Posts Tagged ‘fda’

Bimbo, industry wait on F.D.A. rulings

March 17th, 2018

Bakers and their ingredient suppliers, eager to put adjustment plans in place, are waiting on new Food and Drug Administration rulings. The F.D.A. has yet to finalize a compliance date for its new Nutrition Facts Panel, and it has yet to rule on whether certain ingredients, including inulin, meet the agency’s definition of dietary fiber.

“The biggest challenge I think that we face, not only at B.B.U. but industry wide, is the indecisiveness of F.D.A,” said Phil Boehm, director of regulatory affairs for Bimbo Bakeries USA, in a panel discussion Feb. 27 in Chicago at the American Society of Baking’s BakingTech 2018

The lack of clarity around dietary fiber might be the biggest regulatory issue, said Brook Carson, vice-president of product development and marketing for Manildra Group USA, an ingredient supplier based in Leawood, Kas.

“I would say the lack of clarity prevents the opportunity for new fibers to come to the market and the opportunity for new innovation from bakers,” she said.

The F.D.A. in the May 27, 2016, edition of the Federal Register defined fiber for the first time. Ingredients may qualify as fiber if they are non-digestible carbohydrates (with three or more monomeric units) and lignin that are intrinsic and intact in plants. Isolated and synthetic non-digestible carbohydrates (with three or more monomeric units) also may qualify if they are the subject of an authorized health claim or if the F.D.A. rules in favor of a citizen petition. The F.D.A. has yet to rule on 12 petitions on 9 different potential fibers.

B.B.U., part of Grupo Bimbo S.A.B. de C.V. and based in Horsham, Pa., has taken a wait-and-see approach to product reformulation involving fiber, Mr. Boehm said. Research and development efforts instead are focusing on such areas as clean label and removing high-fructose corn syrup. Research and development centering on fiber could increase “dramatically” whenever the F.D.A. rules on the petitions on potential fibers, he said.

Scott Gottlieb, M.D., commissioner of the F.D.A., addressed fiber in a March 1 statement about the Nutrition Facts Panel.

“The F.D.A. has been evaluating data submitted to us from the food industry in petitions on various non-digestible carbohydrates and will communicate our decisions on these petitions soon,” he said.

The F.D.A. also issued final guidance that contains more evidence the F.D.A. is looking for on various non-digestible carbohydrates when deciding whether they count as fiber. The guidance may be found here.

The compliance date

The food industry began preparing for the new Nutrition Facts Panel when the F.D.A. unveiled it in May 2016, Mr. Boehm said. The original compliance date was July 26, 2018. Then in September 2017, the F.D.A. proposed to extend the compliance date. Under the proposal, manufacturers with $10 million or more in annual food sales would have until Jan. 1, 2020, to come into compliance, and manufacturers with less than $10 million in annual food sales would have until Jan. 1, 2021.

Now, companies are placing less emphasis on the Nutrition Facts Panel changes since they should have a longer time to comply, Mr. Boehm said.

“It kind of fell by the wayside a little bit,” Mr. Boehm said. “You can take the indecisiveness not only for the compliance date but for the definition of dietary fiber, what we’re doing with added sugar, and the list goes on and on from an F.D.A indecisiveness point of view. So I think the biggest challenge we have is trying to get our head around what’s the dates, what do we need to do and when do we need to do it.”

Dan Herzog, vice-president of corporate compliance and food safety for Gonnella Baking Co., said F.D.A. inaction was creating “turmoil” in the baking industry.

“It’s just amazing at the amount of change that could come through (following F.D.A. rulings),” he said. “One of the biggest challenges that we see out there is the fact that we don’t understand everything that is coming from the F.D.A. We don’t know the dates.”

Schaumburg, Ill.-based Gonnella Baking Co. is keeping its labeling and packaging inventory as low as possible until the F.D.A. finalizes the compliance date for the Nutrition Facts Panel, he said.

Mr. Boehm said B.B.U., like Gonnella Baking, is keeping inventories at a minimum.

