Tag: food safety modernization act

FDA Finalizes FSVP Guidance for Importers of Human and Animal Food

On January 10, the FDA issued a final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. As our readers know, under the Food Safety Modernization Act (FSMA), FSVP requires that importers verify that the food which they import provides the same level of public health protection as the preventive controls or produce safety regulations (as appropriate) in the U.S. and to ensure that supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

The guidance is intended to assist importers in developing and implementing FSVP records, and following FSVP requirements for each food they import. The guidance includes recommendations on the requirements to analyze the hazards in food; how to evaluate a potential foreign supplier’s performance and the risk posed by the food; ways to determine and conduct appropriate foreign supplier verification activities; and how importers of dietary supplements or very small importers can meet modified FSVP requirements.

The guidance finalizes a 2018 draft guidance, and addresses comments received regarding what food the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform the FSVP activities.

For more Biotech, Food, and Drug Legal News, click here to visit the National Law Review.

© 2023 Keller and Heckman LLP

FDA Issues Draft Guidance on Mandatory Food Recalls Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) recently issued a draft guidance titled, “Questions and Answers Regarding Mandatory Food Recalls.” FDA was given general mandatory food recall authority by the Food Safety Modernization Act (FSMA). The guidance is notable for its brevity, coming in at a total of seven pages including the cover. Although much of the content will be familiar to those with experience in food recalls, the guidance does discuss the procedure for FDA to order a mandatory food recall and the assessment of user fees for those subject to such a recall.

With respect to the procedure, the guidance states after FDA finds that the criteria for a mandatory recall have been met, it must first provide the responsible party with an opportunity to perform a voluntary recall of the food. FDA will provide this opportunity in writing using an expeditious method. If the responsible party does not voluntarily cease distribution and recall the food within the time and manner prescribed by FDA, FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity for an informal hearing. After these steps are completed, FDA may order a recall if it determines that the removal of the food from commerce is necessary. Only the FDA Commissioner has the authority to order a recall.

As to user fees, the guidance observes that the FDA has the authority to collect fees from a responsible party for a domestic facility and an importer who does not comply with a food recall order. The fees would cover time spent by FDA conducting food recall activities, including technical assistance, follow-up effectiveness checks, and public notifications. FDA defines noncompliance to include (1) not initiating a recall as ordered by FDA, (2) not conducting the recall in the manner specified by FDA in the recall order, or (3) not providing FDA with requested information regarding the recall, as ordered by FDA. FDA publishes a Federal Register notice of fees for non-compliance with a Recall Order no later than 60 days before the start of each fiscal year.

Given that most parties will voluntarily recall food when the statutory conditions are satisfied to avoid a public relations disaster and harsh FDA action, it seems unlikely that FDA will have to resort often to the exercise of its mandatory recall authority or assessment of fees. The fact that FDA has this authority, however, helps ensure FDA will not have to exercise it.

A copy of the draft guidance document can be found here.

ARTICLE BY Hae Park-Suk & Lynn C. Tyler, M.S. of Barnes & Thornburg LLP
© 2015 BARNES & THORNBURG LLP

FDA Discloses Method for Classifying Food Facilities as "High Risk" Under FSMA

The National Law Review published an article regarding FDA High Risk Food Facilities Classification Methods written by Lynn C. Tyler, M.S., Nicolette R. Hudson and Hae Park-Suk of Barnes & Thornburg LLP:

The Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, requires FDA to inspect food facilities on different time tables depending on whether a facility is classified as “high risk” or not. High-risk facilities must be inspected at least once within the first five years after the enactment of the FSMA and once every three years thereafter. Non-high risk facilities must be inspected at least once within the first seven years after the enactment of the FSMA and once every five years thereafter.

The U.S. Food and Drug Administration (FDA) recently disclosed the method it intends to follow to classify food facilities as high risk or non-high risk under the FSMA. The agency first noted that the FSMA set forth six risk factors to be considered in making this determination:

  • The known safety risks of the food manufactured, processed, packed or held at the facility
  • The compliance history of the facility
  • The facility’s hazard analysis and risk-based preventive controls (HARBPC)
  • Whether the food at the facility meets the criteria for priority to detect intentional adulteration in imported food
  • Whether the food at the facility has received certain certifications
  • Other criteria identified by Health and Human Services

FDA then noted that for FY 2011-13 the classification decision will be based primarily on the first two factors and according to the following algorithms:

  • If a facility manufactures food categories associated with foodborne outbreaks AND class I recalls (reasonable probability of serious adverse health consequences or death), it is high risk
  • If a facility manufactures food categories associated with foodborne outbreaks OR class I recalls AND it has not been inspected within the last five years, it is high risk
  • Facilities with a checkered compliance history (three or more inspections resulting in Voluntary Action Indicated findings or one or more resulting in Official Action Indicated findings within the last five years) are high risk

FDA stated that it plans to modify and adjust these criteria in the future as it develops data on some of the FSMA criteria and for other reasons. It also reserved the right to inspect a facility more frequently when necessary in its judgment.

© 2012 BARNES & THORNBURG LLP