Pursuant to the Food Safety and Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) is required to meet various deadlines for the implementation of new food safety systems. July 3, 2011 marked 180 days since President Obama signed the FSMA into law as well as the deadline for completing the new dietary supplement ingredient guidance and an anti-smuggling strategy. On July 5th the FDA announced it had completed two tasks required by the FSMA.

New Dietary Supplement Ingredient Guidance

The first task completed by the FDA was issuing the draft guidance intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary. Manufacturers of dietary supplements are required to notify the FDA in advance, through a premarket safety notification, when adding a new ingredient with an unknown safety profile to their products. Manufacturers must also provide evidence that the ingredient is safe for consumers.

It appears that the agencys regulatory interpretation of NDIs is more restrictive than the statutory language, thus creating substantial hurdles for manufacturers. The draft guidance provides what specifications should be included in an NDI, such as the type and amount of evidence, in order to establish that a dietary supplement is “reasonably expected to be safe.” 21 USC §350b(a)(2). The draft guidance consists of more than 120 Q&As regarding the determination of, whether a dietary ingredient is an NDI, whether a notification is required, and what information should be included in the notification.

The draft guidance also states that the FDA will alert the Drug Enforcement Administration (DEA) if a notice is deemed inadequate because the ingredient is an anabolic steroid or a material with the same chemical qualities.

The FDA is currently seeking public comment on the draft guidance; the deadline for submission is October 3, 2011.

Anti-Smuggling Strategy

The second task was the development of an anti-smuggling strategy. The Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) developed the new anti-smuggling strategy in order to identify and prevent the entry of smuggled food into the U.S. that could be dangerous to national security and consumer safety. HHS and DHS are working closely with Customs and Border Protection (CBP) and Immigration and Customs Enforcement (ICE) to identify import shipments that could conceal undeclared foods.

Food may be smuggled for many reasons including economic gain, to evade import taxes, evade routine inspection that could raise safety concerns, or for more dangerous reasons, including plots to intentionally harm the American public. The strategy will focus on imported foods that pose a significant public health threat.

Fuerst Ittleman will continue to monitor the implementation FSMA food safety goals. For more information on the FSMA, regulation of dietary supplements, or the anti-smuggling strategy, please contact us at contact@fidjlaw.com.

Last week, the U.S. Food and Drug Administration (FDA) announced the release of a guidance document for in vitro companion diagnostic devices. According to the FDA, companion diagnostics are “tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give.” These diagnostic tests enhance the effectiveness of targeted treatments because they help to determine whether a patient is a genetic fit for a particular therapy. The guidance document clarifies the definition of a companion diagnostic and also provides guidance on the agency’s proposed policy for reviewing in vitro diagnostics and corresponding targeted therapies. The FDA is seeking public input on the draft guidance for 60 days.

The release of this new guidance document marks a significant change in the way the FDA has regulated these types of technologies. In particular, the guidance document signals a shift in the FDA’s regulation of companion diagnostic devices from enforcement discretion to risk-based oversight. The FDA intends to use the same risk-based process it uses to regulate all other medical devices, where the device’s regulatory pathway is determined by the level of risk to patients based on the device’s intended use and any concerns pertaining to its safety and effectiveness. Diagnostic devices will require submission of a premarket approval (PMA) or 510(k) premarket notification.

The FDA suggests that manufacturers should engage the FDA in the early stages of developing their products. The Agency also recommends that manufacturers develop therapeutic products and companion devices contemporaneously to facilitate the acquisition and review of clinical performance and clinical significance data. The guidance document suggests that the FDA will only approve targeted treatments after the corresponding companion device has gained FDA approval or clearance. The FDA outlined two exceptions where it may approve a targeted therapy before a companion diagnostic is approved: 1) when the therapy is intended to treat a serious or life-threatening disease or 2) where a condition has no available or satisfactory treatment and the potential benefits outweigh the risk of not having a cleared or approved companion device. In those cases, the FDA may approve a targeted therapy and clear or approve the device at a later time.

