Amid growing concerns over the safety of food and drug imports into the country, the U.S. Food and Drug Administration (FDA) recently released a plan to improve oversight and regulation of imported goods. The “Pathway to Global Product Safety and Quality” is part of the FDAs “new global strategy” under the Food Safety Modernization Act (FSMA) to monitor and inspect an increasing number of imports that cross into U.S. borders.

The FDA is responsible for overseeing the food, pharmaceutical and medical device products that enter into U.S. territory, as well as regulating the manufacturers and importers who produce these goods. The movement towards globalization and increased flow of capital, information, and goods across borders have put a strain on both the FDAs resources and ability to efficiently and effectively regulate the importation of goods. Over the next year alone, the FDA projects the number of shipments of FDA-regulated goods that will pass through the nations 300 ports of entry is expected to quadruple from 6 million to 24 million shipments.

This heavy influx of imported, globally-sourced goods has effectively created a regulatory nightmare for the FDA. In todays market, a product may move through different manufacturers or suppliers in multiple countries before reaching its final product stage or destination. Because goods are now entering the U.S. from new and different markets, the FDA is faced with the challenge to ensure that all entities in that multi-step chain comport with FDA regulations. The FDAs ability to sustain adequate regulatory functions has been impaired by these challenges.

In recent years, evidence of the FDAs struggle to keep up with the monitoring and regulation of imports has reached the publics eye. The New York Times published an article highlighting the FDAs failure to remove dangerous imported foods from the market. The article explained how the FDA failed to execute required audits or follow-up with companies about known contaminated food imports. Other events, such as heparin poisoning by a manufacturer, milk contamination, and counterfeit glucose monitoring strips, have put a spotlight on how the FDA has fallen short of its regulatory goals. As we blogged here earlier this year, the President even warned the FDA that it would likely be the target of a major overhaul due to its outdated processes and failure to keep up with advances in the rapidly changing market.

The new “Pathway to Global Product Safety and Quality” is the FDAs response to these mounting problems related to the importation of food and medical products. Under the FSMA, the FDA has a new mandate to require comprehensive, prevention-based controls. In addition, the FDA can now hold importers responsible for making sure that their foreign suppliers have adequate preventive controls to ensure the safety of foods shipped to the U.S. The FSMA also directs the FDA to inspect at least 600 foreign food facilities within the next year and to double the number of inspections every year for the next five years.

To help with the regulation of the medical device industry, the FDA has opened additional offices in key international locations and increased its number of foreign inspections. The FDA has also engaged in harmonization of drug regulation through the International Conference on Harmonization. In addition to working with Australia to create the Global Harmonization Task Force to expand the global regulation forum, the FDA also joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), which is an informal organization of drug manufacturing inspectorates from 39 countries.

As part of its transformation “from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders,” the FDA is in the process of developing an international operating model as part of the new “Pathway to Global Product Safety and Quality” plan. The four tenets of this approach are:

1. The FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
2. With these coalitions, the FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
3. The FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
4. The FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

This operating model aims to provide the FDA with the information sharing and technological tools necessary to regulate a global market and to ensure the safety of Americans.

The FDAs new, extensive global plans raise serious questions about implementation. Even though these plans demonstrate that the FDA recognizes the deficiencies in its current scheme and understands what needs to be done to improve the regulation of imported goods into the U.S., these plans hardly seem feasible. For example, under the current model, the FDA has had difficulties inspecting a few hundred facilities annually, yet the Agency is expected to execute 19,200 food facility inspections in the plans sixth year. Without significant increases to agency personnel or third-party contractors and the threat of a smaller budget this fiscal year, the FDA seems to lack the manpower and resources to accomplish the goals set forth by the FSMA and in the new “Pathway to Global Product Safety and Quality” plan. The FDA does acknowledge in its new plan that it “does not”nor will it”have the resources to adequately keep pace with the pressures of globalization” and that constrained federal resources will prove challenging to the fulfillment of its goals. Even if the new global initiatives are successful in alleviating some of the FDAs current problems, it is still unclear as to whether the FDA will be able to implement any changes that produce discernible results or increased protection of the publics safety.

Fuerst Ittleman will continue to monitor the FDAs progress regulating the importation of foods and devices. For more information, please contact us at contact@fidjlaw.com.