“We’ve already converted probably about two-thirds of our packaging right now because we have been working on it since 2016,” Mr. Boehm said.

Dr. Gottlieb in his March 1 statement said the F.D.A. this spring will issue a final rule.

What’s next in labeling?

The panelists were asked what labeling regulatory issues will become paramount after attention fades on the Nutrition Facts Panel issue.

Mr. Boehm said he expects G.M.O. labeling to come to the forefront. Mr. Herzog said G.M.O. labeling, and he also mentioned possible effects from California’s Proposition 65 situation.

Jacinte Côté, Ph.D., product management director for Montreal-based Lallemand, said regulation on front-of-pack labeling could become a priority. The issue already has affected Brazil, Chile, France and the United Kingdom. She gave sodium content on the front of packaging as an example.

“I don’t think it’s going to be very positive,” Dr. Côté said. “It’s going to be like warnings.”



Companies ,

Are you ready for FSMA?

July 1st, 2017
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Armed with clipboards, swabs and a keen eye, the Food and Drug Administration (FDA) has slowly begun assessing bakery operations across the country. Under the Food Safety Modernization Act (FSMA), baking facilities will undergo inspections verifying that preventive controls are in place. And while being prepared for an unannounced inspection is at the top of many companies’ agendas, what should they expect when the investigators walk through the door?

Shawn Stevens, FDA consultant and attorney at FoodIndustry Counsel, LLC, said there are five enforcement priorities for the agency. These include critical review of food safety plans and verification records, extensive microbiological sampling, recall requirements for samples that test positive for pathogens exceeding FDA thresholds, comparing pathogens found in the facility against human isolates stored in the Centers for Disease Control’s PulseNet database, and initiating broader investigations — including criminal — of food companies whose products are found to have caused human illness.

With this in mind, bakers must ensure their records are up-to-date, staff is properly trained and preventive controls are established, all before investigators arrive.

For the record

Under FSMA, a company’s food safety plan should have been established in September 2016, but many bakeries are still struggling to develop an effective document that encapsulates its approach to identifying food safety hazards. It’s even harder to establish one that can be updated easily. Many facilities are creating overcomplicated plans, leaving room for questions they may not be able to answer during an inspection.

Len Heflich, former co-chair of the American Bakers Association (ABA)’s Food Technical Regulatory Affairs Committee (FTRAC) and current president of The Center for Food Integrity, witnessed this pattern within the field.

“The industry doesn’t grasp the concept of a food safety plan because FDA doesn’t spell it out — and we don’t want them to,” Mr. Heflich said. “We want to take the lead on this and define it ourselves.”

So, Mr. Heflich developed a model for food safety plans, which he shared with ABA members. The two-page report outlines the policies and programs that a facility should have in place and contains brief information about them. The policy and program specifications are then detailed in a separate document specific to plant processes and products. This model allows baking companies to break down the plan and detail how they manage, control and minimize risk.

Plant operators must also remember to update plans accordingly. In the report, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” the FDA expressed the plan must be reanalyzed at least every three years. This includes when changes are made to systems or equipment, when new information is discovered about potential hazards associated with the food or facility, when there is an unanticipated food safety problem, or when a preventive control, combination of preventive controls — or the plan itself — is ineffective.

“It’s an evergreen document and process,” said Rasma Zvaners, vice-president of regulatory and technical services at the ABA. “If you change something in your operations, revisit your food safety plan and update it accordingly. The food safety plan should not live on the bookshelf collecting dust.”

One of the biggest changes resulting from FSMA is the role recordkeeping will play in day-to-day operations and during inspections. Documentation is required to confirm that actions such as monitoring, verification, validation and more have taken place in the facility.

“In the age of FSMA, your records become the face of your company,” said Elizabeth Fawell, counsel at Hogan Lovells. “It is how you show FDA you are doing a good job, not just when the investigator is in the facility but also day in and day out. That’s why we continually advise people, ‘If it isn’t documented, it didn’t happen. And if it is documented, it happened just that way.’”