The FDA’s proposed guidance document for in vitro companion diagnostic devices raises interesting questions about how the FDA will continue to regulate similar types of industries, such as laboratory-developed tests (LDTs), where the FDA currently exercises enforcement discretion. While it is unclear whether the FDA will make changes to other industries that utilize similar technologies, the proposed guidance for FDA regulation of a companion diagnostic may be an indication that the FDA is moving away from enforcement discretion and is shifting toward a preference for a risk-based regulatory scheme.

Fuerst Ittleman will continue to monitor the progress of the FDA’s regulation of therapeutic and diagnostic devices. For more information, please contact us at contact@fidjlaw.com.

On July 5, 2011, regulators from the worlds food safety regulatory agencies gathered at the Codex Summit in Geneva, Switzerland to vote on food labeling guidance for genetically modified foods. Genetically modified foods (“GM foods”), food products derived from organisms whose genetic makeup have been altered through genetic engineering, have been on the international market since the early 1990s. This annual summit was organized by the Codex Alimentarius Commission, a body created in 1963 by the Food Agriculture Organization and World Health Organization to develop international food standards, guidelines, and related texts. Representatives from over 100 countries attended the Summit and approved GM food labeling guidance, which allows countries to label genetically modified foods without risking violation of international free trade laws.

After a 20-year struggle among international food safety bodies, the United States surprised attendees of the Codex Summit by ending their opposition to the proposed GM food labeling guidance. The United States has traditionally opposed GM food labeling because it believes GM food products on the market have been sufficiently tested and deemed safe for human consumption. Nevertheless, the United States changed its position because “this adopted text clarifies that foods derived from modern biotechnology are not necessarily different from other foods simply due to their method of production.” The United States, however, remains opposed to proposals that make GM food labeling mandatory.

As a result of the affirmative vote at the Codex Summit last week, the GM food labeling guidance document will become an official Codex text. Because national measures based on Codex guidance or standards cannot be challenged as a barrier to trade, the passage of this new guidance provides any country the freedom to adopt the new labeling system without the threat of legal sanctions from the World Health Organization.

By passing these new labeling guidelines, countries will now have the opportunity to conduct post-market monitoring of the effects of GM food products on the publics health. Countries that adopt the labeling guidance can better track information about GM foods because consumers can report any allergies or adverse reactions from exposure to foods containing GM products or foods derived from modern biotechnology. The Food and Drug Administration (FDA) is responsible for regulating food products that are sold on the market in the United States, whether produced domestically or imported from foreign nations. Even though the new labeling guidance requires new national legislation to refer to the “scientific uncertainty of risks” and the need for post-market surveillance, the new guidelines “will probably have little effect on food labels in the U.S. for the foreseeable future,” the LA Times reported. Consumers may slowly begin to see some changes to labels on imported food products, but the FDAs regulatory processes will likely remain unchanged unless the United States adopts the GM food labeling guidelines.

Fuerst Ittleman will continue to monitor changes to the regulation of genetically modified food products. For more information, contact us at contact@fidjlaw.com.

Researchers in Hong Kong reported discovery of a type of “super cancer stem cells” last week. These stem cells are embedded in liver cancers and are resistant to chemotherapy allowing them to spread to other body parts even after they are surgically removed. The discovery was published in the journal Cell Stem Cell.

According to the study, these cancer stem cells have a unique surface protein called CD24 and patients with high counts of this protein have lower changes of survival. The animal study used in the research demonstrated that mice implanted with liver cancer enriched with CD24 cancer stem cells were resistant to chemotherapy.

Liver cancer stem cells are particularly troublesome because they are responsible for growing tumors. These tumors can spread and become drug-resistant which causes recurrence even after the tumors are removed surgically. According to a report in Reuters, there are 500,000 new cases of liver cancer worldwide every year and over 50 percent of those new cases occur in China.

Chinas regulation of stem cell research is relatively relaxed when compared to that of the United States. According to some experts in the industry, China has used its laws and policies to position itself to become a global leader in the stem cell research industry. Unlike the United States, which has created confusing, muddled policy on stem cell research and therapies, China seems to be embracing the technologies and treatments that can originate in stem cell research.

Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to stem cell therapies and devices in the United States. For more information about the current regulatory framework surrounding stem cells or any other stem cell-related issues you may be facing contact us at contact@fidjlaw.com.