Registrar

Assistance with U.S. FDA Regulations

Drugs

FDA Specifies DUNS Number as Unique Identifier for Drug Establishments

In November 2014, the U.S. Food and Drug Administration published “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012, directed the Secretary of Health and Human Services (who then delegated FDA) to specify a UFI system for registration of domestic and foreign drug establishments.

In the guidance, FDA specified the Data Universal Numbering System (DUNS) as its preferred UFI system for drug establishments. According to the guidance, “FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing” and feels that DUNS numbers will act as sufficient UFIs. Section 510 of the Food, Drug, and Cosmetic (FD&C) Act mandated that, once the UFI was specified, drug establishments would be required to include a UFI in their initial and annual registrations.  Since FDA has already been requiring drug establishment registrations to include DUNS numbers since 2009, registrations will remain unchanged. DUNS numbers are assigned free of charge to all drug establishments.

Registrar Corp can help drug establishments obtain a DUNS number, as well as submit their electronic registrations for them. If you have any questions about DUNS requirements or any other FDA regulations for drug establishments, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Specialist 24 hours a day at https://regstaging.wpengine.com/livehelp.

FDA Opens Inspection Data to Public in New Dashboard

On October 2, FDA announced on its blog a new data dashboard where users can view data regarding FDA inspections and enforcement.  The dashboard currently contains data for fiscal year (FY) 2009 to FY 2013, and FDA plans to update the database twice a year.  For now, the datasets only include final actions.  Some of the data was previously available on the FDA website in downloadable spreadsheets, but in the dashboard, the information is presented as graphs.

When you enter the dashboard, you have two options for how to view the data:

Reports and Trends

The reports and trends section of the dashboard references more general statistics, such as the breakdown of FDA inspection conclusion reports.  When FDA concludes an inspection it reports one of three things: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).  OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.  VAI means FDA found objectionable conditions, but they did not warrant regulatory significance.  NAI means FDA found no objectionable conditions that warrant further action.

In the dashboard, users can see how many of each type of inspection conclusions were reported by each FDA center.  For example, in FY 2013, the Center for Food Safety and Applied Nutrition (CFSAN) reported significantly more NAI conclusions than OAI or VAI conclusions.  The Center of Drug Evaluation and Research (CDER), however, reported nearly the same number of VAI conclusions as NAI conclusions.

Inspections by Country

You can also view data in the dashboard more specifically by country.  You can see the number of inspections conducted in each country, and by clicking on a country, you can access more detailed information.  You can see the number and types of inspection conclusions reported in each country and the number of inspections conducted by each FDA center in each country.

According to the dashboard, the United States has undergone the most FDA inspections in the past 5 years, with its count at an outstanding 81,971.  Canada comes in second with 782 inspections, and China is a close third with 780.  Keep in mind that there are significantly more U.S. facilities registered with FDA than other countries.  Speaking of food facilities alone, over 80,000 U.S. food facilities are registered with FDA, while there are 6,433 Canadian food facilities registered with FDA.

It’s important to know that in 2011, the Food Safety Modernization Act (FSMA) directed FDA to increase the number of food facility inspections it conducts.  FSMA mandated that FDA inspect all high risk U.S. facilities by 2016 and again every three years thereafter.  FDA must inspect all non-high-risk U.S. facilities by 2018 and again every five years thereafter.   For foreign facilities, FDA must double the number of inspections it conducts every year through 2016.

Along with mandating that FDA increase the number of inspections, FSMA granted FDA the authority to collect reinspection fees.  Initial inspections cost nothing, but if the inspection reveals certain food safety issues and FDA decides to return, FDA will charge for every hour spent on the reinspection.  This includes the time it takes FDA to prepare for the reinspection and to travel to and from the facility. The cost for reinspections in FY 2015 is $217 per hour for domestic facilities and $305 per hour for foreign facilities.

With the new financial risks associated with FDA inspections, it’s a good idea to prepare in advance.  Registrar Corp offers a mock FDA inspection service for food facilities.  We will send a food safety expert trained in FDA inspections to a facility to help prepare.  If FDA sets a date for an inspection, this mock inspection service is offered free of charge to Registrar Corp’s U.S. Agent clients, other than travel and lodging expenses.

Registrar Corp is a consulting firm that helps companies comply with FDA regulations.   Along with mock inspections, we offer registration services and label reviews to food, drug, device, and cosmetic companies.  If you are interested in our services or have any questions regarding FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist 24 hours a day at https://regstaging.wpengine.com/livehelp.

*Note: Similarly in August, FDA revealed a new API that gives users access to drug labeling and enforcement statistics.

Did you know: FDA Considers Online Promotion as Labeling?

On June 27, 2014, the U.S. Food and Drug Administration (FDA) issued a warning letter to Zarbee’s Inc. regarding claims the company made on its website and social media.  According to FDA, the health claims made about some of the products that Zarbee’s sells online “cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.” FDA warned that, because Zarbee’s had not completed the proper requirements for distributing drugs in the U.S., the products could not be legally introduced into U.S. commerce.

