July 17, 2018

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Don’t slip up! FDA Warning Letter Scam

The FDA recently posted FDA warns of imposters sending consumers fake warning letters.  “While warning letters are a common compliance tool used by the FDA, we typically send them directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products,” said FDA Commissioner Scott Gottlieb, M.D. “Consumers who aren’t involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it’s probably fake, and probably a scam.” Full Posting

Remember – Warning letters are given to manufactures, distributors and others who are part of the supply chain for the manufacture and sale of FDA regulated products – Foods, Dietary Supplements, Medical Devices, Drugs, Vaccines and Biologics.

Current warning letters (2013 to present day) are published on the FDA’s website.  Older warning letters (2005-2012) have been archived and are no longer available or searchable on the FDA’s website. Knowledge Bank has made archived warning letters available and searchable from the Google search bar at www.fdalabelcompliance.com.

 

 

June 28, 2018

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Want healthier foods? Let the FDA Know

 

FDA Announces Public Meeting to Discuss Nutrition Innovation Strategy Implementation

Full posting available here

June 26, 2018

The U.S. Food and Drug Administration announced today a public meeting to discuss the agency’s Nutrition Innovation Strategy. In a statement released today, Commissioner Scott Gottlieb, M.D., emphasized that the public meeting will begin an important dialogue on various aspects of the strategy with a variety of stakeholders. In his March 29 speech to the National Food Policy Conference, the Commissioner recognized the critical role the FDA plays in protecting public health through improvements to the nutritional profile of foods that compose the American diet. He stated that developing strategies to improve nutrition can be a transformative step toward reducing the burden of many chronic diseases, ranging from diabetes to certain cancers to heart disease. As such, the FDA is hosting a public meeting to give interested parties an opportunity to discuss various features of the FDA’s Nutrition Innovation Strategy, which promotes public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease.

Since announcing the Strategy earlier this year, the FDA has identified several areas where it believes there are opportunities to improve FDA’s approach to nutrition policy, by encouraging industry innovation to improve the nutrition and healthfulness of food and by providing consumers with informative food labeling to make healthy food choices. These tactics include developing a standard icon or symbol for the claim “healthy;” a more efficient review strategy for the FDA to employ when evaluating qualified health claims; allowing for labeling statements or claims on food products that could facilitate innovation to promote healthful eating patterns; approaches for modernizing standards of identity; possible changes that could make ingredient information more consumer friendly; and implementing the FDA’s educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace.

The meeting will be held on July 26 from 8:30 a.m. until 5:30 p.m. at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852 and include introductory presentations, panels, oral presentations by participants as well as breakout sessions. Public meeting attendees are encouraged to register online to attend the meeting in person and via live webcast.

June 15, 2018

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The FDA Approved Dietary Fiber list gets fatter with 8 new additions.

Sorry for the pun, but sometimes you just need to make a dry fibrous topic a little more fun and chewy…

The FDA added 8 new dietary fiber to their approved list.  The details can be found FDA Issues Guidance, Science Review, and Citizen Petition Responses on Dietary Fiber (14 Jun 2018).

New dietary fibers

  1. mixed plant cell wall fibers
    • a broad category that includes fibers like sugar cane fiber and apple fiber, among many others
  2. arabinoxylan
  3. alginate
  4. inulin and inulin-type fructans
  5. high amylose starch (resistant starch 2)
  6. galactooligosaccharide
  7. polydextrose
  8. resistant maltodextrin/dextrin

Previously approved dietary fibers:

  1. [beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A));
  2. Psyllium husk (as described in § 101.81(c)(2)(ii)(B));
  3. Cellulose;
  4. Guar gum;
  5. Pectin;
  6. Locust bean gum;
  7. Hydroxypropylmethylcellulose.

 

For Additional Information:

May 18, 2018

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Ignoring Partially Hydrogenated Oils (PHOs) could be dangerous to your business. Smile, the FDA “might” have given you more time to be a hero!

Back in 2015, partially hydrogenated oils (PHOs) were ruled unsafe for human consumption. The FDA’s original final decision can be found here. The deadline for removing PHOs, for the vast majority, remains June 18th 2018 — just 30 days away!

 

But today the FDA announced — “FDA Extends Compliance Date for Certain Uses of Partially Hydrogenated Oils in Food; Denies Petition for Certain Uses of PHOs

 

“For the majority of uses of PHOs, June 18, 2018 remains the date after which manufacturers cannot add PHOs to foods. However, to allow for an orderly transition in the marketplace, the FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. The FDA is extending the compliance date for these foods to January 1, 2020. This action balances the health benefits of removing PHOs from the food supply with the need to provide an orderly transition in the marketplace.”

 

“At the same time, the FDA is denying a food additive petition from the Grocery Manufacturers Association (GMA) requesting approval for certain limited uses of PHOs. To allow for time for reformulation, the agency is extending until June 18, 2019 the compliance date to stop manufacturing foods with these specific, limited petitioned uses of PHOs, and until Jan. 1, 2021 for these products to work their way through distribution.”

