FSMA Checklist: Dietary Supplement Guidance and Anti-Smuggling Strategy

Jul 19, 2011   

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The first task completed by the FDA was issuing the draft guidance intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary.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 The draft guidance provides what specifications should be included in an NDI, such as the type and amount of evidence, in order to establish that a dietary supplement is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 The draft guidance consists of more than 120 Q&As regarding the determination of, whether a dietary ingredient is an NDI, whether a notification is required, and what information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The draft guidance also states that the FDA will alert the Drug Enforcement Administration (DEA) if a notice is deemed inadequate because the ingredient is an anabolic steroid or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The FDA is currently seeking public comment on the draft guidance; the deadline for submission is October 3, 2011.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.