To ease the recordkeeping process, it is in a food manufacturer’s best interest to standardize the plan while allowing for specific details. This includes creating a method of documentation with the same format among forms while still recording all the necessary information. An area should also be designated for documents to be stored for easy access. Finally, a system should be in place that verifies documentation is completed clearly, as to avoid any gaps.

Karl Thorson, food safety and sanitation manager, General Mills, Inc., Minneapolis, advised food processors to avoid creating overly complex procedures they will not follow through with.

“Trust but verify,” Mr. Thorson said. “Trust that your employees are doing it correctly but also have a program in place to check on them once in a while to make sure it was getting done right.”

Is your team ready?

 Participating in a mock inspection can be an effective method to determine whether your team is prepared for an unannounced inspection. AIB International’s latest field service, FDA Preparedness Inspection, simulates a FSMA-type investigation and determines if a facility’s regulatory policy is in line with requirements, if employees understand their company’s policy for handling regulatory inspections and if its food safety plan meets requirements.

Alicia Pulings, quality compliance manager at Schaumburg, Ill.-based Gonnella Baking Co., set up one of AIB’s FDA Preparedness Inspection knowing there were minor gaps in the facility’s FSMA compliance process but still confident in her group’s abilities. With the exception of two key decision-makers, the visit was unannounced to its staff, including the plant manager.

“Even though it was a test inspection, I could sense our team’s uneasiness, and it reminded them that we need to be audit-ready at all times,” Ms. Pulings said.

When an AIB inspector began collecting swabs at the Gonnella plant, it was a big reveal for the staff. Ms. Pulings believed this was an eye-opener for employees, especially those who did not attend a FSMA training.

“Knowing FDA could collect swabs is new and important,” Ms. Pulings said. “We needed minor revisions to a few of our existing programs. During the inspection, we learned that FDA has granted an extension to one of our new programs that are in the process of being implemented — without this simulated inspection, we would not have known.”

Making sure an operation’s team also understands how to interact with investigators is crucial, as any of them can be pulled aside at any moment to discuss procedures in detail or to pull records. This may entail taking extra time to train employees on methodologies and educating them on the reasoning behind it.

“If people are going to do their job well, they have to understand why they’re doing it,” Mr. Thorson said. “We’ve got to do better at explaining processes. Whether it’s the employee on the floor operating and cleaning the line or the engineer building the system, everyone has to understand why we have the expectations we do: ‘Why do I need to clean to this level? Why are you swabbing it with that swab?’”

What to expect

Being prepared for an inspection means more than having preventive controls in place. Such preparation includes mapping out a process for when investigators arrive and understanding the actions they will take while conducting the inspection. In his checklist, Mr. Stevens outlined how operators can effectively navigate the process from beginning to end and appropriately respond to any FDA criticisms once the site visit concludes.

Before the inspection begins, Mr. Stevens advised teams determine which members will interact with FDA investigators, revisit where critical documents are stored and organized, and review topics employees can discuss with the agency. To ensure all measures are in place, perform a mock audit that includes all staff performing their specified roles. Undergoing this practice will help employees feel confident when interacting with investigators.

When FDA representatives arrive, they will ask to conduct an entrance meeting to detail how they plan to conduct the inspection, how long they anticipate it will last and the specific tasks they intend to accomplish. These typically include a facility inspection, records review and “swab-a-thon.”

During the inspection, the agent will tour the production, packing, distribution and storage locations searching for physical deficiencies and sanitation violations and conditions that allow bacteria to grow. Throughout the process, the investigator should be accompanied by a designated guide to observe and immediately document and respond to any concerns.

At the time of the records review, the FDA will have wide access to most documents within the organization. However, the agency is not entitled to review or copy any recipes or data pertaining to finances, pricing, research, sales or personnel, other than to ensure that the company’s employees have received training appropriate to their position and responsibilities. If the FDA requests copies of any records the company deems confidential, be sure to mark those records accordingly.

