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


June 5, 2017

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Four Gluten Free Icons

FDA Finds 99.5% of foods sampled comply with “gluten-free”

You can breath a sigh of relief. When it comes to “Gluten-free” the industry is doing a good job.  The FDA recently reported its findings. A copy of their release is below.

FDA Sampling Finds High Level of Compliance with Gluten-Free Standards

Constituent Update

May 30, 2017

More than 99.5 percent of sampled food products labeled “gluten-free” are in compliance with FDA’s requirement that such foods have less than 20 ppm (parts per million) of gluten.

This is the finding of an FDA sampling assignment in which 702 samples from more than 250 products labeled “gluten free” were collected and analyzed. Only one of those products was found to not comply with one of the major FDA requirements that went into effect in August 2014 for manufacturers using the term “gluten-free” on their labeling. This product was recalled and subsequent sampling by the FDA did not find levels of gluten that violated the regulation.

FDA set standards for gluten-free labeling to give consumers with celiac disease confidence about what the term “gluten-free” means on foods that carry this label. May is Celiac Awareness Month. People with this disease are at risk of very serious health problems if they eat gluten, found in breads, cakes, cereals, pasta and many other foods containing wheat and related grains. The sampling was undertaken from July 2015 to August 2016 to gauge the level of compliance with one of the major requirements of the gluten-free labeling rule.

For More Information

May 5, 2017

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Snail racing to finish line

Restaurant Nutrition Labeling Deadline Extended

Steady but sure…

Restaurant labeling deadline to be extended. “In the Federal Register of December 30, 2016, we [FDA] stated that the compliance date for the final rule would be May 5, 2017. We are extending the compliance date to May 7, 2018. We are taking this action to enable us to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration’s policies.”

When you read the May 4th 2017 Federal Register, you might think you have a reprieve and you do!  But don’t lose sight, that you will eventually need to cross the finish line. You will need to provide your restaurant customers with nutritional information.

Marketers know consumers need good information to make informed decisions about their food and health.  Take the reprieve to hone your systems. Start (if you haven’t already) providing nutritional information.  Then just update your format when the final ruling goes into effect.

See also:

March 21, 2017

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Image of Corn a source of High-Amylose Maize Resistant Starch used by new qualified health claim

Getting FDA approval for a qualified health claim

The following article is reprinted with permission; and provides an overview of the clinical trial research necessary to make a qualified health claim on front of food package labeling.   Companies needing a competitive edge must conduct rigorous studies to get a qualified health claim approved by the Food and Drug Administration.

High-Amylose Maize Resistant Starch Health Claim Approved for Type 2 Diabetes 

The U.S. Food and Drug Administration (FDA) recently approved a qualified health claim which will enable food companies to include messaging on the packaging of products which contain high-amylose maize resistant starch (HAM-RS). Type 2 diabetes (T2D) is characterized by insulin resistance which, over time, leads to exhaustion of the insulin-producing cells of the pancreas. Substantiation of the qualified health claim was supported by eight clinical trials, one of which was completed by members of the MB Clinical Research team. In this study, overweight and obese participants (11 men and 22 women) were randomly assigned to received either 0 (control), 15, or 30 g/d HAM-RS for four-week periods, separated by a three-week washout. In men, insulin sensitivity increased with daily intake of 15 and 30 g/d HAM-RS, relative to the control (48% and 56%, respectively, p <0.05 for both vs. control). However, there were no significant differences in insulin sensitivity for women, relative to control. The FDA concluded that the totality of the evidence supports the following claims:

“High-amylose maize resistant starch may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

“High-amylose maize resistant starch, a type of fiber, may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

Comment: We are hopeful that the approval of this qualified health claim will stimulate more research evaluating the effects of fermentable dietary fibers on carbohydrate metabolism. There is consistent evidence from observational studies that indicate higher consumption of certain fibers, especially cereal fibers, is associated with lower risks for metabolic syndrome and T2D. Research is needed to more clearly define the characteristics of dietary fibers that are associated with these benefits and to elucidate the underlying mechanisms. Based on our work and that of others, we hypothesize the liberation of short-chain fatty acids during fermentation of HAM-RS is a mechanism for enhanced insulin sensitivity. Other mechanisms may be important as well, particularly alterations in the microbiome.


