'Mock' Recalls Suggested, But US FDA Isn't Joking About Recalling Products

FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms. Instead, on top of November guidance on mandatory recall authority and February guidance on recall public notifications, FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.

Any doubts about the US Food and Drug Administration's expectations for regulated industries' compliance with its recall regulations should end as it publishes its third guidance in six months on firms' responsibilities for removing noncompliant products from the market.

The agency's voluntary recalls draft guidance includes training among it suggestions – not only training employees but also training a company through "mock recalls."

In an April 23 announcement, Associate Commissioner for Regulatory Affairs Melinda Plaisier said the agency's draft guidance on voluntary recall following final guidances on recall public notifications and on the FDA's mandatory recall authority for food and dietary supplement products "have made important improvements toward our goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products."

The voluntary recalls draft guidance isn't the last step. "But we know there is more that needs to be done. Moving forward, the agency will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts," Plaisier said.

"For companies that have not had recent experience with recall situations, being 'prepared' is not the same as being ready to make the necessary judgments and act accordingly." – Peter Mathers, Kleinfeld, Kaplan and Becker partner

The FDA's suggestions in the draft guidance largely track with advice food and drug attorneys long have offered to consumer health product firms. With that history, the suggestions shouldn't be surprises to firms in the OTC drug and vitamin, mineral and supplement product industries.

“We’re glad to see FDA stating what they and industry already recognize as ‘best practice’ so that anyone needing to conduct a voluntary recall will have clear guidance to help them accomplish it the right way,” said Barbara Kochanowski, the Consumer Healthcare Product Association's regulatory and scientific affairs executive.

Instead, with the voluntary recalls draft guidance prepared for publication in the April 24 Federal Register following the November 2018 guidance on the its mandatory recall authority and the February guidance on recall public notifications (see sidebars below), the FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.

"The advice FDA is providing about being prepared proactively for recall situations is indeed advice we have provided industry for decades. But, for companies that have not had recent experience with recall situations, being 'prepared' is not the same as being ready to make the necessary judgments and act accordingly," said Peter Mathers, a partner at Kleinfeld, Kaplan and Becker LLP in Washington.

Guidance Needed As FDA Attention Rises

In addition to the recall guidances, FDA in October published a draft guidance on identifying points-of-sale for recalled food products. The agency says it will publish addresses for retailers offering supplements and other food products recalled due to "a reasonable probability" using the product "will cause serious adverse health consequences or death." (Also see "Recalls With Potential For Serious Health Risks Will Identify Points Of Sale" - HBW Insight, 8 Oct, 2018.)

The voluntary recalls draft guidance comes a year after the FDA for the first time exercised its mandatory recall authority over food and supplement products to order Triangle Pharmanaturals LLC to recall all the kratom-containing products it distributed and to cease distributing additional products. The order followed two requests the agency made to the Las Vegas firm to voluntarily recall the products. (Also see "Las Vegas Kratom Marketer Rolls Dice On FDA's Mandatory Recall Authority" - HBW Insight, 3 Apr, 2018.)

More recently, the FDA in March announced it confirmed reports tracing to late 2017 that cosmetics in Claire’s Stores Inc. stores were contaminated with asbestos after the firm refused a request to recall the products. Claire's Stores voluntarily recalled nearly 50,000 makeup products a week after the agency's announcement. (Also see "Nearly 50,000 Claire's Packages Recalled; More ED Drugs In Supplements" - HBW Insight, 12 Apr, 2019.)

Given the FDA's heightened attention to recalls, the voluntary recalls draft guidance is needed, Mathers said in an email.

"Also, although FDA appears recently to be a bit more responsive to notifications of potential recall situations, companies are still quite often left to make decisions without meaningful FDA feedback, potentially at significant risk of being second-guessed by the agency later," he said.

"That can be a cause for caution and delay, particularly for firms that are often faced with limited information and uncertainty about recalls – particularly about the depth of a recall that is appropriate or that FDA will ultimately say was required. So, it is often just as important for FDA to be proactive in engaging with companies faced with recall decisions as it is for the companies to have procedures in place for implementing those decisions when needed."

'Verify Recall Readiness'

The voluntary recalls draft guidance by the Office of Regulatory Affairs' Office of Strategic Planning and Operational Policy explains firms' responsibilities for recalls of products determined to be noncompliant with FDA regulations and states advice on being prepared to respond as well as on conducting recalls.

Training should be conducted beyond employees and perhaps contractors. "A firm that anticipates complex recalls may want to consider additional preparatory steps, such as mock recalls, to verify the firm’s recall readiness," the draft guidance states.

Mock recalls familiarize employees with processes and could improve the effectiveness of a firm’s recall program. The effectiveness of a mock recall could be measured by metrics a firm should establish. The agency advises "corrective action (such as modifications to procedures or additional training for employees) if [a firm] is not satisfied with the results of a mock or actual recall."

Another component of preparation, the draft guidance suggests, is a recall communications plan. A firm's plan should address not only internal communications and with the FDA but also to distributors, retailers or other "direct accounts" and to the public in the event a recall is necessary.

Recall notifications to direct accounts should include instructions for the method for responding to the notification and points-of-contact for follow-up communication, via telephone or e-mail, at the recalling firm. Direct accounts also should be given clear instructions regarding appropriate disposition of recalled products and ensure a product will not remain a risk to the public, the draft guidance states.

General And Specific Suggestions

For general preparations, the FDA also suggests identifying and training appropriate personnel for recall responsibilities; identifying reporting requirements associated with a firm's products; using adequate product to make possible positive lot identification; and maintaining distribution records to identify the locations of products recalled.

Under "Specific Recall Initiation Procedures," the FDA recommends preparing and maintaining written recall initiation procedures. A written guide will "help to minimize delays created by uncertainty as to the appropriate actions to take when a decision is made to initiate a recall, help ensure that necessary actions are not overlooked, and may minimize the disruptive effect a recall can have on a firm’s business,' the draft guidance states.

A firm’s written recall initiation procedures should assign responsibility and describe steps to perform all actions for initiating a recall, including ceasing distribution, shipment, and/or sales of products; developing a recall strategy considering factors such as potential risk to those exposed to a product and ease in identifying it; and notifying direct accounts.