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fda, nutrition, facts, label, food labelingOn May 20, 2016, the U.S. Food and Drug Administration (FDA) finalized two new rules that mandate significant changes to Nutrition Facts Labels for food and beverages.  FDA’s goals of updating the Nutrition Facts Label include:

  • Making it easier for consumers to make better informed food choices by emphasizing certain nutrition aspects, such as calories and serving sizes.
  • Updating serving sizes to more realistically reflect U.S. food consumption.
  • Reflecting updated scientific information, including the link between diet, chronic diseases, and public health.

Calories

The new Nutrition Facts Label format considerably increases the font size of the word “Calories” and the number of calories.  The number of calories is also bolded. The number of calories from fat is removed from the label.  According to FDA, “research shows the type of fat is more important than the amount.”

Serving Sizes

fda nutrition facts chart, dual columnThe font size of the words “servings per container” and the serving size declaration also feature an increase.  The serving size declaration is bolded.

Along with emphasizing the serving size on the new Nutrition Facts Label, FDA’s rules create new requirements for determining the serving size of a product.  By law, serving sizes must reflect the amount of food and beverages people truly consume rather than what they should consume.  For example, before the rule, many 20 ounce bottles of soda were labeled as 2 servings despite the fact that the average U.S. consumer drinks an entire 20 ounce bottle at once.  Now, 20 ounce sodas are required to be labeled as one serving.  The same is true for other packages that were previously labeled as two servings but typically consumed in one sitting.  FDA’s new rules update various other serving sizes as well.  For example, the serving size of ice cream increased from ½ cup to 2/3 cup.

FDA’s new rules require certain products that may be consumed in either one or multiple sittings to bear a “dual column” label that identifies calorie information for both “per serving” and “per package/per unit”.

Added Sugars

The new Nutrition Facts Label format differentiates “Added Sugars” from “Total Sugars”.   According to FDA, “scientific data shows that 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 sugar.”

Nutrient Daily Values

FDA’s new rules add vitamin D and potassium to the required list of nutrients, while the inclusion of vitamins A and C were made optional. The rules update daily values for sodium, dietary fiber, and vitamin D based on new scientific evidence. The new Nutrition Facts Label lists the actual amount of vitamin D, calcium, iron, and potassium in addition to the percent Daily Value.

The new rules also update the percent Daily Value footnote to read “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”

FDA’s rules mandate minor changes to Supplements Facts Labels for dietary supplements as well to ensure consistency with Nutrition Facts Labels for food and beverages.

Compliance Dates

Most food manufacturers are required to use the new label by July 26, 2018. Manufacturers with less than $10 million in annual food sales have an additional year to comply.

It’s prudent for food facilities to begin redesigning their labeling now, as the process of designing, printing, and relabeling can take some time. Relabeling early will allow for a smooth and efficient transition from old to new labeling within the time allotted by FDA.

Registrar Corp’s Labeling and Ingredient Review Specialists can help food facilities update their labels to comply with FDA’s new rules.  Along with updating a facility’s Nutrition Facts Label, Registrar Corp will review all aspects of a food’s labeling, including ensuring any claims made are within FDA’s boundaries to do so. For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

Due to evolving nutrition research and a citizen petition filed by KIND LLC, the U.S. Food and Drug Administration (FDA) has decided it’s a good time to reevaluate its definition of the term “healthy”. The agency plans to gather public comment on use of the term “healthy,” along with other nutrient content claims, in the near future.

The decision was announced as part of a statement FDA published last week regarding KIND LLC’s use of the term “healthy” on its food labeling.  FDA issued a warning letter to KIND in March 2015 due to KIND’s use of the term “healthy” on products that did not meet FDA’s criteria for labeling products as such.  After evaluation of KIND’s corresponding corrective actions, FDA issued a closeout letter to KIND in April 2016.  After KIND received its closeout letter, the company asked FDA if it could use the phrase “healthy and tasty” to present its corporate philosophy so long as the phrase:

  • Isn’t represented as a nutrient content claim, and
  • Is not placed on the same display panel as nutrient content claims or nutrition information.

FDA agreed to allow KIND to use the phrase under these circumstances.

FDA’s Current Definition of Healthy

Industry has taken issue with FDA’s current regulation of “healthy” because it rules out foods widely recognized as healthy and nutritious, such as almonds, salmon and avocados, due to high fat content.

