year to comply for manufacturers with annual food sales of less than $10 million. After those rules were finalized, industry and consumer groups provided the FDA with feedback regarding the compliance dates. After careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.

As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation. The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace. The FDA will provide details of the extension through a Federal Register Notice at a later time. (Source: FDA — Note: The FDA buried the information under “compliance date” section.)

Knowledge Bank’s take – you can check out the following to see the diverging opinions as to ‘why’ the extension.

  • Food Navigator–  ACI FOOD LAW FORUM: GMO labeling blues, Nutrition Facts delays, daily values and de-fortification, and will the FDA ever nail down natural?
  • CNBC – FDA delays rule requiring new nutrition facts panel on food
  • The National Law Review -FDA to Extend Compliance Dates for Nutrition Facts Label Changes
  • Associated Press / The New York Time – FDA Delays Revamped Nutrition Facts Panel