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FDA issues draft guidance on mandatory recall authority

The US Food and Drug Administration (FDA) has published draft guidance on mandatory food recall authority as part of the Food Safety Modernization Act of 2011 (FSMA).

The guidance gives the government authority to order a responsible party to recall food when FDA determines there is a reasonable probability that the food is adulterated or misbranded, and that the use of the food will cause serious adverse health consequences or death to humans or animals. Dietary supplements also are included under this guidance.

After the FDA decides a product should be recalled, it must give the company the opportunity to recall it voluntarily. If the company chooses not to conduct a voluntary recall, FDA can order it to stop selling the food and hold a hearing. After that, the FDA commissioner can order a recall.

Food is considered adulterated if it has any “poisonous or deleterious substance which may render it injurious to health; consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; or has been prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health.” Dietary supplements are adulterated when an ingredient presents a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling; or is a new ingredient that is not assured of safety; or poses an imminent hazard to public health or safety.”

Since 2011, FDA has used this power twice: a recall of Salmonella-contaminated pet treats in 2013, and the recall of OxyElite Pro Dietary Supplements in 2014.

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