If the label does not include the required domestic address or phone number through which the responsible person (manufacturer, packer, distributor, or retailer identified on the label) may receive a report of a serious adverse event associated with the use of the product, then it is misbranded.
Use U.S. Toll-Free Number for Reporting Serious Adverse Events. Don’t Risk Misbranding.
Why aren’t more people talking about how a missing phone number on dietary supplements and over-the-counter (OTC) drugs labels could get a company in serious trouble?
In the interest of consumer safety and public health, the U.S. Food and Drug Administration (FDA) has implemented specific labeling requirements for dietary supplements and over-the-counter (OTC) drugs.
One such requirement is the inclusion of a U.S. toll-free telephone number on the product label through which the responsible person, the manufacturer, packer, distributor, or retailer listed on the product, may receive reports of serious adverse events (SAEs) associated with the use of the product. This regulation ensures accountability and enables effective post-market surveillance. Here’s what you need to know before your next product hits the shelves.
If you’re selling dietary supplements or over-the-counter drugs in the U.S., your product label must include a domestic address or toll-free phone number for serious adverse event reports.
According to the FDA, a “serious adverse event” includes any health-related incident that results in:
● Death
● A life-threatening experience
● Inpatient hospitalization
● Persistent or significant disability
● Congenital anomaly or birth defect
● Medical or surgical intervention to prevent one of the above outcomes.
The responsible person, defined as the entity whose name appears on the product label, must provide a domestic toll-free number where consumers can report serious adverse events (SAEs). This applies whether the entity is the manufacturer, packer, distributor, or even a private-label retailer.
This isn’t just a suggestion. If your label is missing this info, the product is officially misbranded. That could mean recalls, regulatory action, or even fines.
The requirement applies to whoever’s named on the label, the manufacturer, packer, distributor, or retailer. The bottom line? Double-check your labels for a U.S. toll-free number or address before your product goes anywhere near the market. Protect your business, your customers, and your reputation, don’t skip this compliance step!
A product may be detained because it appears to be misbranded, meaning the labels contain false, misleading or missing a required information.
Per diem charges are applicable when cargo or containers are held beyond the applicable free time: $20.00 + $.04 per lb. per day. While the container or cargo is on hold, numerous fees will begin to pile up, such as row fees, demurrage fees (per day), shifting fees, and admin fees.
If you are unable to overcome the appearance of a violation, your product will be refused admission. You can then work with U.S. Customs and Border Protection (CBP) and FDA, to destroy the product or export it from the U.S. within 90 days of the refusal.
