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FDA Revised Guidance on Marketed Unapproved Drugs

On September 19, 2011 the FDA issued a revised guidance on marketing unapproved drugs. Previously under CPG 440.100, unapproved new drugs that were on the market illegally for any number of reasons were removed from the market in an orderly approach.

The revised CPG 440.100 now clarifies that any unapproved drugs entering the market after September 19, 2011 will be “subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.” Drugs that are on the market as of September 19, 2011 will continue to have the regulation of the 2006 CPG 440.100 applied which will give a higher priority to high-risk categories.

FDA Revised Guidance If you have further questions about listing your drug product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates

FDA Guidance for Expediting Entry Review Process

On September 6, 2011 the Food and Drug Administration issued a letter with recommendations to help expedite the entry review process for medical and non-medical radiation-emitting electronic products. In this letter the FDA has noted that Affirmation of Compliance (AofC) codes should be provided at the time of entry to the U.S. and that appropriately submitted AofC codes will not only expedite the admissibility process but will also increase the likelihood that your shipment is not held for further entry review by FDA personnel.

In this letter the FDA has asserted that importers of these products work very closely with their brokers, filers, and other import personnel to verify that the information submitted is accurate and that the correct product codes are entered. The FDA has warned that “inaccurate or inconsistent data may lead to delays”. Furthermore, the AofC codes should be submitted with the relevant qualifier to the FDA and U.S. Customs and Border Protection.

Additionally, CBP regulations compel importers to note whether or not their products comply with federal performance standards. The FDA works with CBP by providing Form  FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be filled out by the importer. Moreover, radiation-emitting devices are also subject to regulation by the Center for Devices and Radiological Health (CDRH) and are subject to federal performance standards. However, there are medical radiation-emitting electronic products that have reporting requirements under 21 CFR 1002 but are not subject to federal performance standards, in which case, Form FDA-2877 is not required.

On the whole, importers, brokers, filers, and other import personnel should take extra care to ensure correct AofC codes that are applicable to medical devices and radiation-emitting electronic products. If you have further questions about importing your medical and non-medical radiation-emitting electronic product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates

FDA Announces Two Pilot Projects

The Food Safety Modernization Act (FSMA) was signed in to law January 4, 2011 and scheduled to be implemented over the next few years. In this law the FDA was mandated to create at least two pilot projects involving produce and processed foods. The FDA was also tasked with establishing record-keeping requirements to aid in the tracing of high-risk foods. On September 7, 2011, the FDA issued a press release stating it’s intent to implement the mandated pilot projects and their purposes.

The FDA will work with the Institute of Food Technologists (IFT), a non-profit scientific society, to establish these pilot programs under an existing contract with the FDA. The programs are expected to evaluate different methods and technologies for the most rapid and effect tracing of foods. It will also evaluate what types of data are most important, ways to connect various points in the supply chain and methods to ensure that the data is made more readily available to the FDA.

Throughout the pilot programs, key stakeholders will be able to provide input and the FDA has acknowledged that it will make efforts to also include those representing the food supply chain, such as farms, restaurants and grocery stores. Michael R. Taylor, FDA Deputy Commissioner for foods, stated that they will also consider what is most practical for various sized facilities.

In all, the pilot projects aim to enhance the FDA and industry’s ability to trace foods responsible for foodborne illnesses. After the projects are complete, more data will be gathered and the FDA will issue, as mandated, proposed regulations on record-keeping. They are also slated to define high-risk foods by considering known and potential risks of contamination and illness. Registrar Corp will continue to post new developments and is available for discussion  by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates

Registrar Corp at Africa Big 7 and Intervitis Interfructa

Registrar Corp met with hundreds of exhibitors and attendees at the Africa Big 7 Show and Intervitis Interfructa 2011 show in Capetown, South Africa this week.    Registrar Corp enjoyed meeting prospects and learning more about the specific concerns of the African exporters.

Registrar Corp, in particular, enjoyed spreading recent news of the FDA Food Safety Modernization Act to attendees and exhibitors.  For more information on Food Safety Modernization Act Requirements, visit Registrar Corp’s FSMA Article Archive at http://fda-news.registrarcorp.com/category/food-beverages/fsma/

If you would like to meet Registrar Corp at an upcoming exhibition, view our schedule here:  http://www.registrarcorp.com/exhibitions/

Food Safety Fees from U.S. FDA

Earlier this week, U.S. Food and Drug Administration (U.S. FDA) proposed food safety-related fees for the 2012 fiscal year.  The Food Safety Modernization Act (FSMA) enables U.S. FDA to collect user fees when a food facility is re-inspected or when U.S. FDA resources are used to verify a food recall.  The proposed food safety fees would be effective October 1, 2011 through September 30, 2012.  These food safety fees, according to FSMA, will be invoiced to domestic food facilities directly and to U.S. Agents of foreign food facilities.

Rates for re-inspection fees were posted as a notice in the Federal Register earlier this week at the following rates:

  • US $224 per hour for staff working on domestic food facilities
  • US $325 per hour for staff working on foreign food facilities

Re-inspection rates, which are expected to cover inspectors’ hourly rates and administrative tasks, laboratory testing, and travel expenses, are to be collected only in certain instances.  U.S. FDA has proposed that these food safety fees be collected when a previous inspection finds significant public health threats which required regulatory action.  If the firm can supply sufficient proof that the manufactured food product was not adulterated nor misbranded, U.S. FDA may not collect the fees, according to the notice.

