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).
For Additional Information:
In case you missed it, we thought we’d share some photos…. contact us a ‘clientservices at knowledge-bank.net’ if you’d like training on-stie at your business.
For the full press release see: http://www.cpp.edu/~agri/news/2018-food-labeling-workshop.shtml
—Scheduled for April 26, 2018 AND HOSTED BY the Don B. Huntley College of Agriculture at Cal Poly Pomona (California)
To register visit: www.cpplabel.eventbrite.com
Too many food companies find out there IS a labeling regulation when they are first threatened by a lawsuit or notified of regulatory agency action. Get the bare bones of USA food label regulations in this 7-hour workshop hosted by Cal Poly Pomona. This beginning workshop is for those new to what must appear on a food label. The workshop is intended for food industry professionals, agri-business faculty, entrepreneurs, registered dietitians, food science & food-related business students.
The practical tools and examples will help attendees create a skeleton of the 7-basic label elements. Take the fright out of how to declare “added sugars”, “additives”, and “dietary fibers” when transforming labels before the new nutrition facts deadline of July 2018. The workshop will demonstrate where to find the rules, calculations, and disclosures for the basic “packed with” or “free from” nutrient claims.
Save the date: Thursday, April 26, 2018 at Agriscapes at Cal Poly Pomona. Visit www.cpplabel.eventbrite.com for upcoming information and registration details. Continuing Education Units/Contact Hours have been applied for through the International Food Science Certification Commission (IFSCC) for certified food scientists and Academy of Nutrition & Dietetics.
Debra KW Topham, MS, CNS, CFS, Director of knowledge bank
Debra is director at Knowledge Bank. Her boutique consulting firm provides “health checkups” for USA food and supplement labels as well as substantiation reports for ingredient claims. The Huntington Beach, CA consulting service checks that USA product labels & sell sheets including nutrient and health claims are in compliance with FDA, USDA, and FTC regulations. Debra is a 35-year veteran of the food industry with experience reviewing more than 3,000 product labels for her clients and Fresh&Easy Neighborhood Market and soon the software launch of ReviewQ®. She is a Certified Nutrition Specialist and Certified Food Scientist and adjunct lecturer for local universities.
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:
|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|
|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 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:
The United States Department of Agriculture released its proposed rules for declaring “bio-engineered food ingredient” content on most foods that are not organically certified. The required disclosure will a federally mandated message rather than a warning, as is the case of with high risk products.
Industry and consumers only have until July 3, 2018 to make comments to the proposed rules–with no hope of an extension. USDA has set compliance dates to coincide with the FDA’s new nutrition facts and supplement facts label updates: January 1, 2020 (or 2021 for small manufacturers).
Comments are requested by the USDA regarding which disclosures are most suitable and if “TWO pre-approved lists of agricultural crops” make the most practical sense for designation of “b-e” foods and “b-e” food ingredients. The lists would be updated periodically and USDA is seeking comments on this practicality, too.
Comments may be submitted online through the Federal eRulemaking portal www.regulations.gov beginning Friday May 4. Comments may also be filed with the Docket Clerk, 1400 Independence Ave., SW, Room 4543-South, Washington, DC 20250; Fax: (202) 690-0338.
The deadline for comments is July 3, 2018.
The USDA is proposing disclosures on packages –similar to the National Organic Program regulations–in the form of:
The disclosure will not use the popular terms “Genetically Modified Organism” or “GMO”. Rather the USDA believes “bio-engineered” is a more realistic term to comply to the law signed in 2016. This was the federal law enacted to avert a state-by-state patchwork of GMO-labeling laws.
The National Bioengineered Food Disclosure Standard Law was enacted by Congress on July 29, 2016. The proposed rule previewed in the May 3, Federal Register.
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 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?
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.”
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:
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
Hyman Phelps MacNamara PC’s LawBlog brings us this news “Agency Publishes Final Guidance on Data Integrity – the British Medicines and Healthcare Products Regulatory Agency that is”
As the article points out, the FDA draft guidance was published two years ago. The British [or more formally the British Medicines and Healthcare Products Regulatory Agency (MHRA)] beat the FDA and published a guidance on “GXP Data Integrity.” Even though the FDA has yet to finalize its guidance I’m sure someone at the FDA has been tasked to read what the British wrote, so we should too.
The LawBlog does a good job summing up the data integrity principals which I’ll further summarize.
Knowledge Bank is NOT a legal firm; The materials available at this web site are for informational purposes only. Please consult with an attorney for all legal matters.
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…”