An Adverse Event Can Create a Product Recall – By Global Clinicals Inc. CEO, Chris Baker
Every company that sells dietary supplements must be aware of the possibility of a product recall. The good news for consumers is that many product recalls are voluntary, typically generated by the company before any adverse event occurs.
Dietary supplements may be recalled for many reasons, including:
1.) The Food and Drug Administration (FDA) requires that a product is taken off store shelves due to an adverse-event recall (AER).
2.) A company may institute a recall of one of its products because it realizes that the product currently does not meet its label claims or it contains an ingredient or contaminant that may cause an adverse event.
Here’s more about each of these scenarios.
Why the FDA orders a product recall
Government agencies, companies that sell dietary supplements, and consumers all have the same goals in mind: To provide consumers with safe and effective products.
When a product is found to be mislabeled or potentially harmful, the FDA will likely order a product recall. These fall into three categories:
Class I: A recall of this type is for a product that has a reasonable likelihood of causing serious health consequences or death. The former category includes inpatient hospitalization, significant or persistent disability, or a congenital birth defect or anomaly, as per the FDA.
Class II: Products recalled under this category have a relatively small chance of causing serious health consequences, but may cause temporary or medically reversible adverse harm to health.
Class III: These recalls pertain to products that are not likely to cause adverse health consequences, but may require a company to address discrepancies between what the product contains and how it is labeled.
Why a company orders a product recall of its own product
When a company learns that one of its products may cause serious health problems or death, the company must report this information to the FDA within 24 hours. Companies that have done their due diligence, though, are aware that the problem does not reside with their formulation; the history of dietary supplement recalls demonstrates that the overwhelming majority of problems associated with AERs or those where a product contains agents not listed on the label are most likely due to a tainted ingredient.
This means that a product may contain an allergen, chemical, or excessive amount of a nutrient not disclosed on the label. In these cases, a company will often institute a recall of its own product.
How to handle a product recall
Regardless of whether the FDA orders a recall or a company institutes the recall itself, the company should strive to get ahead of the story. After filing the proper paperwork with the FDA (see link below), it’s almost always a good idea to issue a press release, explaining the facts as your company understands them to date. It’s also in a company’s interest to work with the FDA as necessary.
Here’s a boilerplate for how you can put together a statement address a recall for one of your company’s products.
1.) State your commitment to your customers. “Nothing is more important to [company name] than our customers’ health and well-being.”
2.) Briefly describe the impetus of the impetus for the recall. “Based on a request from the FDA, [company name] has issued a recall of [product name].”
3.) Give a terse reason for the recall. “It has come to our attention that [product name] contains [contaminant, allergen, etc.], and we do not want our customers to be exposed to this.”
4.) Give an explanation for how this happened (if this info is available). “While [company name] takes the greatest care in providing you with quality products, the recalled product contains [excess amounts of an allergen, contaminant], and we are [no longer working with/working to resolve this issue] with this distributor.” NOTE: The language depends upon your company’s future relationship with this distributor.
5.) Provide guidance toward resolution. “We are working diligently to resolve this issue.
6.) Apologize. “We sincerely apologize to each of our customers.”
After issuing a statement, of course, your company’s emphasis needs to be on rectifying the problem with the product. Once you have an understanding of how this crisis will be resolved, it is often a good idea to offer a second press release, letting your customers know your intent.
For more information on reporting safety information to the FDA, go to:
FDA Site: Dietary Supplements – Adverse Event Reporting:
Safety reporting portal: