September 15, 2017

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The Scott Gottlieb Ooops Tweet

Dr. Scott Gottlieb, the new FDA head, is creating confusion about the UPDATED Nutrition Facts compliance date.

 

Food Navigator broke the story and well worth the read.

 

He spoke at a politico summit and suggested one date…then tweeted a different date.  Once the date is officially published in the Federal Register, then we will have a new target.Scott Gottlieb, The 23rd Commissioner of the U.S. Food and Drug Administration, tweeted an oops.

….this hour’s thinking is that the new date is 18 months out….mid-2019.

This would likely coincide with the required disclosure of genetically engineered ingredient content on foods and supplements.

Knowledge Bank’s next courses for labeling and Nutrition Facts update are next week! http://knowledge-bank.net/training/

 

The key takeaway  — “TWEETS” are like “water cooler” gossip.    Tweets and stories must be carefully considered and suspect until proven otherwise.  Tweets are not “legal” announcements of regulations.  The Federal Register remains the only way a regulation can become official.  Even the eCFR (Electronic Code of Federal Regulations) states “It is not an official legal edition of the CFR.”  Only the printed Federal Register remains the official mechanism.

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.


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 Reginfo.gov 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

USDA

  • 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

  • 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

 

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: