March 23, 2017

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image of several harvested mushrooms

Labeling guidance for mushrooms.

The American Herbal Products Association recently adopted and published AHPA’s Fungi Product Labeling Guidance. The labeling guidance becomes effective March 9, 2019, though marketers may choose to apply the labeling guidance at any time.

KnowledgeBank’s view: Trade organizations will increasingly provide labeling guidance. Trade groups do this for many reasons:  to strengthen their industry, promote good practices such providing transparent information to the consumer and – last but not least – head-off imposed regulation. We can expect more guidance from existing and emerging trade organizations. 

AHPA’s announcment:  The guidance provides information to assist in compliance with current label regulations by including the common or usual name and the parts or stages of each fungi ingredient, and by listing ingredients in order of predominance by weight. In addition, under the guidance if the word “mushroom” appears on the label’s principal display panel, other than in the marketer’s company name, the parts of the fungal dietary ingredients in the product are voluntarily identified, e.g. “mushroom mycelium,” “mushroom spore.”

March 22, 2017

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FDA & Industry Dietary Supplements Seminar – May 10th – Bethesda

The FDA along with industry are hosting a one day seminar on Dietary supplements.  Topics include:

  • New Dietary Ingredients
  • Adverse Event Reporting,
  • FSMA (Food Safety Modernization Act)
  • GMPs (Good Manufacturing Practices)
  • Hold Notifications

For the complete agenda see PDF.

logo for American Herbal Products Association

logo for Consumer healthcare products association

logo for Center for Responsible Nutrition

logo for United Natural Products Alliance

United Natural Products Alliance

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 20, 2017

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The New FDA Chief nominee – Scott Gottlieb

With the administration’s announcement,  Scott Gottlieb is the new FDA Chief nominee, there has been a spate of articles with commentaries.  We’ve collected some here for you:

In all these cases, the articles focus on the impact to the drug industry; with keen attention to Dr. Gottleib ties to industry.  Foods or supplements are not even mentioned in the articles.

Public domain photo by Lawrence Jackson, courtesy of Wikimedia Commons/ Obama Speech on Health Care Reform 2012.



March 13, 2017

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Nutrition Label Training – Wednesday April 26th

New Nutrition Label Training – Wednesday April 26th 2017

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April 26, 2017

 Nutrition Facts  9am 12noon  ($385)

Supplement Facts  1:303:30pm  ($285)

  Location:  Food Microbiological Laboratories

10653 Progress Way, Cypress, CA 90630


These two sessions present the new US FDA regulations for food and supplement nutrition panels. Back-of-pack text changes will be at the front of customer inquiries, enforcement, and potential litigation for millions of USA products. Learn through hands-on demos and relevant case studies!  See what lies ahead of you to meet the July 26, 2018 or 2019 deadlines when the labels must be rightly applied on packages!


WHAT      you must do to comply with the new FDA regulations

HOW        to choose the most appropriate nutrition facts display

WHO        you need to talk to in your supply chain to get right details

Registration fee includes

B&W handouts of presentation slides with worksheets & reference materials.

Ask about professional contact hours for Certified Food Scientists!

Registration is limited to (12) twelve attendees per session.

Register at:

If you attend both sessions, please note lunch is not provided.


For additional questions, call Philip Topham @  (657) 464.3834 or contact via email at clientservices at


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.



March 9, 2017

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Attacking Groceries: 120+ Food & Beverage Startups In One Infographic

CBInsights brings us this amazing infographic and glimpse into new food brands.

  • The food and beverage startups in this graphic raised roughly $1.8B (yes that B for Billion!)
  • In each of the major food & beverage categories, the top 4 or fewer companies capture over 70% of the market
  • Smaller food companies (<$5B in sales) have gained 2.7 points of market share since 2011 — Boston Consulting Group report

Source: Attacking Groceries: 120+ Food & Beverage Startups In One Infographic

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.”

February 23, 2017

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California bill proposes warning labels on food with artificial colors

From Food Dive

  • California State Sen. Bob Wieckowski has introduced a bill requiring warning labels on food containing artificial colors in California, according to a release from his office.
  • The bill would make it a crime to sell artificially colored products in the state without a warning label on the package or bin where the product is sold. The bill would require that warnings tell consumers that synthetic dyes can cause behavior problems or hyperactivity in children, according to the bill.
  • In the press release announcing the legislation, Wieckowski states that similar labels are currently in use in Europe. “It’s important for parents to have this information as they seek ways to help their children who suffer from behavioral problems,” Wieckowski said. “Raising awareness through warning labels will educate parents about the adverse effects of food dye and empower them to make better-informed choices when they are shopping.”

Recommended Reading: California Senator Bob Wieckowski  & SB-504 Protecting Californians from Synthetic Food Dyes Act

February 22, 2017

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One ring to rule them all

The Food Foodnavigator brings our attention to a new GAO (Government Accountability Office) 52-page report  that reiterates the need to have a more coordinated and national approach to food safety.

In simple terms the report says the 19 agencies that manage food safety have improved coordination efforts but remain disjointed; and there is a need for “One ring to rule them all.”

The long winded version recommends the executive branch “…guide the nation’s efforts to improve the federal food safety oversight system and address ongoing fragmentation, we recommend that the appropriate entities within the EOP, in consultation with relevant federal agencies and other stakeholders, develop a national strategy that states the purpose of the strategy, establishes high-level sustained leadership, identifies resource requirements, monitors progress, and identifies short and long-term actions to improve the food safety oversight system.”

Food Navigator

Citing an uptick in multi-state foodborne illness outbreaks and their high cost to consumers and manufacturers alike, the Government Accountability Office reiterates its 40-year argument for a single, unified food safety system – this time under the Executive Office of the President.

February 17, 2017

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Confused by? Best by – Use by – Sell by

The Grocery manufacturers association (GMA) releases new industry guidance on Product Date Labels.


The new voluntary initiative streamlines the myriad date labels on consumer products packaging down to just two standard phrases. “BEST If Used By” describes product quality, where the product may not taste or perform as expected but is safe to use or consume. “USE By” applies to the few products that are highly perishable and/or have a food safety concern over time; these products should be consumed by the date listed on the package – and disposed of after that date.


Source: Grocery Industry Launches New Initiative to Reduce Consumer Confusion on Product Date Labels