Once investigators enter the plant floor, they will collect approximately 100 to 200 microbiological samples from incoming ingredients, outgoing finished products and various environments within the facility. Staff charged with accompanying the inspection should carefully document the areas where samples are being collected. If any samples are positive, this information will be critical to determine the most appropriate response.

If the FDA collects finished product or processing line samples to test for the presence of Listeria MonocytogenesSalmonella or any other pathogens, that facility should hold back any products made from the same lot or batch until the results come back. If any are positive, and the product has been held, a recall will not be issued.

Once the inspection is complete, the investigator will conduct an exit interview and share the findings. If violations have been identified, the agency personnel will issue a Form 483, which details the specific issues. Although not required by law, a company is generally expected to provide a written response with the appropriate documentation within 15 business days. The FDA will not pursue further regulatory action if the response adequately addresses the agency’s concerns.

In some cases, the investigator may ask the company to consider a recall of certain products. Any recall decisions — and whether to announce it — should be made very carefully and only after consultation with legal counsel. Mr. Stevens noted that many companies have successfully convinced the FDA, based on the availability of supporting facts, forensic analysis and scientific data, that a recall is not needed or that the scope can be significantly limited.

A reflective approach

As inspections come and go, they create opportunities for the industry to unite and learn from one another’s triumphs and mistakes. Mr. Heflich noted that food safety should not be a competitive process. Fostering discussions amongst companies builds confidence within the field and may provide insights the FDA can use to modify guidelines and protocols.

Industry groups already have expressed interest in creating guidance documents on FSMA requirements with two goals in mind: providing a valuable resource for their members and developing industry standards that can become part of FDA guidance in the future. The agency laid out steps for industry associations interested in developing food guidance documents and stated it would provide technical advice and check for potential conflicts with federal regulations.

“FDA has listened to a lot of what we asked for,” Mr. Heflich said. “We asked to keep it simple, not prescriptive; tell us what we need to do but not how to do it. The industry needs the flexibility and the ownership.”

With that in mind, he urged bakers to get involved with industry associations and discuss issues with peers and competitors to ensure that the industry can guide and define regulations and protocols set forth by the FDA.



Food Safety ,

Food safety insecurity used as a hook against regulatory reform

April 15th, 2017
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Each side has just the congressional recess left to practice its hyperbole for the coming Senate fight over how regulations will be used across government. It’s going to get nasty. And confusing. The practice of giving the other side’s bill a dirty name is now a common tactic.

Since the Regulatory Accountability Act passed the House by a vote of 238-to-183 in January, the collection of consumer and environmental groups opposing the bill have taken to calling it the “Filthy Food Act.”

It’s far from certain, however, that the new Regulatory Accountability Act would translate  into  weakened federal food safety standards.  It is, after all, about how new regulations might be imposed, not about changes to any of the 47,661 rules put in place since 2001, including 1,062 “major new rules” that each cost the economy $100 million or more each year.

Since the 1970s, agencies have had to keep track of the costs and benefits of regulations and Government Accountability Office dutifully keeps track of all the data, which is a said to impose $2 trillion a year on the economy.

The new Regulatory Accounting Act would  put agencies through more hoops in the regulatory process.  More were added the 1980s, but it’s hard to say that slowed the process.   Congress likes leaving the details to the agencies.

The new Regulatory Accounting Act calls for more attention to the economic impact on small business, and calls for indirect and cumulative impacts of new regulation to be taken into account when new regulations are being proposed.

Agencies promulgating rules would be required to come up with alternatives to proposed rules to minimize any adverse economic impact or maximize any beneficially significant economic impact on small entities. The Bureau of Land Management (BLM) and the U.S. Forest Service, the agency landlords for most of the 640 million acres owned by the U.S. government,  are required to generate business –friendly alternatives in their own planning.

Current food safety rules were adopted after bipartisan approval of the Food Safety Modernization Act and a 5-year rule making process that FDA conducted with stakeholders, sometimes reversing directions to maintain consensus. Opponents of the Regulatory Accountability Act says the current food safety rules would not have survived “never-ending reviews and layers upon layers of wasteful Congressional and judicial red tape.”

