Registrar

Assistance with U.S. FDA Regulations

Cosmetics

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.

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.

Registrar Corp Receives Perfect Score on GlassDoor.com

FDA regulatory consultancy firm, Registrar Corp, received a 5 out of 5 stars rating as a desired workplace. Registrar Corp was the only firm in the Hampton Roads area of Virginia to receive a perfect score. The company was founded in 2003 to assist businesses comply with U.S. Food and Drug Administration (U.S. FDA) regulations. Since opening its headquarters in Hampton, Registrar Corp has expanded to nineteen international offices and has assisted more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts. The company currently employs 75 people in its Hampton office.

“Empowering employees to make decisions and be responsible for their projects, in consultation with their colleagues, has worked in our favor over the years,” says company Vice President, David Lennarz. “Even though employees multi-task through large volumes of work and critical deadlines, management strives to maintain a low-stress workplace. The rewards of hard work are happy clients and, in turn, happy clients motivate our employees.” This environment apparently contributes to Registrar Corp’s high employee retention rate. David Lennarz believes that retaining experienced people is one of Registrar Corp’s keys to success. “We are in a niche market so we cannot hire people off the street with the exact experience we need. Registrar Corp, therefore, invests in our employees with the understanding that they may not significantly contribute for months or even years. For this reason, it is in our benefit to hire people who want to learn and then retain them for as long as possible.”

GlassDoor is a jobs and careers site that offers an inside look at jobs and companies. GlassDoor reviews are anonymously created by former employees and incorporate salary data, company reviews and interview questions. Qualified candidates interested in submitting resumes to Registrar Corp can do so electronically or contact Registrar Corp by phone: 1-757-224-0177.

Shipment detained by FDA? Tips on how to best deal with a detention

An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released by FDA and allowed entry to the United States. The process delays shipments, complicates logistics and often adds storage costs. In addition, the Food Safety Modernization Act (FSMA), passed in 2011, authorizes FDA to charge importers and exporters for FDA’s costs in connection with some detentions.

Import “detentions” end in one of two ways. Either the product is released and allowed entry to the United States, or it is refused entry. An import “refusal” occurs when FDA determines that the product will not be allowed entry to the United States. At that point, the product must be shipped elsewhere or destroyed.

Obviously, importers and exporters should endeavor to avoid detentions, if possible. However, many detentions are unavoidable. If an imported product is detained, importers and exporters should take appropriate action so that FDA does not refuse entry.

For companies faced with a detention, it is critical to act properly. We recommend the following immediate actions:

1) First, gather the facts about the detention. Do not argue with FDA or the inspector who detained your product. Do not respond to the detention charges until you have gathered all of the facts about the detention and are aware of the FDA’s concerns. Be aware that it may be impossible for you to objectively view the situation from the position of the FDA inspector who detained your product and that you may not know all the nuances of a particular FDA regulatory requirement. Failure to appreciate the nuances of FDA detentions could cause you to inadvertently make matters worse. If the shipment has more than nominal value, it is worthwhile to retain a professional consultant familiar with the FDA and its procedures (like Registrar Corp) to assist with your detention, rather than attempt to resolve the issue without such assistance. Note to non-U.S. exporters: If you have retained Registrar Corp as your facility’s U.S. Agent for FDA communications, assistance with detentions may be provided at no additional cost (depending on the reason for the detention); simply contact your Registrar Corp Regulatory Adviser as soon as you learn the shipment is detained. Please contact Registrar Corp before you speak with FDA about the detention.

2) Upon detaining a shipment, FDA will issue a written document called the “Notice of Action” to the importer of record and to the customs broker who filed the entry. The Notice of Action will present the formal reasons why the products have been detained and will identify which section of the law FDA charges may have been violated. These are the detention charges to which you must respond — with documentary proof, not bombast. As shown by the statistics released by FDA (see December 8th blog), FDA may release detained products upon receipt of sufficient proof rebutting the charge stated by the Notice of Action. The Notice of Action will set a deadline for your response, called the “Respond By” date. That deadline should be taken seriously. If it passes without extension, it will be too late to avoid refusal even for admissible goods!

3) Contact Registrar Corp for immediate assistance, even if Registrar Corp is not designated as U.S. Agent for your facility. Simply phone: +1-757-224-0177 or contact via Live Help: https://regstaging.wpengine.com/livehelp