January 21, 2018

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Planned Food Regulations for 2018

The Federal Government, publishes their Regulatory Agenda’s semi-annually. This Fall’s 2017 agenda has been published  January 12, 2018 Federal Register – “The agenda describes the regulatory and deregulatory actions that are under development or recently completed for each agency.” The complete agenda can be found on reginfo.gov.

For your convenience, KnowledgeBank is filtered the list, to show only regulations impacting the Food and Supplement Industry


Agency Agenda Stage of Rulemaking Title RIN
HHS/FDA Proposed Rule Stage Laboratory Accreditation for Analyses of Foods 0910-AH31
HHS/FDA Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH61
HHS/FDA Proposed Rule Stage Updating Public Information Regulations 0910-AH69
HHS/FDA Proposed Rule Stage Revision of Product Jurisdiction Regulations 0910-AH71
HHS/FDA Proposed Rule Stage The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules 0910-AH77
HHS/FDA Proposed Rule Stage Suspension of Registration of Food Facilities 0910-AH79
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
HHS/FDA Proposed Rule Stage Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size 0910-AH83
HHS/FDA Proposed Rule Stage Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AH89
HHS/FDA Proposed Rule Stage Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and E 0910-AH92
HHS/FDA Proposed Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E 0910-AH93
HHS/FDA Final Rule Stage Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
HHS/FDA Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
USDA/AMS Proposed Rule Stage National Bioengineered Food Disclosure Standard 0581-AD54
USDA/AMS Proposed Rule Stage NOP; National List Amendments, Proposed Rule 0581-AD60
USDA/AMS Proposed Rule Stage NOP: Organic Livestock and Poultry Practices 0581-AD75
USDA/AMS Final Rule Stage NOP; Organic Livestock and Poultry Practices 0581-AD44
USDA/FNS Final Rule Stage Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements 0584-AE53

January 19, 2018

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National Organics Standards Board – Substance Update January 2018

National Organic Standards Board (NOSB) is proposing to:

  1. change the use restrictions for seventeen substances allowed for organic production or handling on the National List:
    1. micronutrients; chlorhexidine; parasiticides; fenbendazole; moxidectin; xylazine; lidocaine; procaine; methionine; excipients; alginic acid; flavors; carnauba wax; chlorine; cellulose; colors; and, glycerin.
  2. add sixteen new substances on the National List to be allowed in organic production or handling:
    1. hypochlorous acid; magnesium oxide; squid byproducts; activated charcoal; calcium borogluconate; calcium propionate; injectable vitamins, minerals, and electrolytes; kaolin pectin; mineral oil; propylene glycol; acidified sodium chlorite; zinc sulfate; potassium lactate; and, sodium lactate.
  3. prohibit the botanical pesticide, rotenone, for organic crops

Source: Federal Register

For more background see the National Organic Program.

January 17, 2018

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FDA Extends comment period for Soy Protein and Coronary Heart Disease Health Claims

Background “In the Federal Register of October 31, 2017, FDA published a proposed rule to revoke our regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We proposed this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. We provided a 75-day comment period for the proposed rule.

We have received requests for a 60- day extension of the comment period for the proposed rule. Each request conveyed concern that the current comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the requests and is extending the comment period for the proposed rule until March 19, 2018. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.” source

See previous posting: Rest-in-peace: Loosing status “Soy” will no longer be heart healthy.

January 8, 2018

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Bioengineered Food Disclosure and Labeling – On Track for July this Year!

The GMO law is still on schedule!!!!

On July 29, 2016, congress mandated that USDA Agricultural Marketing Service (AMS) had until July 2018  to finalize the rules for a  National Bioengineered Food Disclosure Standard.

By any other name — its still the GMO — on December 26, 2017, the  regulations were sent to the Office of Management & Budget for review.

This graphic shows us where we are in the process:

The AMS posts updates on this proposed rule  on their GMO & Labeling webpage.