 

“For convenience, FDA is summarizing the extended compliance dates as follows:

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021

May 9, 2018

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FDA formally sets Nutrition Facts & Supplement Facts compliance date of 1/1/2020

May 4, 2018, the FDA has announced:

 

U.S. Food and Drug Administration formalized the new compliance deadline to update the Nutrition Facts and Supplement Facts labels as January 1, 2020 for large manufacturers (and January 1, 2021 for small manufacturers). On that date, all labels must be applied to retail food and dietary supplement packages with the most recent regulatory updates for nutrition values and formats. The original compliance date was July 26, 2018 (or 2019) which was two years after the regulations were announced on May 26, 2016. [Hence the confusion whether the “new” regulations are 2016 or 2018 “versions”!] The extension had been mentioned by FDA but not formalized until now. “Large” manufacturers is set by FDA as those with $10 million or more in annual (global) food sales while “small” manufacturers means those with less than $10 million in annual food (global) sales. The agency published a proposed rule

 

The approximately 18-month extension is to help companies gather more information and to provide sufficient time to also add the required label disclosure of genetically engineered content announced today by the USDA. The transition will take many person-hours to adapt to the new reference serving sizes, document added sugar content, reformulate if manufacturers want to keep fiber claims, and a host of other formatting changes that the software databases have not accommodated.

 

The FDA is also committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates. A full list of Nutrition Facts-related guidance documents is available on the FDA website.

For Additional Information:

April 30, 2018

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If you milk a plant, is it still milk?

Food Navigator alerts us to the FDA commissioner Dr. Scott Gottlieb presenting before a recent Senate Appropriations Committee, in which Wisconsin Senator Tammy Baldwin introduced the Dairy Pride Act.

 

  • In short, the Gottlieb, says the FDA hasn’t enforced the term “milk” and “yogurt”, and consequently there are many plant-based alternatives in the market now.
  • The FDA will “actively look” into the matter, but reversing policy course has many repercussions, so they will look into the matter with care.

 

In other words the FDA didn’t bow down to the Senator. In looking at these situations, I often remind myself that the FDA’s charter primarily focuses on managing public safety risk.  Ensuring Fair Trade is generally the domain of the Federal Trade Commission.

 

The FDA and FTC work together, but the questions that need to be worked out are: Is the consumer at risk? Is the consumer harmed? Can the consumer tell the difference between a “plant based protein milk” and  “bovine milk.?” Is there a commercial unfairness?  I don’t know the answers to these questions?

 

According to Statista California is the leading cow’s milk producer and Wisconsin is second.  So why isn’t the California and Wisconsin Senators co-authors of the bill? I wonder if it has to do with Silicon Valley spending millions on plant based startups?

 

Food Navitator: FDA commissioner weighs into plant-based ‘milk’ debate

FDA commissioner Dr Scott Gottlieb says the agency is “actively” exploring whether consumers are being misled by the use of terms such as ‘milk’ or ‘yogurt’ to describe plant based products, but says the FDA’s radio silence on this issue in recent years may make it harder to take action now without new data.

April 16, 2018

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Caffeinated Dietary Supplements on the FDA High Risk Radar Screen

Dear Colleagues

Forwarding FDA news about caffeine—which can apply to caffeine derived from green tea.  Immediate concern is any bulk sales of caffeinated supplements directly to consumers that are not “pre-measured” to control dosing (including products measured with a “scoop”).

“The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk.”

PDF of guidance is here https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf

Assuming that the product otherwise complies with all applicable legal requirements, we do not expect to consider the following types of dietary supplements to be adulterated:

  1. Dietary supplements sold in solid dosage forms, such as tablets or capsules that do not provide an excessive amount of caffeine per item. Products in these forms eliminate the need for a consumer to accurately measure the appropriate serving.
  2. Dietary supplements containing powdered or liquid caffeine (either diluted or undiluted) that are sold in premeasured packets or containers, with each premeasured unit containing an amount of caffeine that is not excessive. Products that are sold in pre-measured quantities eliminate the need for a consumer to measure the appropriate amount.
  3. Bulk powdered or liquid caffeine dietary supplement products that have been significantly diluted to low enough concentrations of caffeine, such that a reasonably foreseeable measurement error, misreading of the directions, or misunderstanding about the nature of the product would not normally be expected to lead to toxic or life-threatening symptoms.

All dietary supplements are required to comply with the adulteration provisions of the FD&C Act, and we intend to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form.

Thankyou Debra Topham

April 2, 2018

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Gottlieb speaks. Healthy, Qualified Claims, Allergies and overall Nutrition in Focus

As reported in several places, after what some consider two-years of radio silence, Scott Gottlieb, FDA Commissioner,  addressed the Consumer Federation of America’s National Food Policy Conference in Washington DC March on 30th 2018, with a speech outlining broad changes to FDA food policy. The full video and text transcription is available on CSPAN here

 

From opening about heart disease and cancer, Mr. Gottlieb quickly reminds us that  “we can’t lose sight of the public health basics like better diet, more exercise and smoking prevention and cessation.”