After decades of deliberation, the U.S. Food and Drug Administration (FDA) announced changes to the requirements for over-the-counter (OTC) sunscreen products. In 1978, the FDA began developing new rules for the regulation of sunscreen products. Now, over thirty years later, the FDA issued a Final Rule as part of its “ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness” for sunscreens sold without a prescription. The FDA issued four regulatory documents: a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Notice of Availability of Guidance Document for Industry (ANPR). The new requirements under the Final Rule will take effect by the summer of 2012.

After reviewing current scientific data, the FDA established a standard broad spectrum test procedure for OTC sunscreens and developed new labeling requirements for marketing sunscreen products. While the current rule focuses almost exclusively on protection against only ultraviolet B (UVB) radiation from the sun, the new Final Rule addresses protection against UVB rays and early skin aging and skin cancer caused by exposure to ultraviolet A (UVA) rays. This new standard broad spectrum test essentially measures the level of UVA radiation protection in relation to the amount of UVB radiation protection. Products are required to pass this broad spectrum test in order to be labeled as “Broad Spectrum” sunscreens. This new designation is intended to help consumers make more informed decisions when selecting sunscreens.

The new rule will also affect the labeling of “Sun Protection Factor” (SPF), the value that indicates the overall amount of protection provided by sunscreen, and claims for use. When used as directed, “Broad Spectrum” sunscreens with SPF values above 15 can help to protect against sunburn, skin cancer, and early skin aging. Under the FDAs new Rule, only these products may claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Products with SPF values below 15, however, are prohibited from using “Broad Spectrum” on their labels and can only claim to help prevent sunburn.

In addition to “Broad Spectrum,” SPF, and use claims labeling, the Final Rule also outlines requirements for water resistance claims and “waterproof,” “sweatproof,” or “sunblock” claims. The new labeling rules will require manufacturers to indicate on the front label whether the sunscreen product is effective for 40 minutes or 80 minutes while swimming or sweating, or if the product is not water resistant, to direct consumers to use a water resistant sunscreen if swimming or sweating. The Rule provides that sunscreen manufacturers cannot label products as “waterproof,” “sweatproof,” or identified as a “sunblock” because these claims “overstate their effectiveness.” As part of the new labeling requirements, manufacturers will also be required to include drug facts on their labels, which will provide consumers with easy access to the products active and inactive ingredients and detailed directions on proper usage.

The FDA is also interested in obtaining additional information and data about sunscreen in other dosage forms, such as sprays, lotions, oils, sticks, gels, butters, ointments, creams, and pastes. The FDA seeks information about the safety and effectiveness of these alternative dosage forms of sunscreen because “the record (data and information) about sunscreens in spray dosage forms is not comparable to that for sunscreens in other dosage forms.” The ANPR serves as an invitation to the public to comment on regulations the FDA may pursue in its future rulemaking.

By creating regulations that require testing and limit misleading claims, the FDA has demonstrated its increased effort to strengthen labeling regulation of sunscreen products. Despite these improvements, some continue to question whether the FDA could have done more. Advocacy groups, like Environmental Working Group (EWG), continue to pressure the FDA to further tighten safety standards for sunscreen products sold in the United States. “The Agencys weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” a representative of EWG said. EWG claims that the FDAs rule is not stringent enough and that “about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.” According to the FDA, however, “the ingredients in sunscreens marketed today have been used for many years and the FDA does not have any reason to believe these products are not safe for consumer use.” The FDA is currently reexamining the safety information available for active ingredients included in sunscreens marketed today.

The FDAs decision to make changes to the labeling and testing of sunscreen products comes less than one year after it released a Consumer Health Information publication warning about the dangers of exposure to devices such as sunlamps and tanning beds. As we reported here, the FDA announced its concern about the use of both UVA and UVB radiation in tanning salons because of the known risks associated with exposure, such as skin damage, early skin aging, and skin cancer. These concerns are the very same ones that prompted the FDA to make labeling changes to sunscreen products this year. While the FDA has yet to release new regulations governing sunlamps and tanning beds, the new changes to sunscreen product labeling may serve as an indication of the FDAs shift towards stricter oversight and regulation of products and devices associated with UVA and UVB exposure.

Fuerst Ittleman will continue to monitor the FDAs rules for labeling and effectiveness testing of sunscreen products and other products or devices related to UVA or UVB exposure. For more information, please contact us at contact@fidjlaw.com.

