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FDA Food Safety News

FDA Updates Food Labeling Compliance Program

FDA food labeling compliance program update 2025

The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements more effectively. On June 24, 2025, the U.S. Food and Drug Administration (FDA) announced a revised Compliance Program Manual (CPM) for general food labeling.

This update is part of the agency’s broader efforts to modernize food safety oversight and streamline inspections. If your business manufactures, processes, or imports packaged foods into the U.S., this change matters. Keep reading to learn what’s new and how to prepare.

What changed in the FDA labeling compliance manual?

The updated Compliance Program 7321.005 includes revised instructions for FDA investigators during routine inspections. While the foundational labeling regulations remain the same, the update improves how inspections are conducted.

It also introduces key content updates. For example, sesame is now recognized as the ninth major food allergen under the FASTER Act of 2021. Moreover, the program includes guidance on gluten-free claims and reflects the 2016 Nutrition Facts label updates, such as formatting and nutrient declaration changes. Together, these changes align compliance efforts with current laws and consumer needs.

According to the FDA’s official announcement, the revised manual aims to improve consistency across FDA field offices by streamlining inspection procedures and reinforcing how labeling regulations are interpreted and applied.

This update doesn’t add new rules. However, it indicates that inspections will become more structured and focused.

What does it mean for your business?

You might worry that a compliance program update means more paperwork or stricter rules. Fortunately, that’s not the case here. The core food labeling requirements under the Food, Drug, and Cosmetic Act (FDCA) and Fair Packaging and Labeling Act (FPLA) remain the same.

Still, your business should pay close attention. FDA investigators will now be guided by updated inspection procedures. This includes a focus on:

  • Proper display of net quantity of contents
  • Accurate ingredient and allergen declarations
  • Appropriate use of nutrient content claims and health claims

So, even though the regulations didn’t change, the way they’re enforced is evolving. That’s why it’s a good time to reassess your current food labels to ensure full compliance.

Do Canadian and international companies need to act?

Yes, especially if you export packaged food to the U.S. The FDA does not exempt foreign manufacturers from inspection or enforcement. Without proper labeling, your products may experience delays, detentions, or outright refusal at the border.

Fortunately, you can stay ahead of these changes with the right regulatory support.

How to stay compliant with evolving FDA labeling standards

Food labeling compliance can be complex, especially with different requirements across countries. That’s why working with experienced professionals is essential.

At Quality Smart Solutions, we help Canadian, U.S., and international businesses navigate FDA food labeling regulations with confidence. Our services include:

  • FDA-compliant label review and formatting
  • Nutrition facts table development (U.S. and bilingual formats)
  • Ingredient and allergen verification
  • Claims compliance for nutrient content and health statements

Need help reviewing your product labels? Contact our team to get started. You can also explore our FDA food compliance solutions and let our experts guide you every step of the way.

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Health Canada Natural Health Products (NHPs)

Class II NHP submissions: What Health Canada’s new workload rules mean for you

Health Canada Class II NHP workload management criteria and submission rules

Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed them. Health Canada is updating how it handles licensing applications by applying a new workload management approach, prioritizing submissions based on intent to sell or manufacture in Canada.

If your product doesn’t meet these criteria, or you forget to submit the right form, your application might be delayed. In this blog, we explain what the new approach means, how it affects your licensing strategy, and what steps you need to take to stay on track.

What are Class II NHPs?

Class II natural health products (NHPs) fall in the middle of Health Canada’s risk-based classification system. These products usually include ingredients with strong evidence of safety and efficacy but require more documentation than Class I products.

Unlike Class I submissions, which rely only on pre-cleared information, Class II submissions may combine monograph and non-monograph ingredients. This means applicants need to provide additional data to support their claims, though review times are typically faster than for Class III submissions.

Why Health Canada is changing how it handles Class II NHPs

Until now, Class II NHP submissions were managed on a first-come, first-served basis. But with growing submission volumes and limited resources, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is shifting its review strategy.

From June 9 onward, only applications that show a clear intent to sell or manufacture in Canada within six months will be prioritized for review. This aligns with how Class III submissions are already being handled. For you, this means extra steps, but also more predictability if you follow them correctly.

What you need to do to stay compliant

To benefit from prioritized review, you’ll need to follow a few extra steps under Health Canada’s updated system. It’s no longer just about submitting your application and waiting your turn. Now, Health Canada is prioritizing submissions that show a clear plan to enter the Canadian market soon.

If you plan to sell or manufacture your product within six months of licensing, and you submit the correct form on time, you’ll move ahead in the queue. If not, your submission could be delayed. Here’s what you’ll need to do to stay on track:

  • Confirm that your product will be sold or manufactured in Canada within six months of licensing
  • Submit a Workload Management Form within seven days of receiving your acknowledgment letter from NNHPD
  • Provide accurate information, including your submission number, brand name, and authorized signing official

The form you choose will depend on whether the product is being sold or only manufactured in Canada. And yes, Health Canada will deprioritize your file if you skip this step or fill it out incorrectly.

Supporting your Class II NHP submissions

Navigating licensing is already a time-consuming process. With these new changes, staying compliant is about more than just submitting the right paperwork, it’s about knowing when and how to act.

At Quality Smart Solutions, we help guide you through every stage of the NHP licensing process. We prepare your product licence application, assist with your Workload Management Form, and make sure your submission is complete, accurate, and aligned with the new criteria.

We act as your regulatory partner, so you don’t have to worry about missed deadlines or deprioritized submissions.