FDA also wrote that Zarbee’s website offered products as a treatment for conditions that are not self-diagnosable or self-treatable, making it impossible to include adequate directions for safe and effective use for those intended uses. Because of this, FDA deemed those products to be misbranded.

Many companies don’t consider their online presence when working to comply with FDA regulations. What many don’t know is that FDA considers websites and social media to be an extension of product labeling, meaning that claims and information that a company puts online regarding its FDA-regulated product are subject to FDA review and requirements. This is true for all domains because consumers in the U.S. can still access out-of-country domains. For example, a Canadian company cannot refrain from making an FDA-restricted claim on its “.com” domain while still making the claim on its “.ca” domain, even if that claim is allowed in Canada.

In some cases, FDA may even consider third-party promotion to be part of a company’s labeling if FDA believes the company had any influence over the promotion. For example, in the warning letter to Zarbee’s, FDA criticized the company for “liking” certain testimonials about its products’ health benefits on Facebook.  It appears that, though the testimonials were written by consumers, Zarbee’s “likes” were considered to be endorsements of the consumer statements.

Registrar Corp offers a label review service for drug, food and beverage, medical device, and cosmetic companies. Our Regulatory Specialists will assess all aspects of your labeling, including your website, and suggest modifications where necessary.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. If you have questions about FDA labeling regulations or any other FDA regulations, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://regstaging.wpengine.com/livehelp.

Registrar Corp Featured in Choose Hampton

The City of Hampton, Virginia featured Registrar Corp as part of their Choose Hampton campaign. Take a couple minutes to check out the video and hear Registrar Corp Vice President and Co-Founder David Lennarz talk about the founding of the company.

Are you looking for a career in Hampton, Virginia? Registrar Corp has career opportunities that let you utilize your skills in food science, scientific research, technical writing, foreign language, and more, while assisting companies to import products into the United States in compliance with FDA regulations. View currently available positions here.

Non-Compliance with FDA Labeling Requirements Leads to Numerous Recalls

Recalls require products to be removed from the market until the issue in question is resolved. Companies can initiate a recall themselves, but the U.S. Food and Drug Administration (FDA) can also request or order a recall. This situation can be a financial burden for a company. Products being off the market can lead to a loss of potential sales, and it takes time and money to fix the necessary problems.

In recall cases involving food the losses can be even greater. The FDA Food Safety Modernization Act (FSMA) authorizes FDA to order mandatory recalls of articles of food if the responsible party fails to voluntarily conduct a recall. FSMA also authorizes FDA to collect fees for non-compliance with food and feed recall orders. Non-compliance with a recall order includes not initiating an FDA ordered recall, not conducting the recall in the manner specified by FDA, and not providing FDA with requested information regarding the recall.

In July 2014 alone there were 143 recalls due to labeling issues, 94 of which were food products. The labeling issues included improper claims, such as claiming to be organic, and missing or incorrect required information like instructions, ingredients, and expiration dates. FDA label requirements can be complicated. Registrar Corp can revise your food, drug, medical device or cosmetic label to comply with U.S. FDA regulations.

Registrar Corp is an FDA consulting firm that helps companies with U.S. FDA regulations. If you have questions about FDA label requirements or any other FDA regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://regstaging.wpengine.com/livehelp.

Does FDA Classify Your Cosmetic as a Drug?

On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. The final rule requires specific labeling statements based on the results of these tests. As of December 17, 2013, all OTC sunscreens products were expected to comply with the revised OTC drug regulations.

Many countries define drugs and cosmetics differently from the United States. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, however, sunscreens are regulated as drugs. Cosmetics and drugs are subject to different regulatory requirements in the United States. Please note that some “personal care products” are drugs, or both cosmetics and drugs, under U.S. law.

The use of the term “sunscreen” or claims regarding sun protection on a product’s labeling may cause to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses such as a color additive or to protect the color of the product. I n order to avoid consumer misunderstanding, a cosmetic product that contains a sunscreen ingredient and uses the term “sunscreen” or similar sun protection claims on its labeling must qualify the term by describing the cosmetic benefit of the sunscreen ingredient. Accordingly, only those products that contain a sunscreen ingredient solely for a nontherapeutic, nonphysiological use, and which include a labeling statement that accurately describes that use, may be marketed as cosmetic products.

Improper labeling of your product can have severe repercussions as the labeling and composition requirements for cosmetics and drugs are very different. A mislabeled product may be deemed “misbranded” and denied entry into the United States.

If you are concerned about the classification of your product, the regulatory status of your ingredients, or the labeling and that accompany your product, Registrar Corp can assist. Registrar Corp’s Label & Ingredient Review service will research how all these regulations will impact your product and assist you in ensuring compliance as you export to the United States. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at https://regstaging.wpengine.com/livehelp or call us at +1-757-224-0177.