On April 14, 2011, the U.S. Government Accountability Office (GAO) reported that the U.S. Food and Drug Administrations (FDA) seafood oversight program, which ensures the safety of all imported seafood, is “limited” and needs improvement. In response to the GAO report, Congresswoman Rosa DeLauro (D-CT) announced her support for increased funding and better oversight for seafood to protect the public. DeLauro demanded that we “ensure that the FDA has the additional resources needed to be successful at their mission in ensuring the safety of these products and the protection of the American public.”

Currently, 80 percent of all seafood consumed in the U.S. is imported, and half of all imported seafood is farm-raised. However, due to the high rates of infection associated with raising fish in farms, farmers find it necessary to treat their fish with drugs, such as antibiotics and antifungal agents, which creates a potential risk of drug residue for consumers.

Concerned with the safety and increasing quantities of imported seafood, DeLauro emphasized that “only one in every ten imported fish, shellfish, shrimp, or other seafood is tested for drug residues when it enters our country.” The FDA tests for residue of 16 unapproved drugs, in comparison to the European Union (EU) which tests for residue of as many as 50 drugs. The GAO recommended that the FDA should study the feasibility of adopting other practices, such as developing a national residues monitoring plan to control the use of aquaculture drugs to ensure the safety of imported seafood.

The GAO also found that sampling of imported seafood was inadequate. The FDA collects approximately 0.1 percent of imports for sampling, a very limited number. The EU samples as much as 4 percent of seafood imports. The GAO proposed that the FDA develop a more comprehensive import sampling program effectively using its laboratory resources. Currently, the FDA only utilizes 7 of 13 available laboratories for seafood drug residue testing. Additionally, the GAO found that the FDA should take into account the imported seafood sampling programs of other entities and countries.

The GAO further discussed that FDA inspectors do not typically visit foreign aquaculture farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In China, the FDA has only inspected 1.5 percent of seafood processing facilities in the last 6 years. The GAO noted that the FDAs assessment is limited by the lack of procedures, criteria, and standards. In contrast, the EUs inspection includes a review of the government structure, food safety legislation, and the foreign countrys own inspection program. The GAO recommended developing a strategic approach with specific time frames to enhance the current inspection program.

Fuerst Ittleman will continue to monitor the FDA for implementation of changes to the seafood oversight program. For more information, contact us at contact@fidjlaw.com.

In January of 2007 the U.S. Food and Drug Administration (FDA) proposed a definition for the term “gluten-free,” and three years later there is still no regulation regarding the term. Regulations for gluten-free labeling would help those who suffer from celiac disease, a chronic inflammatory disorder of the small intestine which is triggered by certain proteins known as gluten. Approximately 1 percent of the population suffers from celiac disease. Glutens are naturally present in certain cereal grains and form when wheat flour is mixed with liquid and kneaded. Grains that contain gluten are wheat, rye, barley, cross-bred hybrids, and possibly oats.

Currently, a label with the term “gluten-free” must be truthful and not misleading; however, there is no set definition provided by the FDA. The FDA has proposed that a food which bears the label “gluten-free” must not have more than 20 parts per million or more of gluten, which is the amount that can be reliably detected. The use of the label would be voluntary, meaning foods that are naturally gluten-free, such as milk or water, would not have to bear the label. Foods that would be prohibited from bearing the label are those which include barely, common wheat, rye, spelt, kamut, triticale, farina, vital gluten, semolina, and malt vinegar. Other countries such as Canada, Brazil and the Codex Alimentarius Commission, an joint international FAO/WHO standards organization, have defined gluten-free as having no more than 20 parts per million of gluten present.

Recently, the owner of Great Specialty Products in North Carolina was sentenced to 11 years in prison after he was found guilty of purchasing regular bread and rolls and repackaging them as gluten-free. Dozens of people complained of illness after consuming the goods.

Hopefully, the FDA will not take as long to define the term “gluten-free” as it took the U.S. Department of Agriculture (USDA) did to define the term “organic.” CNN reported in 1997, seven years after the Organic Foods Production Act of 1990, that USDA officials had finally drafted a set definition for organic.

On May 4, 2011, activists seeking to pressure the FDA to define gluten-free brought a 13-foot-tall gluten-free cake to Capitol Hill. In the absence of a federal standard, it is buyer beware.

Fuerst Ittleman will continue to monitor the FDA for changes to gluten-free labeling requirements. For more information, contact us at contact@fidjlaw.com.