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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.

FSVP & VQIP: Two New Importer-Based Programs under FSMA

The FDA Food Safety Modernization Act (FSMA) requires U.S. FDA to create two new programs for importers:  the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP).  The new law does not detail specific requirements or processes of these two programs but requires U.S. FDA to outline these new requirements in upcoming regulations.

U.S. FDA must promulgate regulations to provide the specific content for FSVP by January 4, 2012, at the latest.  By this date, U.S. FDA must issue a guidance document to assist importers in developing foreign supplier verification programs.  FSVP requires importers to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported is produced safely, unadulterated, and not mis-branded.  An “importer,” for this program, is defined as the United States owner or cosignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States.  FSMA states that verification activities may include monitoring records for shipments, lot-by-lot certification compliance, annual on-site inspections, checking the hazard analysis and risk-based preventative control plan of the foreign supplier, and periodically testing and sampling shipments.  Importers are required to maintain records related to this program for two years and are required to allow a U.S. FDA inspector to review these records during an inspection.  U.S. FDA is required to publish and maintain a list of FSVP participants that will display, at a minimum, the name and location of suppliers in the program.  All of the new FSMA requirements for this program are required to be in place and functional by January 4, 2013.

On the other hand, VQIP is entirely voluntary.  U.S. FDA must, in conjunction with the Secretary of the Department of Homeland Security (DHS), establish this program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate.    VQIP will also establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in the program.  Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought, from a foreign country into the United States.  This is an important distinction from the definition of an importer under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program.  As with all new requirements under FSMA, the deciding factors will not be hammered out until the final regulations are issued.   Indeed, FSMA does not define details of entities that are or are not allowed to participate in VQIP, nor does is outline the specific benefits and advantages of participating.  FSMA merely states that importers may request to participate and that participation will provide an expedited review process.  VQIP regulations are not required to be finalized by the U.S. FDA until July 4, 2013.

Both the Foreign Supplier Verification Program and the Voluntary Qualified Importer Program identify importers as the front line of contact for food safety awareness and hazard prevention.  U.S. FDA has indicated that these two programs are of top priority amongst all new FSMA requirements as the two programs were key components discussed during U.S. FDA’s first series of Public Meetings.  As more insight is gained into industry’s requests regarding the new act, U.S. FDA will issue regulation and guidance, hopefully incorporating concepts learned during these Public Meetings.

Registrar Corp at the Food Safety Summit

Registrar Corp joined the largest gathering of food safety professionals at the 13th annual Food Safety Summit held in Washington, D.C.  This year, more than 1,400 experts and leaders were drawn to informational sessions to discuss emerging issues in food safety including cost-efficient food safety solutions, food code and food defense, sanitation issues, and training methods for food industry employees.

During the conference, Vice Presidents Thomas Fass and David Lennarz browsed the exhibitor space to network with colleagues in food safety and regulatory compliance, and offered their insights on maintaining healthy products and safe food handling practices.

Registrar Corp is privileged to attend dozens of tradeshows and exhibitions each year to share our expertise with industry professionals as well as strengthen our knowledge of best practices and current trends.  To talk with a representative from Registrar Corp at a tradeshow in your region, browse our tradeshow listings page and schedule a meeting.

FSMA Public Meeting on Preventative Controls

As with the series of Public Meetings held at the end of March 2011, last week’s Public Meeting focused on a particular aspect of the new Food Safety Modernization Act (FSMA) and offered the U.S. FDA an opportunity to listen and pose questions to industry leaders.  The day-long meeting held on Wednesday, April 20th, was focused on FSMA’s preventative control requirements.  Specific themes included: thresholds for small businesses; food safety documentation; and definitions of key terms, such as “low-risk,” “high-risk,” and activities that constitute on-farm manufacturing.

As Ms. Charlotte Christin of U.S. FDA explained, foodborne illness is a great public burden in the United States.  Almost 75% of seafood consumed in the United States is imported, as well as large portions of the vegetable and fruit products consumed Stateside.  It is therefore essential that food safety concerns be addressed.  Time-old hazards are now occurring in new matrices.  Couple that with the fact that our populace now has brand new food safety hazards that were unthinkable a hundred years ago, and it becomes clear that now, more than ever, U.S. FDA needs to take a preventative stance in controlling food safety hazards.

A major issue continually broached at this Public Meeting touched upon the government’s understanding of the difference between a small business and a large business.  As FSMA allows for U.S. FDA to differentiate between the two and possibly create two separate sets of regulations for the two groups, this difference is crucial.  Mr. Don Kraemer of the U.S. FDA explained that the administration may even create a tiered effectiveness timeline of requirements based on the size of the business, and may ultimately allow waivers for the very smallest of all businesses.  U.S. FDA was urged to create detailed guidance documents to help businesses understand their new requirements.

Food safety documentation was another issue raised in multiple forums and breakout groups.  While Mr. Don Kraemer explained that U.S. FDA expects that food safety documentation is already extensively created and kept among all food facilities, the question remains as to whether U.S. FDA will prescribe detailed requirements regarding timeframes, style, depth, and breadth of the records of the future.  The burden, again, seemed to rest on the shoulders of small businesses who claimed, at this Public Meeting, to have less resources to be able to comply with potentially too-prescriptive regulations.  Small businesses urged U.S. FDA to consider their fewer resources when writing regulations for required food safety documentation.