However, there was Congressional involvement and judicial review, especially over deadline dates for the various rules.

Several consumer/environmental groups that are often involved in food safety issues have written several companies also often involved in food safety to persuade them to oppose the Regulatory Accountability Act when it comes to the Senate in May.

The “open letter” went out to Campbell Soup Company, Cargill, Coca-Cola, CVS Health, Domino’s Pizza, General Mills, PepsiCo, Target, Walmart, and Yum! Bands. “Food safety rules help reduce the risks posed by pathogens, additives, and pesticides,” says the letter. “But the “Filthy Food Act” passed by the House would create an unprecedented regulatory gauntlet through which no food safety rule or guidance could pass.”

Signing the letter were representatives of Food Policy Action, Food & Water Watch, Environmental Working Group, Consumers Union, Consumer Federation of America, and Center for Science in the Public Interest.

Putting aside whether the new law would truly be a “regulatory gauntlet” for regulations, some significant elements are included.  One would repeal the so-called “Chevron” doctrine, so named for a 1984 Supreme Court case of Chevron USA v. Natural Resources Defense Council Inc. that gave deference to agency legal interpretations when their decisions are challenged.

Also billion dollar rules would not take effect until timely filed litigation challenging their promulgation is resolved.  It also beefs up the existing prohibition on federal agency lobbying for their own rules.

The consumer/environmental groups claim the new Regulatory Accountability Act “would require officials at the U.S. Department of Agriculture, the Food and Drug Administration, and other agencies to seek out the least costly, and not the most beneficial, regulatory approach to food safety problems…”

“Manufacturers, retailers, and restaurants generally take food safety serious, which is why they should not stand by while their trade associations dismantle the food safety system,” said CSPI president Michael F. Jacobson. “Extremists like (White House chief strategist) Steve Bannon may sneer at what he calls the ‘administrative state,” but that’s generally what’s keeping E. coli, Salmonella, and Listeria out of our food supply.”

Jacobson is inviting the food companies “to work cooperatively with us to defeat this reckless and irresponsible piece of legislation.”



Food Safety ,

American Bakers Association Asks FDA to Reconsider Dietary Fiber Definition

February 25th, 2017
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The American Bakers Association (ABA) says that the current definition of dietary fiber is not practical or workable and requests that FDA reconsider its definition.

The association has encountered numerous unintended consequences and unaccounted costs and burdens associated with the definition and, therefore, requests that FDA rescind it. ABA also suggests FDA could address in the definition numerous concerns raised since it has been in use, including providing a comprehensive list of ingredients that can be declared as dietary fiber.

Alternatively, ABA requests the following:

•           Consider a less burdensome definition of dietary fiber.

•           Include additional examples of dietary fibers that meet FDA’s definition along with test methods that support

declaration of these fibers on the nutrition label.

•           Include additional details on FDA’s scientific review process, including information on:

(1) the process by which manufacturers may show that an ingredient has an identical chemical structure to an approved National Drug Code (NDC);
(2) FDA’s approach toward combination ingredients;
(3) additional examples of physiological endpoints and the agency’s suggested duration of studies for certain endpoints;
(4) what FDA considers to be appropriate statistical analysis of study results;

(5) the factors FDA will consider in evaluating scientific studies.

•           Alternatives FDA will use in conjunction with the rule making requirements to publicly announce its approval that an ingredient meets its definition of dietary fiber so that a manufacturer can include that ingredient in its dietary fiber declarations in advance of and apart from the formal rulemaking process.

•           Re-establish a compliance date based on a timeframe after FDA has worked out all the challenges associated with the new definition of dietary fiber, including approving pending citizen petitions. The current compliance date is less than 18 months away and FDA has indicated it will consider timing options to allow manufacturers to relabel or reformulate products once it has reviewed pending fiber petitions and comments submitted in response to the guidance and Science Review.

