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FDA Import Refusals: Top 5 Labeling Violations

October 22, 2014 by David Lennarz

Labeling violations are one of the leading causes of food import refusals to the United States by the U.S. Food and Drug Administration (FDA).  According to OASIS, FDA’s import refusal database, FDA has identified approximately 5,029 labeling violations on products being offered for import so far in 2014 alone.  Registrar Corp has compiled a list of the five most commonly committed labeling violations.

1. “The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.”

Over a thousand import refusals in 2014 have been fully or partially due to missing nutritional information.  FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel.  The nutrition facts panel displays information such as a serving size, the number of calories the product contains, and the percentage of your suggested daily fat intake it contains. FDA takes nutrition labeling very seriously.  There is even an import alert regarding nutritional labeling violations.  If a product is found to be in violation of certain nutritional labeling requirements, it is noted in FDA’s PREDICT system.  If the same product is found to be in violation again 60 or more days after the initial violation, that product will be added to the import alert and be subject to detention without physical examination (DWPE)

2. “It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.”

FDA requires that every ingredient contained within a food or beverage be disclosed on the label in descending order of the prominence of the ingredient.  However, FDA does not require you to reveal the exact formulation as that may be considered a trade secret.

3. “Required label or labeling appears to not be in English per 21 CFR 101.15(c)”

FDA requires that all words, statements, and other information on labels appear in English.  A label may include other languages along with English, but if a foreign language is used anywhere on the label, all of the information on the label must appear in that language as well.

4. “The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.”

FDA requires that a net quantity statement (a statement that provides the amount of food in a container or package) appears on the bottom 30% of the principal display panel (PDP) of a food label. The net quantity statement should only take into account the food, not the weight of the container, the packaging materials, etc.  The minimum type size for the net quantity statement depends on the size of the PDP.

5. “The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.”

FDA requires that the name and address of the manufacturer, packer, or distributor be listed on a food label.  Unless the listed name is the manufacturer, the label must also state the firm’s relationship to the product (“manufactured for”, “distributed by”, etc.). The address must include the city, state, zip code, and if the firm’s address is not listed in the current city directory or phone book, the street address.  The name and address are generally required to be placed together on the label.

If FDA discovers that your product has one of these five violations or any of the other 70 FDA labeling violations, FDA will consider the product to be “misbranded” and may refuse your product entry into the United States.  It is a prohibited act to distribute a misbranded product in the U.S. under the Food, Drug, and Cosmetic Act, and FDA can bring a civil or criminal action against a person who commits a prohibited act.

Along with checking at ports of entry, FDA will examine product labels during routine facility inspections.  The Food Safety Modernization Act (FSMA) mandated that FDA increase the number of foreign inspections it conducts each year.  By 2016, all facilities distributing products in the U.S. can expect to be inspected every 3 to 5 years, with high risk facilities being inspected most frequently.   If FDA finds a non-compliant label during an inspection, not only will the agency deem the product misbranded, but they also may decide to reinspect your facility at a later date to ensure the labels have been brought into compliance. If so, FDA will charge $217 USD per hour for reinspections of domestic facilities and $305 USD per hour for reinspections of foreign facilities.

Registrar Corp can help assure that your product labels are FDA compliant through our label review service.  Our Regulatory Specialists will cross reference your food labeling against thousands of pages in the Code of Federal Regulations and will return to you a modified, print-ready label, along with a detailed report explaining the recommended changes.  Additional reviews of the same label within 90 days of the initial report are offered free of charge.

For more information about FDA food and beverage label regulations, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from a Regulatory Advisor:


FDA to Launch New Office of Pharmaceutical Quality

October 20, 2014 by David Lennarz

The U.S. Food and Drug Administration (FDA) plans to launch a new office in 2015.  This new Office of Pharmaceutical Quality (OPQ) will be dedicated to ensuring that quality medicines are available to U.S. citizens.  According to the OPQ webpage, OPQ will create a uniform drug quality program across all domestic and foreign sites of manufacture and across all drug product areas.

OPQ was proposed in September 2012 by Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), who will serve as the acting director of OPQ.  In a statement to CDER staff, Woodcock said the new office would help “provide better alignment among all drug quality functions at CDER, including review, inspection, and research.”

Woodcock will be joined in leadership by Deputy Director Lawrence Yu, and many others from currently existing FDA offices:

  • Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
  • Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
  • Office of Biotechnology Products (OBP): Director: Steve Kozlowski
  • Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
  • Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
  • Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
  • Office of Process and Facilities (OPF): Christine Moore (Acting)
  • Office of Surveillance (OS): Theresa Mullin (Acting)

Registrar Corp, an FDA compliance firm, stays up to date on FDA news and will keep readers posted as the new OPQ office unfolds.  Should you need any assistance with registering, listing, or labeling drug products, Registrar Corp can help.  Contact us at 1-757-224-0177 or receive Live Help from our regulatory specialists:


Registrar Corp Exhibiting at SIAL Paris 2014

October 17, 2014 by David Lennarz

Next week, Registrar Corp is heading to Paris, France for SIAL, the world’s largest food innovation marketplace.  Taking place from October 19 to 23, SIAL 2014 will host 6,300 exhibitors from 105 countries around the world.  Along with visiting exhibits, SIAL attendees can head to the SIAL Innovation Observatory to discover award-winning products and learn about the latest trends in the food market.

Need to know if your innovative new products meet U.S. Food and Drug Administration (FDA) regulations?  Still need to renew your FDA registration for FY 2015? Registrar Corp can help.  Stop by Registrar Corp’s SIAL exhibit stand 087 (Hall 4, U.S. Pavilion) for answers to all your FDA-regulation related questions.  You can also schedule a time to meet with us at the show.


Registrar Corp to Present FSMA Seminar in Portugal

October 14, 2014 by David Lennarz

Registrar Corp, along with the American Chamber of Commerce, will be hosting a seminar in Lisboa, Portugal on October 17, 2014.  The seminar will take place from 9:30AM to 1PM in the CECOA auditorium.  We will be presenting on U.S. Food and Drug Administration (FDA) requirements for exporting food to the United States, as well as the new Food Safety Modernization Act (FSMA), the largest reform of U.S. food safety regulations in over 70 years.

FDA requires that food and beverage companies selling food in the U.S. register with FDA and, under FSMA, FDA now requires that these registrations be biennially renewed.  FDA also requires food and beverage companies to follow strict labeling requirements and manufacturing practices, and under FSMA, FDA is now permitted to charge hourly fees for reinspections.  We will cover all this and more at the seminar and answer any remaining questions at the end.  You must register to attend this seminar.

If you are unable to attend the show, but would still like to learn about FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist any time at


Registrar Corp to Attend SupplySide West 2014

October 8, 2014 by David Lennarz

Registrar Corp will be in Las Vegas on October 8th and 9th, 2014 to attend SupplySide West, the world’s largest expo for ingredient suppliers and finished product manufacturers.  SupplySide West 2014 boasts its largest show floor yet, with over 1,700 exhibitors.

SupplySide West offers exhibitions and presentations for the dietary supplement, food, beverage, animal nutrition, cosmetic, and pharmaceutical industries, all of which are regulated by the U.S. Food and Drug Administration (FDA).  Registrar Corp will be at the show to answer any questions industry professionals may have regarding FDA regulatory requirements.

For information about FDA regulations of food, drugs, or cosmetics, or to schedule a time to meet up with a Registrar Corp representative at the show, contact Registrar Corp by phone at +1-757-224-0177 or through the online Live Help service:

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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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