Key tips for staying on track with Health Canada’s new process

Here’s what to keep in mind when submitting your Class II NHP application:

  1. Choose the right form:
    1. Form 1: Products Sold in Canada – For products intended for sale (and possibly manufacturing) or
    2. Form 2: Manufactured in Canada – For products only being manufactured, not sold
  2. Submit within 7 days: Once you receive your acknowledgment letter and submission number, you have 7 calendar days to submit your form
  3. Verify your info: Double-check your company name, brand name, file/submission number, and signing official
  4. Monitor your submission status: If your form isn’t submitted or is filled out incorrectly, your submission will be reviewed later, when resources allow
  5. Include accurate site info: You must comply with section 22 of the NHPR by providing valid site details before your product goes to market

For additional information, you can check the full bulletin directly from Health Canada.

Frequently asked questions

Will my Class II submission be delayed if I don’t submit the form?

Yes. Without the Workload Management Form, your application will be deprioritized and only reviewed when capacity allows.

It’s better to wait. You can withdraw and resubmit when your product is closer to entering the market.

Good news, applications submitted before this date don’t need a Workload Management Form and will be processed under the previous system.

You can use the ‘Products Sold in Canada’ form and include both sets of information in your submission.

Ready to get licensed? Let us help

Health Canada’s updated process for Class II NHP submissions puts more pressure on applicants to meet the right requirements within a narrow timeframe. But you don’t have to manage this alone.

Our experts at Quality Smart Solutions are here to guide you through it all, from forms to filings and final approvals. Get in touch with us today or learn more about our Natural Health Product licensing and consulting services. Let’s make your path to compliance easier.

Categories
Blog FDA Compliance

FY 2025 OMUFA Fees Due June 2: What You Need to Know

FDA OMUFA FY 2025 fee deadline for OTC manufacturers

The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a manufacturer or contract manufacturer of over-the-counter (OTC) monograph drug products at any time in 2024, you’ll need to pay this annual fee.

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is modeled after the Prescription Drug User Fee Act (PDUFA). Under OMUFA, fees paid by industry help fund the FDA’s oversight of OTC monograph drugs. In return, the FDA commits to performance goals that include timelines for reviewing and updating OTC monograph activities.

OTC monograph drug facility fees for FY 2025 are due on Monday, June 2, 2025. If you miss the fee deadline, your facility could be placed on a public arrears list, and any OTC monograph drugs made there could be classified as misbranded.

Who this applies to and what’s required

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) applies to manufacturers and contract manufacturers of OTC monograph drug products.

Under OMUFA, the FDA collects two types of user fees: facility fees and OTC Monograph Order Request (OMOR) fees. Facility fees are due annually, while OMOR fees are due at the time of submission. For FY 2025, the facility fee must be paid by Monday, June 2, 2025.

From fiscal years 2021 through 2025, facility fees are due on the later of either the first business day of June each year or the first business day after Congress passes an appropriations act allowing the FDA to collect OMUFA fees.

If your company qualifies, you have 20 calendar days from the official announcement (June 2, 2025) to pay. That puts your final deadline at June 22, 2025.

Missing this deadline means your company could appear on the FDA’s arrears list, your products could be labeled as misbranded, and your business may face regulatory or distribution delays.

How much is the FY 2025 FDA user fee?

The FDA has released the official FY 2025 OMUFA user fees: 

  • Monograph Drug Facility (MDF) Fee: $37,556 USD 
  • Contract Manufacturing Organization (CMO) Fee: $25,037 USD 

You can review the complete list, including OMOR Tier 1 and Tier 2 fees, on the FDA’s OMUFA user fee page. 

What to do before June 2

To avoid penalties and stay in good standing with the FDA, make sure to: 

  • Check your registration status: Was your facility registered with the FDA as an OTC drug manufacturer or contract manufacturer in 2024? 
  • Confirm your classification: Determine whether you’re subject to the MDF or CMO fee based on your facility’s role. 
  • Prepare and submit payment: Ensure the correct fee is paid before the June 22, 2025 deadline. 

Taking action now helps prevent misbranding issues, delays in product distribution, and placement on the FDA’s arrears list. 

Frequently asked questions

I received a fee notice, but I don’t think my facility should be charged an OMUFA facility fee for FY 2025. What should I do?

If you believe your facility is not an OTC monograph drug facility as described in this notice and should not be assessed an OMUFA FY 2025 facility fee, please contact CDERCollections@fda.hhs.gov.

No. All companies pay the same applicable fee (i.e., facility and/or OMOR), regardless of size.

No. It’s your responsibility to track your registration status and meet the payment deadline.

Your facility may be listed publicly in arrears, and your OTC products could be misbranded. This can delay sales and trigger compliance actions.

We can help you assess your situation. Reach out and we’ll review your registration and business model to confirm.

Don’t risk being out of compliance 

The OMUFA FY 2025 fee deadline is right around the corner. If you’re registered as a facility that makes or supports OTC monograph drugs, make sure to submit your payment by June 2, 2025. 

Need support? Connect with our regulatory experts today and let us help you stay compliant. 

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Natural Products Expo West 2025

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Schedule a Meeting

Expo West is a fast-paced event, and we want to ensure you receive the expert advice and guidance needed to succeed. Our regulatory specialists will be available for in-person discussions throughout the event to answer your questions and explore how we can help your products thrive in today’s competitive landscape. Book a meeting with our team today and take the next step toward regulatory success.

Quality Smart Solutions at Natural Products Expo West 2024

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