When generating these proposed fees, U.S. FDA considered extensive research regarding both historical and expected costs of inspecting food facilities worldwide.

Industry may comment on this notice until October 31, 2011 as comments will be considered when U.S. FDA defines 2013 user fees.

2011

FDA Food Safety Modernization Act (FSMA) Discussed at D.C. Event

The 2011 Summer Fancy Food Show’s new location in Washington, D.C. proved to be a successful trade show venue for thousands of exhibitors, including Registrar Corp.  Exhibitors met with an estimated 30,000 visitors throughout the three-day event.  Popular food trends this year included specialty olive oils, candies, gourmet salts, and litchi-flavored products.  Jams, sauces, and coffees were also featured at several booths.  Registrar Corp utilized the Fancy Food Show to discuss U.S. FDA’s new Food Safety Modernization Act (FSMA) with attendees to ensure that all were aware of U.S. FDA’s new law and its implications on both large and small businesses.  If you need assistance understanding the FDA Food Safety Modernization Act, contact Registrar Corp at http://www.registrarcorp.com/livehelp

For more information on Food Safety Modernization Act Requirements, visit Registrar Corp’s FSMA Article Archive at http://fda-news.registrarcorp.com/category/food-beverages/fsma/

U.S. FDA implements new authorities, from Anti-Smuggling to Administrative Detention

On July 3rd, 2011, U.S. FDA gained official power to suspend registration of food facilities and also extended capabilities to administratively detain food.  The agency also introduced new required questions to the Prior Notice System.  Additionally, U.S. FDA announced an anti-smuggling strategy and draft guidance on new dietary ingredients.  All of these recent developments stem from the FDA Food Safety Modernization Act (FSMA), which was signed into law earlier this year.

U.S. FDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals.  U.S. FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States.  Registration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist.  U.S. FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.

Similarly, U.S. FDA’s new extended power of administrative detention of food shifts the previous detention paradigm and allows U.S. FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.   If U.S. FDA suspects food to have been produced or processed in unsanitary conditions, U.S. FDA may administratively detain food products for up to 30 days.

In an effort to be more proactive, U.S. FDA has also introduced new requirements for Prior Notice filings.  In the new system, U.S. FDA will require filers to indicate whether a food product has ever been refused entry to another country, and, if so, which countries.  U.S. FDA claims this will help the agency target higher risk products and regions.

U.S. FDA’s newly released anti-smuggling plan also portrays the agency’s move towards prevention of unsafe foods being sold and consumed in the United States.  The anti-smuggling strategy was developed in coordination with the U.S. Department of Homeland Security’s Customs and Border Protection (CBP) and reviews critical data indicative of products and regions which require a higher level of scrutiny.  U.S. FDA plans to share information with CBP to assist in deterring food smuggling.

Alongside the preventative measures detailed above, U.S. FDA has also been tasked via FSMA with generating several new Guidance Documents.   One such new Guidance Document that was published earlier this week is the draft guidance on new dietary ingredients.  While the final version is yet to come, this draft guidance reviews the methods in which a manufacturer wishing to use a dietary ingredient should notify the U.S. FDA before adding such ingredients to products.  This new requirements aims to protect consumers from unnecessary public safety concerns from new dietary ingredients with unclear health risks.

While this has been a busy week for U.S. FDA, the agency has many, many more tasks to complete in order to fully implement the new law.  Registrar Corp will continue to post new developments and is available for discussion 24/7 by phone at +1-757-224-0177 or via online Live Help.  To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates

U.S. FDA Purges Outdated Drug Establishment Registrations

The U.S. Food and Drug Administration (U.S. FDA) has purged out-of-date drug establishment registrations, which means any drug establishment registration that has not been updated for 2010 is no longer registered with the U.S. FDA.  Establishments in which drug products that are manufactured, stored, or labeled and are  intended for use in the United States are required to be registered with the U.S. FDA.  Drug establishment registration is required to be updated annually per U.S. FDA regulation.   Drug products sold in the United States that were manufactured, stored, or labeled in an establishment that has no current registration with the U.S. FDA are considered adulterated.  Companies selling these adulterated drug products are subject to extensive fines and legal penalties.

To ensure your drug establishment is still currently registered with the U.S. FDA, visit: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

For assistance with drug establishment registration, visit http://www.registrarcorp.com/fda-drugs

The U.S. FDA regulates drugs products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of humans or animals.  Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.

Registrar Corp at CPhI China 2011

After meeting thousands of prospects, the CPhI China show is now over.  For three days, Registrar Corp met with pharmaceutical companies all over the world and answered questions in reference to compliance with U.S. FDA drug regulations.  Ms. Cornelia Rooks, Senior Regulatory Specialist, gave a seminar focused on U.S. FDA drug requirements to about 50 attendees.   The trade show was extremely busy and the Registrar Corp booth had many visits from manufacturers, exporters, and others in the drug industry.

The U.S. FDA regulates drugs products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of humans or animals. Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.

If you would like to meet Registrar Corp at an upcoming exhibition, view our schedule here:  http://www.registrarcorp.com/exhibitions/

Top 10 Things Industry Needs to Know About U.S. FDA’s New Rules for Sunscreen Products

On June 14, 2011, U.S. FDA issued new rules for labeling and testing of sunscreen products.  In addition to the new rules, U.S. FDA issued an additional proposed rule and a call for data concerning future rulemaking.  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 June 18, 2012 (June 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 www.registrarcorp.com/livehelp