 

He goes on to say ” We know today people are eating too much food fighting to make cases there still a consuming enough of certain nutrients to achieve a balanced diet.  We’re keeping all of these considerations in mind as we pursue making an update to the definition of healthy.”

 

“We will also consider how to depict healthy on the package so that consumers can easily identify it, particularly when they may not have time or the skills exam all the information on the food package. To address this we’ve had discussions about whether there should be a standard icon or symbol for the word healthy that everyone could use on food packages”

 

“We also plan to seek input on other possible changes to our nutrient content claims ……we are also interested in exploring claims are products that offer food groups which american dies typically fall short of the current recommendations; For example, whole grains, low-fat dairy, fruits and vegetables and healthy oils.”

 

“[We want]..streamlined process for reviewing qualified health claims we receive from the industry … We need to consider how to enhance the…review process. For instance, we want to be able to triage those requests according to public health significance and to prioritize the review of those that are most meaningful and most science-based. One such example…use qualified health claims linking early peanut introduction to reduce risk of developing peanut allergy.”

 

“Our intention is to prioritize those qualified health claims in the most likely to have a health benefit and data based on the strongest science…”

 

Additional resources:

 

March 1, 2018

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New FDA Guidance – March 1, 2018

FDA has posted new guidance to help the US food and supplement businesses with compliance to the updated nutrition label regulations.  The final rule was issued May 2016 and was to become enforced July 2018 (or 2019).  The announcement is available here.

 

An extension to the deadline was proposed by the FDA. The new deadline was to be January 2020 (or 2021). We’ll have to continue to wait until “Spring 2018” for a firm and final rule on when the packaged foods and supplements will be enforced for proper nutrition labels.

While we are waiting, there is plenty of new help for the industry posted today (March 1, 2018) on these topics:

  1. Serving sizes
  2. Added sugar in honey, maple syrup and cranberry products
  3. What FDA will use as a ruler when examining a “synthetic non-digestible carb”—but no specific answers on the synthetics currently submitted for consideration

On April 26, 2018, Knowledge Bank is partnering with California Polytechnic University in Pomona, CA for a basic label training course. Check back for more details on this one-day course.

February 20, 2018

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Warning Letter Lessons for Dietary Supplements

The FDA recently issued a warning letter to a dietary supplement company;  KnowledgeBank has always recommended food and supplement companies read warning letters to gain understanding into the regulations and how the FDA approaches such situations.

Remember there are many more FDA inspections, than warning letters.   Letters result when issues do not get addressed adequately and promptly.  This particular warning letter was issued  more than 90-days after the companies original response. The letter covered three broad categories:

  1. Unapproved New Drugs
  2. Adulterated Dietary Supplements
  3. Misbranded Dietary Supplement.

Unapproved New Drugs:

As you read the letter its clear the Unapproved Drug claims are the most egregious issue — the FDA list reasons why they found the supplement was a drug:

“Examples of some of the claims that provide evidence that your product is intended for use as a drug include the following:”

  • “Chinese medicine ….”
  • “[H]as been used in Traditional Chinese Medicine for thousands of years ….”
  • “[B]ees use propolis to protect themselves from bacteria and diseases. Propolis has been around for over 40 million years and has been used by man for thousands of years ….”
  • “Propolis … contains more than 30 different flavonoids and antioxidants to help control free radicals. Free radicals are caused by waste from our body cells that increase with … infections … and toxins. The antioxidants help to neutralize the free radicals and prevent cell damage.”

Adulterated Dietary Supplement:

The FDA broadly outlines the meaning of “adulterated dietary supplement..[a] product has been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).”

They then go on the provide the specific reason why the product was adulterated:  “As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution

Finally the FDA provide examples as to how the distributor’s procedures (such as failure to open the incoming packages) could not possibly allow the distributor to  make informed decisions about their product.

“your written procedures for quality control operations do not include quality control functions such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications.”

“your firm must collect reserve samples for each lot of packaged and labeled dietary supplements that you distribute, and hold the samples in accordance with 21 CFR 111.83(b)”

“You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503”

Misbranded Dietary Supplement:

Misbranding boils down to errors on the label itself.

  • Not labeling parts of the plant:
    • “the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
  • Incorrect or inconsistent serving size:
    • “Take 1 capsule twice daily,” but the serving size lists “2” capsules.
  • Not recognizing some words like “Good” or “Rich” have regulatory meanings:
    • “Propolis is a rich source of minerals, vitamins C, E, provitamin A, and B-Complex ….” To bear “rich in” claims, a product must contain 20% or more of the RDI or DRV of the nutrients that are the subject of the claim, in accordance with 21 CFR 101.54(c)