As discussed in the Draft Guidance, although plasma derivatives, including albumin (a protein derived from human blood plasma) and products containing plasma-derived albumin, have not been implicated in the transmission of vCJD in the United States, the FDA is recommending the labeling changes after the discovery of such a case involving a woman in the United Kingdom. Despite finding the threat of transmission to be extremely low, particularly with products containing plasma-derived albumin, where the FDA notes that there is “no epidemiological evidence” to support the transmission of CJD or vCJD, the Agency ultimately decided upon these additional warnings to reflect the low-level risk associated with these products. The revised warning statements are as follows:

Plasma-derived products Other than Albumin

Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Plasma-derived Albumin

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin.

Products Containing Plasma-derived Albumin

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

Staying informed of current policies regarding the labeling of FDA-regulated products is important. FDA guidance documents are illustrative of the FDA’s current thinking on the particular topics they address, and while guidance documents technically do not carry the force of law, industry is largely expected to voluntarily comply with the recommendations set forth therein. For more information about FDA guidance documents or assistance with compliance, contact us at contact@sglawfl.com.

BSE, more commonly known as “mad-cow disease” is a deadly neurological disease in cattle that causes degeneration in the brain and spinal cord. The disease may be spread from diseased cattle to humans through the consumption of food contaminated by infected animals. Thus, it is critical that the federal government closely monitors the nation’s food supply to thwart the spread of this disease. According to the USDA, the recent BSE case is an isolated incident and involved an animal that never entered the food supply. Accordingly, the USDA notes that there is no threat for individuals consuming beef. More information about the BSE outbreak may be accessed here.

While the USDA oversees agricultural products, including cattle, to ensure that the nation’s food supply is safe for human consumption. In addition, the FDA is responsible for ensuring that those products not specifically covered by USDA regulations are safe for consumers, including other foods and dietary supplement products, many containing components of beef. Thus, the jurisdiction of the USDA and FDA has some overlap. While the current mad-cow case is within the primary responsibility of the USDA, the FDA’s statement highlights the cooperation between the federal agencies.