Another controversial topic rested among the various definitions of key terms.  Indeed, as FSMA mentions “high-risk” foods in multiple aspects, it is imperative to understand what U.S. FDA will see as “high-risk” and “low-risk” foods and processes.   Industry leaders were also curious as to what U.S. FDA will require as criteria and documentation for high-risk foods and feeds.     Basic, fundamental terms need to be clearly defined in order for industry to ensure its compliance with the new law and future regulations.

While U.S. FDA could not provide answers in this forum, one thing is clear: there is no shortage of questions.

Registrar Corp will continue to provide critical updates as the debate progresses.

David Lennarz and AMCHAM Vietnam host a seminar on U.S. FDA Import Requirements

Registrar Institute, the educational arm of Registrar Corp, gives more than 10 seminars each year around the world.  Earlier this month, Registrar Corp Vice President David Lennarz hosted an educational seminar for exporters and manufacturers in Vietnam to address U.S. FDA import regulations.  In partnership with the Vietnam office of the American Chamber of Commerce, Mr. Lennarz discussed a range of concerns that companies face when preparing their products for sale in the United States including product labeling, prior notice, U.S. Agent, and facility registration requirements.  Also addressed were the proposed requirements that international companies can anticipate according to the new Food Safety Modernization Act.  Understanding all of these requirements can seem daunting for manufacturers and exporters, and our informational sessions are thorough in clarifying the complicated, technical, and variable regulations.

Below you will find Part I of this seminar entitled How to Meet U.S. Food and Drug Administration (FDA) Import Requirements:

For more informational videos from this and other seminars, subscribe to our YouTube channel.  Similarly, if you would like to attend an informational seminar in your region and to have the opportunity to meet with Mr. Lennarz or any of the expert representatives at Registrar Corp, we provide a list of our upcoming sessions. Seminar registration is available at the Registrar Institute website.  Although Registrar Corp provides a complete menu of services to address the various concerns of food, beverage, drug, medical device, and cosmetic industry professionals, the seminars we provide are always instructional and are not given with the intent to promote our services.

U.S. FDA’s first set of Public Meetings to discuss FSMA

U.S. FDA held a series of Public Meetings during the week of March 28th.  The first focused on the import components of the Food Safety Modernization Act (FSMA) and the second on comparability considerations.  Both were held as an opportunity for U.S. FDA to gain insight from industry regarding best practices, current options, and future goals.

The import components of FSMA’s Title III proved to be largely undefined in the law as passed by U.S. Congress.  Therefore, the Public Meeting held on March 29th was an opportunity for U.S. FDA to listen to suggestions and requests from industry leaders and gain information to use when defining future regulations.  While no limit exists for written public input, which is due to U.S. FDA by April 29th, 2011, only a handful of industry leaders were able to gain speaking time during the one-day meeting.  Those able to speak included a broad range of leaders, including those from third-party certification bodies like ANSI-ASQ, the Global Food Safety Initiative (GFSI), and GlobalGAP.  During this meeting, U.S. FDA also hosted multiple breakout sessions wherein attendees could speak to U.S. FDA representatives in smaller groups focused on specific topics like the Voluntary Qualified Importer Program (VQIP), the Foreign Supplier Verification Program (FSVP), and Third-Party Certifications.  U.S. FDA also heard from panels representing state governments and foreign country governments.

Similarly to the vague language of the import components, the comparability requirements are also largely undefined in the new law.  The two-day Public Meeting, held from March 30 to March 31, was another opportunity for U.S. FDA to listen to the public’s opinions about how new regulations should be written regarding comparability of foreign governments.  This two-day meeting hosted multiple panels and included many speakers representing foreign governments, including Canada, New Zealand, Australia, and the European Union.  The U.S. FDA gave brief presentations on their past exploration in foreign government comparability test pilot programs and also heard from Ms. Mary Stanley, who spoke in detail about the USDA’s experience in certifying foreign governments in the agricultural sector.  U.S. FDA listened to opinions from the National Association of Specialty Food Trade (NASFT), the U.S. Trade Office, and the United States CODEX Manager.  In particular, the U.S. FDA asked many questions related to capacity building, registration of importers, particular details of comparability certification, and abilities of foreign governments to ensure that food is actually safe.

Over the three total days of Public Meetings, U.S. FDA heard varied and extensive opinions about how industry believes future regulations should be written.  While U.S. FDA has undeniably large questions to answer, no clear solutions were provided.  However, it is apparent that U.S. FDA has a valuable resource in the industry leaders that participated in this week’s event and had many options and concepts presented.  Additionally, U.S. FDA has already scheduled another Public Meeting for April 20th, 2011, to learn more about industry’s opinions on in-facility food safety and preventative protocols. It seems U.S. FDA is listening, and as always, Registrar Corp will be actively engaged in the discussion as it develops.

Next week, we will further explain the proposed Voluntary Qualified Importer Program (VQIP) and Foreign Supplier Verification Program (FSVP) changes and what they mean for exporters, manufacturers, and other food industry professionals.

For more information about this and future U.S. FDA Public Meetings, contact us at [email protected]