ABA will submit the comments it has received in response to FDA’s request for comments, to the Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non—digestible Carbohydrates Submitted as a Citizen Petition.

ABA says that bakers are significantly impacted by FDA’s changes to the nutrition label. Yeast-based bakery products are subject to fermentation and therefore face challenges with respect to the calculation of added sugars, even though added sugars from yeast—based products are not a high contributor to added sugars in the American diet. For products made from enriched flours, bakers must now, for the first time calculate and generate records reflecting the portion of folate that must be declared as folic acid, which has presented unforeseen challenges requiring consultation and clarification from the FDA.

In November 2016, the FDA published a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule.

Source: World Bakers


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Nutella for breakfast? Chocolate maker pushing FDA to reclassify spread

November 5th, 2016
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Nutella lovers enjoy the creamy spread on toast, pancakes, waffles and more– but is it really okay to eat all day?

Ferrero, the Italian company behind the chocolate hazelnut spread, are now making a case that their product is suitable as a breakfast food, not just something you should enjoy for dessert.

Ferrero wants the U.S. Food and Drug Administration to reduce Nutella’s serving size from two tablespoons to one, according to Bloomberg. The company already filed a petition with the FDA in 2014 asking for the food to be categorized along the lines of other a.m. spreads like jams and honey.

On Tuesday, the agency announced intent to seek more information on flavored nut-butter spreads, their planned use and usual consumption amounts. The amount of Nutella people really eat in one sitting is now under scrutiny.

Since 1993, the FDA has considered the spread to be among “other dessert toppings.” But Ferrero says the two-tablespoon serving size on the U.S. label could be confusing and lead people to think they should use that amount on their toast. The FDA sets “reference amounts customarily consumed” (RACC) for 139 categories of food products, which helps determine serving size.

The agency said it’s asking for information now because it recently issued a final rule updating certain RACCs (and, also, because of the petition).

“Because Nutella is used in the same manner as jams and jellies, uniformity in RACC values among Nutella, jams, and jellies would enable consumers to make informed nutritional comparisons of these similar products,” Ferrero wrote in its petition.

Almost three-quarters of Nutella consumed in the U.S. was used on bread in 2012, compared with just 2 percent on ice cream, Ferrero said. Starting on Nov. 2, the FDA began taking comments on the issue. The comment period will last for 60 days.



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FDA: to Redefine «Healthy» Claim for Food Labelling

October 8th, 2016
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The U.S. Food and Drug Administration (FDA) announced that it has started a public process to redefine the «healthy» nutrient content claim for food labelling. Redefining «healthy» is part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.

While FDA is considering how to redefine the term «healthy» as a nutrient content claim, food manufacturers can continue to use the term «healthy» on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

Public health recommendations for various nutrients have evolved, as reflected by the 2015 to 2020 Dietary Guidelines for Americans and the updated Nutrition Facts label. For example, healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet. Also, the nutrients of public health concern that consumers aren’t getting enough of have changed. FDA is publishing a «request for information» to solicit public input as it redefines the term «healthy». In addition, the Agency is planning other public forums to receive additional public input.

Source: bakenet:eu


Food Safety ,

Large Food Facilities Required to Meet This Deadline by Sept. 16

August 15th, 2016
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The Food Safety Preventive Controls Alliance (FSPCA) was specifically formed to help facilities comply with the new changing regulations.

The rule requires registered food facilities that manufacture, process, pack or hold food for human consumption to take these steps:

  • Maintain a food-safety plan;
  • Analyze where hazards pertaining to food safety exist in their operations; and
  • Put preventive controls into place for dealing with those hazards.

Facilities also have to verify and document that their preventive controls are working. Also, according to the rule, the plans must be re-analyzed at least once every three years.

Compliance dates vary according to the size of the company. But for the largest ones, the deadline is Sept. 16. Small and mid-sized companies have until September 2017, and very small companies have until September 2018.