January 8, 2018

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New FDA Data Dashboard

The FDA gave us a New Year’s present – with a new Data Dashboard.  They have created a contemporary — wow! yes contemporary! — and aesthetically pleasing dashboard to display publicly available data.  The dashboard covers four areas, Inspections, Compliance Actions, Recalls and Imports/Import Refusals, with data from 2009 thru 2018. The data is broken into broad buckets,  Biologics, Drugs,  Devices, Food/Cosmetics, Tobacco, and Veterinary — unfortutely food, dietary supplements and cosmetic data is all lumped together.

  • FDA Inspection

    • Includes completed and finalized inspections of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. See also the FDA Inspections Database
  • Compliance Actions

    • Data pertaining to Warning Letters, Seizures, and Injunctions. The compliance actions disclosed include only finalized and completed actions and are primarily used in the domestic arena. Actions pertaining to foreign firms often take the form of import alerts, and are currently not reported in this Dashboard release.
    • Reminder, the FDA has archived many warning letters – searching FDA.gov site will not find archived letters please use the KnowledgeBank free tool to search for archived warning letters.
  • Recalls

  • Imports/Import Refusals.

    • Interestingly, the source of the import data is not clearly cited.


All in in all a great first step.





December 18, 2017

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Oregon Bottle Bill – Expands January 1st 2018

The Oregon Liquor Control Commission wants to remind consumers and retailers that additional beverages are being included in Oregon’s Bottle Bill and will have a refund value of 10 cents per container beginning January 1, 2018. This change came as the result of Oregon statute, ORS 459A.702.

Most beverages in bottles or cans that are sold in sealed glass, metal, and plastic in sizes from 4 ounces up to 1.5 liters will be included.

Some of the common beverages that will have a 10-cent refund value are:

Soda, beer, and water in sizes 3 liters or less will continue to have a refund value of 10 cents.

Beverages NOT included are:

OLCC has created resources for retailers and customers leading up to the transition.


For more information on Oregon’s Bottle Bill:

OLCC’s website: http://www.oregon.gov/OLCC/pages/bottle_bill.aspx

Sign up for email alerts: http://www.oregon.gov/OLCC/pages/bottle_bill.aspx#Subscribe_for_Bottle_Bill%C2%A0Updates

Email OLCC staff: OLCC.BottleBill@oregon.gov


For more information about Knowledge Bank’s “quick start guide” to U.S. Beverage Redemption laws contact Knowledge Bank


November 13, 2017

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Is Restaurant Labeling like a Diet Plan that Never Starts?

The FDA recently released its Draft Guidance for Industry: Menu Labeling Supplemental Guidance, which proudly and prominently sstates “Contains Nonbinding Recommendations. Draft – Not for Implementation.”  


Seems that the FDA isn’t too sure about the rule, and others have taken notice.


Veneble LLP, points out the Menu Labeling laws might never get implemented.  [Source: Will FDA Be Forced To Eat Menu Labeling?]  As we’ve previously reported (Menu-Labeling Regulations: Congressional Subcommittee June 9th, FDA Clarifies Menu Labeling Compliance DateRestaurant Nutrition Labeling Deadline Extended) The FDA has extended the deadline several times.  The latest deadline is May 7th, 2017 – some 2 years 5 months and 6 days after the original 2015 deadline.


The PDF guidance document, impressive at 36 pages, provides very nice graphics with samples as to how the new rules might be implemented at the point of sale. However, the Veneble article says, “If the [restaurant] material’s “primary purpose” is it to “entice” customers into the establishment, then, according to FDA’s guidance, it need not include calorie disclosures.”  But more importantly  “This approach stumbles quickly. A menu facing outward on a restaurant window is intended “primarily” to “entice” and to offer specific food items for sale.”


With “food menu labeling” and “food enticement labeling” being very much open to interpretation its obvious Veneble has it right when they say ” If and when restaurants…implement…menu labeling requirements and [the] FDA brings enforcement…there is enormous potential for a regulatory and litigation morass.”