FDA currently allows “healthy” and similar terms to be used as implied claims on food labeling if the food meets the following conditions:

FDA Healthy Labeling

Source

Read more on KIND’s Citizen Petition for examples of suggestions the company gave to FDA for updating its regulations.

Reevaluating Use of the Term “Natural”

In a similar instance, FDA recently decided to reevaluate the use of the term “natural” on food labeling.  There is currently no formal definition for the term natural, but FDA has received four citizen petitions on the matter since its decision not to regulate the term in 1991. FDA began accepting comments on use of the term “natural” in November 2015. The comment period closed on May 10, 2016.  The New York Times reports that FDA is currently in the process of reviewing those comments, a process which could take months.

FDA’s food labeling regulations are strict and extensive, and understanding the requirements to make certain claims can be complicated.  Registrar Corp’s Labeling and Ingredient Review Specialists can review food and beverage labeling for FDA compliance, including ensuring the product meets FDA requirements to make any claims listed.  For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 28973) that extends the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco.  The final rule becomes effective on August 8, 2016 (90 days from the date of publication).

FDA considers tobacco use to be a significant threat to public health.  According to FDA, smoking is the leading cause of preventable disease and death in the United States. Under the final rule, newly-regulated tobacco products are subject to premarket review and authorization by FDA.  Manufacturers of these newly-regulated tobacco products must register their establishments and list their products with FDA as well as place health warnings on product packages and advertisements.  Manufacturers will not be able to market their tobacco products as modified risk (i.e., “light”, “low”, or “mild”) without FDA authorization.  Manufacturers must also report ingredients and harmful and potentially harmful constituents to FDA.

Registration and Listing Requirements: Differences for Domestic and Foreign Manufacturers

The new registration and listing requirements will initially only apply to domestic tobacco manufacturers. Section 905 of the Food, Drug, and Cosmetic Act requires FDA to issue a rule through the notice and comment rulemaking process in order to apply the registration and product listing requirements to foreign manufacturers.  FDA has announced its intent to issue a rule requiring registration and listing for foreign tobacco manufacturers in the Unified Agenda and expects to publish the proposed rule in September 2016.

Registrar Corp can assist tobacco manufacturers in registering and listing their products with FDA per the new requirements.

The Rule’s Effect on Youth Access to Tobacco Products

While the use of traditional cigarettes by minors has decreased, their use of other tobacco products has increased significantly.  According to FDA, e-cigarette use among high school students rose from 1.5 percent in 2011 to 16 percent in 2015 (a 900 percent increase). A goal of FDA’s final rule is to protect youth from the dangers of tobacco via age-restrictions and restricting advertising that appeals to minors.

Before FDA finalized the rule, there were no federal regulations prohibiting the sale of e-cigarettes, hookah tobacco, or cigars to consumers under the age of 18.  Under the new rule, these products can no longer be sold to minors, either in person or online.  Sellers must verify the age of purchasers by photo identification.  The rule also prohibits the distribution of free samples or selling covered tobacco products in vending machines (unless in an adult-only facility).

Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations.  Registrar Corp can help tobacco product manufacturers determine how FDA’s new rule applies to their particular products.  Registrar Corp can register manufacturers and list tobacco products with FDA as well as review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations.

For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

On May 4, 2016, the U.S. Food and Drug Administration (FDA) announced that it had signed a Food Safety Systems Recognition Arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada).  This means that after thorough evaluation, FDA has determined that Canada’s food safety systems provide public health protection comparable to those of the United States. The arrangement is part of the US-Canada Regulatory Cooperation Council, which aims to leverage resources and reduce unnecessary duplication within the countries’ food safety systems.

FDA, CFIA, and Health Canada began assessing each others’ food safety systems in 2015. Canada is the second country that FDA has recognized as having comparable food safety systems.  New Zealand was the first, recognized in 2012.  FDA is currently evaluating Australia and the European Commission.

According to the arrangement, FDA and Canada will exchange regulatory and scientific information related to food safety at least once per year.  The countries will discuss Systems Recognition reassessments, reviews, or audits at least once every five years.  Certain food and beverage products are excluded from the US-Canada arrangement, including meat, poultry, processed egg products, farmed catfish and catfish products, grade “A” milk and grade “A” milk products, raw bivalve molluscan shellfish, dietary supplements, and natural health products.