 The reason behind the regulations

  • “The whole purpose is public health,” said Bob Brackett of the Food Safety Preventive Controls Alliance “If everyone’s onboard, we’ll have safer food.”
  • “FDA doesn’t make food safe,” said Jim Gorny, vice president of food Safety and technology for the Produce Marketing Association. “It’s the responsibility of the industry to make food safe. Ultimately, we’ll have an even safer food supply.”
  • “It’s about adopting a culture of food safety to produce safe food,” said Donna Garren, regulatory affairs and technical specialist with the American Frozen Food Institute.

 What if facilities miss the deadline?

  • If a facility is not in compliance, the FDA can issue a warning letter of violations and list the changes that need to be made. Once the changes are made, the FDA will re-inspect.
  • The agency can ask the facility to recall a product, or products, voluntarily.
  • The agency can mandate a recall.
  • The agency can withdraw a facility’s registration.
  • The agency can go to court and seek a permanent injunction.

Source: Abasto


Food Safety ,

FDA modernizes Nutrition Facts label for packaged foods

May 28th, 2016
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The US Food and Drug Administration took a major step in making sure consumers have updated nutritional information for most packaged foods sold in the United States, that will help people make informed decisions about the foods they eat and feed their families.

“I am thrilled that the FDA has finalized a new and improved Nutrition Facts label that will be on food products nationwide,” said First Lady Michelle Obama. “This is going to make a real difference in providing families across the country the information they need to make healthy choices.”

“For more than 20 years, Americans have relied on the Nutrition Facts label as a leading source of information regarding calories, fat and other nutrients to help them understand more about the foods they eat in a day,” said FDA Commissioner Robert Califf, M.D. “The updated label makes improvements to this valuable resource so consumers can make more informed food choices – one of the most important steps a person can take to reduce the risk of heart disease and obesity.”

The new Nutrition Facts label will include the following:

  • An updated design to highlight “calories” and “servings,” two important elements in making informed food choices.
  • Requirements for serving sizes that more closely reflect the amounts of food that people currently eat. What and how much people eat and drink has changed since the last serving size requirements were published in 1993. By law, the Nutrition Labeling and Education Act, requires that serving sizes be based on what people actually eat.
  • Declaration of grams and a percent daily value (%DV) for “added sugars” to help consumers know how much sugar has been added to the product. It is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugars, and this is consistent with the scientific evidence supporting the 2015-2020 Dietary Guidelines for Americans.
  • “Dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for certain multi-serving food products that could be consumed in one sitting or multiple sittings. Examples include a pint of ice cream and a 3-ounce bag of chips. With dual-column labels available, people will be able to easily understand how many calories and nutrients they are getting if they eat or drink the entire package/unit at one time.
  • For packages that are between one and two servings, such as a 20 ounce soda, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.
  • Updated daily values for nutrients like sodium, dietary fiber and vitamin D, consistent with Institute of Medicine recommendations and the 2015-2020 Dietary Guidelines for Americans. Daily values are reference amounts of nutrients to consume or not to exceed and are used to calculate the %DV that manufacturers include on the label.
  • Declaration of Vitamin D and potassium that will include the actual gram amount, in addition to the %DV. These are nutrients that some people are not getting enough of, which puts them at higher risk for chronic disease. The %DV for calcium and iron will continue to be required, along with the actual gram amount. Vitamins A and C will no longer be required because deficiencies of these vitamins are rare, but these nutrients can be included on a voluntary basis.
  • “Calories from Fat” will be removed because research shows the type of fat is more important than the amount. “Total Fat,” “Saturated Fat,” and “Trans Fat” will continue to be required.
  • An abbreviated footnote to better explain the %DV.

The FDA is also making minor changes to the Supplement Facts label found on dietary supplements to make it consistent with the Nutrition Facts label.
Most food manufacturers will be required to use the new label by July 26, 2018. Manufacturers with less than USD10m in annual food sales will have an additional year to comply with the new rules. The FDA plans to conduct outreach and education efforts on the new requirements.



