24/7 Live Chat Call Us

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.


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

New Guidance Documents and Interim Final Rules under the Food Safety Modernization Act

Since the U.S. FDA Food Safety Modernization Act (FSMA) was passed earlier this year, U.S. FDA has released a handful of new mandated publications relating to food safety and imported food within the past few weeks: an updated Fish & Fisheries Products Hazards & Controls Guidance, an interim final rule for the administrative detention of food, and an interim final rule for the prior notice of refused imported food shipments.

The Fish & Fisheries Products Hazards & Controls Guidance is also known as the Seafood HACCP Guidance Document.  It was last updated in June 2001 and was recently re-issued in its fourth and most current version on April 27, 2011.  This guidance document clarifies the regulations in 21 CFR Part 123, which support the safe and sanitary processing of seafood products.  The newest version contains many changes from the third edition, such as an increase in the number of steps in creating a HACCP Plan from thirteen to eighteen; a final version of the Glass Inclusion chapter; and multiple new appendices for specialty concerns such as Japanese and Hawaiian vernacular names for sushi, bacterial and viral pathogens most concerning to public health, and extra procedures for the importation of seafood products.  While the new document may create additional work for some seafood processors, manufacturers must know that meeting U.S. FDA seafood HACCP requirements exempts the seafood processor from two new requirements that were instituted for all food manufacturers.  Seafood processors meeting U.S. FDA seafood HACCP requirements do not need to participate in the Foreign Supplier Verification Program (FSVP) and have, by definition of meeting seafood HACCP requirements, already met new HACCP requirements placed on all food manufacturers.

The interim final rule for the administrative detention of food was issued late last week on May 4, 2011, and clarifies that U.S. FDA, starting on July 3, 2011, will be able to detain food that the agency believes to have been produced or processed in unsanitary conditions.  This is a huge endowment of power as U.S. FDA was previously only able to accomplish this by working with state governments or for products for which unsanitary processing conditions could be proven.

The interim final rule for the prior notice of refused imported food shipments was issued late last week on May 4, 2011, and details that anyone importing food into the United States must declare to U.S. FDA if that same product has ever been denied entry into another country.  This new information will be submitted when a country completes Prior Notice, which is a program that was established in 2002 under the Bioterrorism Act.  The interim final rule states that this change can help U.S. FDA be better informed about potential risks of imported food products.

All of these new provisions allow both U.S. FDA and food manufacturers to be better prepared to prevent hazards and unsafe food, which directly support FSMA’s goal of a safe food supply.

A more in-depth analysis of these three new publications will be forthcoming.  Stay tuned.

Registrar Corp Now Offers Services for Radiation Emitting Devices

Registrar Corp now provides Reporting, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Radiation-Emitting Electronic Device Industry.

The U.S. FDA regulates Radiation-Emitting Electronic Devices intended for use in the United States by humans or other animals. U.S. FDA defines Radiation-Emitting Electronic Devices as “any product that contains an electronic circuit and generates any kind of radiation.”  Radiation-Emitting Electronic Devices are manufactured or assembled products (or component, part, or accessory of such product) which, when in operation, contain or act as part of an electronic circuit and emits (or in the absence of effective shielding or other controls, would emit) electronic product radiation. “Electronic product radiation” is defined by the U.S. FDA as any ionizing or non-ionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

Examples of Radiation-Emitting Electronic Devices may include, but are not limited to, microwave ovens, televisions receivers and monitors, video displays, lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, or laser CD players.

Some Radiation-Emitting Electronic Devices, such as diagnostic x-rays, ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, or ultraviolet dental curing devices, are regulated by the U.S. FDA as both a Radiation-Emitting Electronic Device and as a Medical Device.

For information about how your product is regulated by the U.S. FDA, contact us and one of our expert regulatory advisers will assist you.

Registrar Corp attends the China International Medical Equipment Fair (CMEF)

Last week, employees from our Registrar Corp – China office location attended the China International Medical Equipment Fair (CMEF) in Shenzhen, China. China International Medicinal Equipment Fair (CMEF), founded in 1979, is the largest exhibition of medical equipment and related products and services in the Asia-Pacific region. Among the crowd of over 5,400 exhibiters and 100,000 participants, our representatives from China had the opportunity to meet prospective clients face-to-face and promote our services to Medical Device processors, exporters, and manufacturers eager to expand their businesses to the United States market.

If you would like a one-on-one consultation with an expert adviser about your product or service, visit our tradeshows and exhibitions page to schedule a meeting.

FSMA’s Next Steps

Since the Food Safety Modernization Act (FMSA) was signed into law earlier this year on January 4, 2011, U.S. FDA has already implemented significant changes to structural processes and consumer outreach.  As mandated by Congress, U.S. FDA has begun the process of establishing and setting re-inspection fees, created a consumer-friendly website focused on food recalls, and submitted a report to Congress concerning State and local recall authority.  While these are, without question, important changes, many more considerable changes are coming that will impact industry.

Later this week, on May 4, 2011, U.S. FDA is mandated to issue interim final rules concerning Administrative Detention of Food and Prior Notice of Imported Food Shipments.  These rules will be published in the Federal Register and Registrar Corp will analyze and post key points of the regulations in future articles.

A month later, on July 3, 2011, U.S. FDA has a long list of items to have completed.  On this date, U.S. FDA will be empowered to suspend food facility registration for facilities that created, caused, or were responsible for food having a reasonable probability of having adverse health consequences to humans or animals, as well as facilities that knew or had reason to know of such probability yet still packed, received, or held such food products.  No person is given permission to ship food from facilities with suspended facility registration nor introduce such food into United States commerce.  U.S. FDA may extend suspension of food facility registration until it has been determined by U.S. FDA that adequate grounds for suspension no longer exist.  These facilities may have further requirements to meet because of their suspension, such as possibly needing to submit corrective action plans to U.S. FDA.

On July 3, 2011, U.S. FDA must also issue multiple guidance documents and update older guidance documents.  U.S. FDA must issue a small entity compliance guide for facility registration as well as contaminant-specific and science-based guidance documents regarding action levels, tolerances, or regulations, based on studies to be conducted at least every two years moving forward.  The “Fish & Fisheries Products Hazards and Controls Guidance” must also take these changes into account, in addition to technology advances that have occurred since its previous publication.  U.S. FDA must publish a guidance document that clarifies when a new dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor must document the new dietary ingredient, and the appropriate methods for establishing the identity of the dietary ingredient.

In addition to the guidance documents required on July 3, 2011, U.S. FDA must complete several other tasks.  U.S. FDA must report on the progress made in implementing a national food emergency response laboratory network in conjunction with efforts by the United States Department of Agriculture (USDA), Department of Homeland Security (DHS), and State, local, and tribal governments and must be made available on the U.S. FDA website.  The U.S. FDA and USDA must also establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance.  A diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, including food retailers, food manufacturers, consumer organization, and academia, must be established to make recommendations to the Secretary of Health and Human Services regarding designations of the Centers for Excellence, which must be established later in the year.  U.S. FDA must also develop and implement, by this date, a strategy to better identify smuggled food and prevent the entry of such food into the United States in conjunction with DHS.

FSMA imposes several important tasks upon U.S. FDA within a relatively short deadline.

Registrar Corp will keep you abreast of these issues as they develop.  For specific questions about FSMA, contact Registrar Corp’s team of knowledgeable Regulatory Specialists via Live Help 24/7.