Registrar

Assistance with U.S. FDA Regulations

Drugs

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.

Top 10 Things Sunscreen Manufacturers Need to Know Before the FDA Compliance Deadline

With only 7 days until the deadline for compliance with U.S. Food and Drug Administration (FDA) OTC Sunscreen labeling regulations, Registrar Corp would like to remind industry of the regulation requirements.

On June 14, 2011, the FDA issued new rules for labeling and testing of sunscreen products. Also, U.S. FDA issued an additional proposed rule and a call for data concerning future rule making. These new rules present dramatic changes to past labeling requirements and a departure even from what U.S. FDA proposed in 2007.

To help industry make sense of the new rules, Registrar Corp has published the following “Top 10” highlight list of changes mandated for manufacturers of sunscreen products.
1. The new rules require relabeling of over-the-counter (“OTC”) sunscreen products.
2. Products must be in compliance by December 17, 2012. December 17, 2013 for products with less than $25,000 in annual sales.*
3. Drug listings on file with U.S. FDA must be amended to reflect the new labels.
4. U.S. FDA’s enforcement policy allows the following dosage forms for OTC sunscreen products: oils, lotions, creams, gels, butters, pastes, ointments, sticks. U.S. FDA has called for more data concerning sprays; they will be permitted pending further action, provided the sprays are labeled precisely as specified by U.S. FDA.
5. U.S. FDA’s enforcement policy does NOT allow certain dosage forms for OTC sunscreen products such as wipes, towelettes, powders, body washes, shampoos, etc.
6. The new rule forbids the use of certain active ingredients in OTC sunscreen products.
7. Sunscreen products must undergo SPF testing according to stringent testing methods specified in the new rules, and must be labeled differently depending on whether they are “Broad Spectrum” as determined by specified testing methods. Claims, warnings, and indications must be stated depending on the results of broad spectrum and SPF testing of the product.
8. Products that are determined to be broad spectrum and have an SPF value of 15 or greater by the specified testing methods may make claims concerning skin cancer and early skin aging, but only in the specific phrases authorized by the new rules. Non broad-spectrum products or broad spectrum products with SPF value of less than 15 may not make such claims, and are limited to claiming effectiveness against sunburn.
9. Products that claim to be water-resistant on the front label must specify effectiveness against sweating or swimming based on specified testing methods. Sunscreens that are not water-resistant must advise use of a water-resistant sunscreen after swimming or sweating. Sunscreens also cannot claim to provide sun protection for more that 2 hours without reapplication or provide protection immediately after application. The phrases “sunblock,” “sweatproof,” and “waterproof” are banned. U.S. FDA also proposes a new rule limiting SPF claims to “50+” or less.
10. For more information about U.S. FDA’s new sunscreen rules, contact Registrar Corp by telephone at +1-757-224-0177 or via live help at https://regstaging.wpengine.com/livehelp.

*Dates changed on May 11, 2012.

U.S. Marshals Seize Unapproved Drug Products Being Marketed As Supplements

U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), have seized multiple dietary supplement products from a Florida distributor (Globe All Wellness, LLC.) on the grounds that the products are unapproved new drugs and contain illegal and undeclared active pharmaceutical ingredients.

The distinction between dietary supplements and drugs is often confusing. A better understanding of the Federal Food, Drug, and Cosmetic Act (from which FDA derives its authority) can help clarify the situation. The Federal Food, Drug, and Cosmetic Act (FDCA) has specific regulatory definitions for “dietary supplement” and “drug.” FDCA defines “dietary supplement” as a product “intended to supplement the diet and contains one or more of the following: a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any the aforementioned; is intended for ingestion as a tablet, capsule, powder, softgel, gelcap, or liquid form, or if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet” (Sec. 201(ff)). Dietary supplements may not contain an ingredient authorized for investigation as a new drug, unless the ingredient was previously marketed in a dietary supplement or food. FDCA defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (Sec. 201(g)(1)). Drugs must be formally approved by FDA or be the subject of a monograph published by the agency’s OTC Drug Review Panel.

Dietary supplements are permitted to make specific claims related to the structure and function of the body. These “structure/function” claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, describe general well-being from consumption of a nutrient or dietary ingredient, or describe a benefit related to a nutrient deficiency disease. Generally, dietary supplements may make claims to support or maintain normal structure or function of the body, but cannot make claims to affect such structure or function. Claims that exceed what FDA considers appropriate for a dietary supplement can cause the agency to brand a product an “unapproved new drug.”

FDA had previously inspected a Globe All Wellness facility and found multiple violations related to these regulatory issues. The firm’s product labels include claims that exceeded those deemed appropriate for a dietary supplement (“deliver peak sexual experience”… “lose 20 pounds in a month!”). During the course of the inspection, FDA also tested the products and found undeclared active pharmaceutical ingredients: sibutramine (Meridia) and sildenafil (Viagra). Both had previously been approved by FDA as prescription drug active ingredients and therefore were inappropriate for use in a dietary supplement. In addition, Meridia had been pulled from the market due to safety concerns related to increased risk of heart attack and stroke. Seizure was deemed necessary to prevent misbranded and adulterated drugs from entering the market. As this situation shows, FDA will resort to aggressive enforcement actions in order to protect public health and ensure that food and drug regulations are followed.

In order to reduce the risk of FDA enforcement actions on their products, companies should consider having their dietary ingredients and labeling claims reviewed by Registrar Corp’s team of Regulatory Specialists. If you have questions regarding FDA compliant labeling and formulations for your particular product, simply contact Registrar Corp 24/7 via Live Help or call Registrar Corp’s U.S. Office at: +1-757-224-0177. To receive regular regulatory updates, follow Registrar Corp on Twitter: @RegistrarCorp

*Learn more about What Makes a Food a Dietary Supplement

Massachusetts Orders 11 Pharmaceutical Companies to Shut Down

Over the past several months, the U.S. Department of Health of the state of Massachusetts inspected a series of pharmaceutical compounding plants after an outbreak of fungal meningitis. Yesterday, Massachusetts officials ordered the partial or complete closure of 11 pharmacies.

These surprise inspections are linked back to a meningitis outbreak that occurred late last year. On December 12, 2012, U.S. Food and Drug Administration (FDA) and the Center for Disease Control (CDC) announced an outbreak of meningitis at a compounding center in Massachusetts. The New England Compounding Center has since shut down.

Since then, Massachusetts officials have conducted a series of inspections on pharmaceutical compounding plants. 11 of the inspected pharmacies were required to partially or completely shut down because of varying degrees of violations.[1]

Pharmacies that have been closed are required to submit plans for corrective actions and then pass re-inspections before they can begin producing drugs again.

In the past, compounding pharmacies were not completely regulated by the FDA. Pharmacies generally fall under state law. On November 14, 2012, the FDA asked Congress to grant FDA more power to regulate compounding pharmacies. Congress has yet to make a final decision. Currently, U.S. food safety laws do not provide a clear definition of “compounding” which limits FDA’s “ability to build a case against compounding pharmacies that fail to meet basic safety standards.”[2]

If you have any question about drug establishment registration and listings requirements or any FDA regulation, please contact Registrar Corp 24/7 at https://regstaging.wpengine.com/livehelp or call us at +1-757-244-0177.

 

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