As always, for legal advice please consult your attorney. Knowledge Bank does not provide legal advice. Knowledge Bank provides the food and dietary supplement industries with science,  nutrition and regulatory advisory services.  We provide “health checkups” for your labels. “

November 2, 2017

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Loosing status “Soy” will no longer be heart healthy.

On Oct 31st, the FDA announced a new proposed ruling, to revoke 21 CFR 101.82 ” Health claims: Soy protein and risk of coronary heart disease (CHD).”


The announcement is carefully worded and long winded, to say the FDA has the right to re-evaluate data, and revoke claims when the data no longer supports the claim.


The FDA certainly has to be careful since soy beans are  a multi-billion dollar industry, and the U.S. is the world’s leading producer [Source: USDA Soybeans and oil crops].


The FDA knows what its up against.  So its no wonder,  they take 20 pages to list in detail their position, and cite 230 bibliographic sources!!!


Its conjecture, but it seems like soy health two health  claims will be gone:


  1. 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.
  2. Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein.


Interested parties have until January 16, 2018 to submit written or electronic comments on the proposed rule.  Massive comments will certainly  delay the process, as the FDA compiles them and systematically responds to them.  But unless their is actual new research that hasn’t yet been published it seems unlikely the outcome will change.




November 2, 2017

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“Local” — “Naturally” the next big fight?

Kelley Drye & Warren LLP, “Ad Law Access” bring us an article “Local” Means Something, but What?


According to BakingBusiness, “A jury in the U.S. District Court for the District of Utah, Central Division, on Oct. 6 awarded Bimbo Bakeries USA $2,105,256 after determining the company suffered damages from trade secret misappropriation and false advertising.”


The lawsuit dates back to August 2013 — US Bakery’s Grandma Emilie’s bread was too similar to Bimbo Bakeries USA’s [BBU] Grandma Sycamore’s bread. US Bakery had acquired the Grandma Emilie’s brand as part of its acquisition of certain assets of Hostess Brands, Inc.” BBU filed suit for trademark infringement, trade secrets misappropriation, false designation of origin, and false advertising.


Although the $2.1M award covers many areas, the suit alleged “the US Bakery’s “Fresh. Local. Quality.” tagline was false in Utah because U.S. Bakery neither maintained a baking facility in Utah nor contracted with a Utah facility to manufacture its products.” [Baking Business]


“The jury attributed over $8 million in profits to the false advertising and awarded over $2 million in total damages (including the trade secret claims). Because the Special Verdict form simply asked for “Yes” or “No” responses, we don’t have any insights into the analysis or a clear answer as to what “local” means.” [Ad Law Access]


In other words, “Local” joins “Natural” and other ill defined words, fully exposed for to private lawsuits.

October 24, 2017

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Stay Alert to Wrigley’s relaunch of Caffeinated Alert Gum

Perhaps you have seen the news:


After 4 years, caffeinated gum relaunches to the public.  Certainly the military dispenses caffeinated gum to its troops, but health risks and concerns are yet to be tested.  Cleary with the FDA on the sidelines and without a formal guidance, Mars Wrigley is taking a calculated risk.


The FDA through policy and regulation, has defined “Energy” as coming from  “carbs, fats, and protein.”  Consumers of central nervous system stimulants like caffeine, experience effects as a boost in  “energy”.


More over caffeinated gum that “confers energy to a human” enters the grey area, and becomes a questionable structure/function claim. This is a particularly interesting situation for FDA enforcement because gum is not a significant source of carbs, fats or proteins.


In all cases, develop your business strategy first, and consider all the risks.  For most companies without the Mars Wrigley resources,  we expect them to choose a  “wait and see what happens strategy.”  Only for the most fearless entrepreneurs with absolutely nothing to loose (i.e. no existing brand, not sales, no reputation) might try and carve out a small niche, and even then you might ask why enter a market that’s decreasing 4% a year. [“U.S. gum sales declined 4% in the first half of 2017, according to IRI data reported by Food Navigator-USA. While Wrigley dominates the category by a wide margin — owning 72% share”]