Recall & Adverse Event Programs for Supplements, NHPs & Foods

No supplement or functional food brand wants to think about recalls or adverse events. But regulators expect you to be prepared and retailers and distributors increasingly require it before they’ll carry your products.

Under 21 CFR 111 (supplements) and 21 CFR 117 (foods), the FDA requires brand owners to have written procedures for recalls and adverse event reporting. In Canada, Natural Health Product (NHP) license holders must comply with NNHPD adverse reaction reporting and Health Canada recall requirements. Without these programs, your brand risks fines, warning letters, delistings, and reputational damage.

At Blue Ocean Regulatory, we design and implement recall and adverse event programs tailored to supplement and food brands. We create audit-ready SOPs, train your team, and act as a fractional compliance resource so you can meet requirements and protect your business if the unexpected happens.

Why Recalls & Adverse Event Programs Matter

  • Regulatory compliance: FDA requires written recall procedures. Canada requires NHP site license holders to maintain adverse event and recall systems.

  • Retailer expectation: Amazon, Costco, Whole Foods, and distributors want proof you can execute a recall quickly if needed.

  • Consumer safety: A well-run recall minimizes consumer harm and protects your brand’s reputation.

  • Legal liability: Failure to report or mishandling an adverse event can lead to warning letters, lawsuits, or criminal liability.

The truth is, most brands are underprepared. They assume their manufacturer or distributor “handles it,” but regulators hold the brand owner accountable.

What Our Service Covers

We build systems that meet FDA, FTC, Health Canada, and CFIA expectations — and make sense for your business.

1. Recall Programs

  • Written recall SOPs compliant with FDA/Health Canada requirements.

  • Step-by-step procedures for identifying, classifying, and executing recalls.

  • Templates for FDA or Health Canada notification letters.

  • Mock recall drills to test readiness.

  • Guidance on consumer communications, press releases, and retailer notifications.

  • Integration with your Quality Management System (QMS).

2. Adverse Event Programs

  • SOPs for adverse event intake, investigation, and escalation.

  • Consumer-friendly intake forms and templates for call centers or customer service.

  • Review processes for determining “serious” vs. “non-serious” events.

  • Mandatory reporting procedures (FDA MedWatch for serious events, Health Canada for NHPs).

  • Recordkeeping systems aligned with regulatory retention requirements.

3. Training & Implementation

  • Staff training to recognize and report adverse events properly.

  • Simulated recall exercises to ensure team readiness.

  • Practical tools like intake logs, complaint forms, and escalation flowcharts.

Common Issues We Catch

Most supplement and food brands think they’re prepared - until they’re not. Common gaps include:

  • No written recall SOPs: Brands assume manufacturers will handle it, but FDA requires brand owners to have their own.

  • Ad hoc complaint handling: Customer service teams collect complaints without a system to flag adverse events.

  • Unclear escalation rules: Teams don’t know when to notify FDA or Health Canada.

  • No mock recalls: Brands have never tested whether their systems actually work.

  • Missing documentation: Inability to produce records during an FDA or Health Canada inspection.

  • Retailer surprises: Failing to meet retailer recall-readiness requirements during onboarding.

These gaps become critical under inspection — and can stop your brand from being retail-ready.

Our Approach

We make recall and adverse event systems practical and usable, not just paperwork:

  • Plain-language SOPs: Easy to follow for staff at every level.

  • Templates & tools: Pre-built forms and checklists you can use immediately.

  • Risk-based prioritization: Focus on the procedures most critical to your products and distribution model.

  • Fractional support: We can serve as your compliance partner, helping manage reporting and recall execution if needed.

Why Brands Work With Blue Ocean Regulatory

We understand how supplement and food brands operate — lean teams, outsourced manufacturing, rapid growth. Our programs are designed to fit your resources while meeting regulatory expectations.

Our expertise has been featured in NutraIngredients USA, we’ve been invited to guest speak at events hosted by the Council for Responsible Nutrition, and we’ve appeared on The Nutracast Podcast. Brands trust us because we combine deep regulatory knowledge with practical implementation.

Next Steps

If you don’t have written recall or adverse event programs — or if your documents haven’t been updated in the last year — you’re taking unnecessary risks. Retailers, investors, and regulators all expect you to be recall-ready.

Schedule a Recall & Adverse Event Program Review with Blue Ocean Regulatory today. We’ll build the SOPs, train your team, and give you the systems you need to stay compliant, retail-ready, and consumer-protected.