U.S. Food and Drug Administration. RE: Petition for a Health Claim for High-Amylose Maize Starch (Containing Type-2 Resistant Starch) and Reduced Risk Type 2 Diabetes Mellitus (Docket Number FDA-2015-Q-2352-0023), December 12, 2016.


Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men.  J Nutr 2012;142:717-23.

March 1, 2017

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FDA Draft Guidance – Fruit and Vegetable Juice as Color Additives

Update:  The FDA has re-opened the public comment period. Comments are due by May 1st 217.  Source: FDA

Comment: We’ve recently seen multiple comment periods re-opened or extended. This appears consistent with the typical slowdown and adjustment as a new administration takes over. 

292_2708572The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.  


The fact that plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations.

As you read through the full  PDF, keep in mind the FDA’s quote above…the FDA worries about food safety. Its up to the food industry to prove a color additive is safe.”

January 4, 2017

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New FDA Guidance on Nutrition Facts Label and Serving Size

FDA Issues Two Guidance Documents on the Nutrition Facts Label and the Serving Size Final Rules


January 4, 2017


The U.S. Food and Drug Administration today issued two draft guidance documents related to the final rules on Nutrition Facts labeling and Serving Sizes to help industry comply with those rules.


The first draft guidance answers questions related to,

  • Labeling of added sugars
  • Rounding for declaration of quantitative amounts of vitamins and minerals
  • Label format (thickness of lines and space between lines).


The second draft guidance provides

  • Examples to help categorizing foods into the correct RACCs  (Reference Amounts Customarily Consumed per Eating Occasion) and thus determine the Nutrition Facts Label serving size.  (see PDF draft for complete table of example foods by category)


The final rules on the Nutrition Facts label and serving sizes published May 27, 2016. The compliance date is July 26, 2018, but smaller businesses with annual food sales that are less than $10 million have until July 26, 2019 to comply.


As, is always the case with “draft” guidance documents, there is a 60 day commentary period after publication in the Federal Register. Instructions for submitting comments can be found in the notices of availability at the links below:


For Additional Information:

Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals

Federal Register Notice for the Draft Guidance on Questions and Answers

Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category

Federal Register Notice for the Draft Guidance on Reference Amounts

Changes to the Nutrition Facts Label

December 16, 2016

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Raw Fruits and Vegetables Health Claims for Coronary Heart Disease

FDA Issues Interim Final Rule Allowing More Raw Fruits and Vegetables to Bear Health Claims about Relationship between Dietary Saturated Fat and Cholesterol and the Risk of Coronary Heart Disease December 16, 2016 The U.S. Food and Drug Administration is amending a regulation that authorizes a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to expand the use of the claim to certain raw fruits and vegetables that were previously ineligible

Source: FDA Issues Interim Final Rule Allowing More Raw Fruits and Vegetables to Bear Health Claims about Relationship between Dietary Saturated Fat and Cholesterol and the Risk of Coronary Heart Disease 

See also: Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease

December 16, 2016

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FDA OKs qualified health claim for resistant starch and diabetes

News that the US Food and Drug Administration (FDA) has approved a qualified health claim about high amylose maize resistant starch as a weapon in the fight against type 2 diabetes will start a much-needed conversation about the fiber, say experts.

By Elaine Watson+, 15-Dec-2016 /

Source: FDA OKs qualified health claim for resistant starch and diabetes



December 16, 2016

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Happy Holidays – FDA Gift Giving Guidance

The FDA doesn’t pre-approve labels, but if your thinking of sending the FDA free samples, you are in luck.   The FDA just announced its holiday gift policy and guidance “Gifts to FDA: Evaluation and Acceptance.”