Food Safety Systems Recognition and the Food Safety Modernization Act

FDA’s Food Safety Modernization Act (FSMA) creates new food safety requirements for both food facilities and U.S. importers.  Food facilities exporting food from countries with recognized food safety systems and importers with suppliers in countries with recognized food safety systems are still subject to FSMA requirements, but have some modifications and exemptions.

Requirements for FDA-Registered Food Facilities

FDA’s Preventive Controls Rules require that all food facilities that manufacture, process, pack, or hold food for consumption in the U.S. have written food safety plans, including a hazard analysis, preventive controls, a supply chain program, and other components.  As part of their supply chain program, covered facilities must conduct verification activities to ensure their suppliers’ compliance with FDA regulations.

The rule identifies onsite audits as an appropriate verification activity for suppliers of raw materials and other ingredients. Instead of conducting an onsite audit, food facilities with suppliers in countries with recognized food safety systems can rely on an inspection by the food safety authority of that country, so long as the inspection occurs within one year of the date that the onsite audit is required to be conducted.

Requirements for U.S. Importers

FDA’s Foreign Supplier Verification Program (FSVP) rule creates many new requirements for U.S. importers, including monitoring, approving, and creating an FSVP for each foreign supplier.  However, importers can import from suppliers in countries with recognized food safety systems without conducting a hazard analysis, approving and verifying those suppliers, or conducting FSVP activities for those suppliers.  In order to take advantage of these modified requirements, the importer must continuously monitor eligible suppliers to ensure they are in good compliance standing with their country.

Registrar Corp helps food facilities comply with new requirements under FDA’s Food Safety Modernization Act.  Registrar Corp’s Food Safety Specialists can develop or review Food Safety Plans as well as help facilities prepare for an onsite audit. Registrar Corp’s FDA Compliance Monitor allows users to effortlessly monitor their suppliers for FDA compliance issues.

For assistance determining your particular requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

On April 18, 2016, the U.S. Food and Drug Administration (FDA) issued a new Import Alert for “Aquacultured Shrimp and Prawns from Peninsular Malaysia Due to Presence of Drug Residues from Unapproved Animal Drugs or the Presence of Unsafe Food Additives (Import Alert 16-136).”  FDA testing revealed that approximately one-third of shrimp and prawn imports from peninsular Malaysia contained residues of nitrofurans and/or chloramphenicol.  This is an alarming amount, considering that Malaysia was one of the top 10 suppliers of shrimp and prawns to the United States in 2014.

FDA considers prolonged exposure to Nitrofurans and chloramphenicol as a risk to human health. Both drugs are carcinogens, and use of the drugs in animals may contribute to antimicrobial resistance.  Shrimp or prawns containing nitrofurans and/or chloramphenicol are considered adulterated.

The Import Alert means that all shipments of shrimp and prawns from peninsular Malaysia (with the exception of Sabah and Sarawak) are subject to Detention Without Physical Examination (DWPE) upon arrival to the United States.  According to FDA, “the owner or consignee of the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not bear or contain any nitrofuran or chloramphenicol residues” in order to secure release of a shipment detained under this Alert.

There are multiple pre-existing alerts similar to Import Alert 16-136, such as Import Alert 16-129 for “Detention Without Physical Examination of Seafood Products Due to Nitrofurans.”  Records indicate that this Import Alert has been around since at least 2009.  So why would FDA create a new Import Alert for virtually the same issue?

Essentially, the existing Import Alerts require that a facility be specifically found to be shipping adulterated products in order to be added to the “Red List” of those alerts. With this new alert, however, the prevalence of violation from peninsular Malaysia provides FDA with evidence to believe that all manufacturers from that region appear violative. As a result, all Malaysian companies exporting shrimp and prawns to the United States will find their shipments stopped by FDA, and they will need to submit evidence of compliance for each shipment in order for the products to be released into the US.

Food facilities in Malaysia that export shrimp or prawns to the United States can petition FDA for exemption (also known as being put on the “Green List“) from Import Alert 16-136.  The petition process is lengthy, as it requires documentation of corrective actions or preventive measures, proof of approximately five to twelve compliant shipments, and a written petition.  Registrar Corp’s Import Alerts Department can guide facilities through the Import Alert petition process, including organizing the petition and submitting it to FDA.

For assistance with FDA Import Alerts, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-Hours a day at www.registrarcorp.com/livehelp.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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