Packaging ,

FDA Issues Final Food Defense Regulation Under Food Safety Modernization Act

May 28th, 2016
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The US Food and Drug Administration have finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

The FDA is committed to working with both industry and its state, local and tribal partners to ensure effective implementation of this new rule. Implementation of the Intentional Adulteration rule and all FSMA final rules will require partnership, education, and training. The FDA and others will provide industry with valuable tools to make compliance with the final rules easier, such as guidances, training courses and a technical assistance center.

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.

The FDA has now finalized all seven major rules that implement the core of FSMA. The Intentional Adulteration final rule builds on the Preventive Controls rules for human food and animal food, the Produce Safety rule, Foreign Supplier Verification Program rule, Accreditation of Third-Party Certification rule and the rule on Sanitary Transportation of Human and Animal Food. These seven rules will work together to systemically strengthen the food safety system and better protect public health.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

In a statement from The Grocery Manufacturers Association, (GMA) Pamela G. Bailey, president and CEO said: “We welcome the release by FDA of its final rule on prevention of intentional product adulteration, the last of the seven major foundational rules for FSMA. FSMA ensures that prevention is the cornerstone of our nation’s food safety strategy. It places new responsibilities on food and beverage manufacturers and provides the FDA with the resources and authorities it needs to further strengthen our nation’s food safety net.”

“GMA will continue its work to support the effective implementation of FSMA and will maintain a leadership role on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, both in the US and the entire global supply chain,” she said.



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U.S. FDA no questions regarding Renaissance BioScience Corp.’s Non-GMO Acrylamide-Reducing Yeast

May 28th, 2016
Comments Off on U.S. FDA no questions regarding Renaissance BioScience Corp.’s Non-GMO Acrylamide-Reducing Yeast

Renaissance BioScience Corp. announces U.S. FDA acceptance of GRAS notification for Non-GMO Acrylamide-Reducing Yeast

Renaissance BioScience Corp., a leading global yeast innovation company, is pleased to announce that the U.S. Food and Drug Administration has “no questions” in regards to Renaissance’s Generally Regarded as Safe (GRAS) notice (GRAS Notice No. GRN 000604) for its non-GMO, acrylamide-reducing (AR) baker’s yeast strain.

“The acceptance of our acrylamide-reducing yeast as GRAS by the U.S. FDA is a significant step forward in the commercialization and marketing of the AR yeast for a wide variety of food and beverage sectors,” said Dr. John Husnik, CEO of Renaissance BioScience. “GRAS status provides further validation to food manufacturers worldwide to apply our innovative AR yeast to address the acrylamide problem that continues to be a concern in many foods and beverages. In foods that already contain yeast we believe our AR yeast can quickly and seamlessly replace the use of conventional baker’s yeast, with minimal or no change to the food production process, thereby reducing the amount of acrylamide in the final consumer product by up to 90%. For foods that do not traditionally contain yeast it is also possible to significantly reduce acrylamide levels using our AR yeast by making reasonable process alterations, as our laboratory results have shown.”

“With government reports concerning acrylamide being issued recently by the U.S. FDA, the EFSA, the U.K. FSA, Health Canada and the Japanese government, acrylamide reduction continues to be an important focus for health and food safety regulators, governments, and food and beverage manufacturers around the world ,” added Dr. Husnik.

Renaissance’s AR yeast now joins other mainstream ingredients, such as conventional baker’s yeast and other food and beverage yeasts, that have GRAS status. The company’s wholly owned subsidiary, Renaissance Ingredients Inc., is responsible for commercializing the AR yeast to the global food and beverage industry.

“Recognizing that food safety regulators have requested lowering acrylamide levels to As Low As Reasonably Achievable (ALARA), Renaissance Ingredients Inc. is pleased to have completed another step in the process to make our AR yeast commercially available as a safe and effective new tool for food manufacturers to lower acrylamide levels,” commented Renaissance Ingredients Inc.’s President Dr. Matthew Dahabieh.  Renaissance Ingredients Inc. is currently in discussions with potential production partners to allow for large-scale commercial availability of AR yeast for food manufacturers.

Source: Asia Food Journal


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