2020 FDA Label Revisions: Are You Subject to the Final Rule?

As you very well know, the FDA released a final ruling on required label revisions for 2020. What you may not know is that just this past month, they released a “Small Entity Compliance Guide” that couples with the Guidance for the Industry for FDA label revisions. This guide stipulates all the granular details about application through compliance. If you are a food manufacturer who is curious as to whether your product falls under this final ruling, keep reading.

What Foods Are Subject to the Rule?

According to guide for FDA label revisions, your food product is subject to the rule IF:

  1. You manufacture foods that contribute to the general food supply. This means, if you make and sell food products that are consumed by people aged 4 year and up, this rule applies to your product.
  2. You manufacture foods for infants through children 3 years of age. With exception of infant formula, infant food included but not limited to snacks and pureed fruits, vegetables and other meal types all fall under the 2020 FDA label revisions.
  3. You manufacture foods specifically created for pregnant and lactating women. FDA label revisions apply to packaged food products that are marketed toward this particular group.
  4. You manufacture and sell dietary supplements. According to the FDA, all dietary supplements are still considered food and therefore subject to final rulings.

Which Foods are Exempt from the FDA Labeling Revisions?

  1. Food that is created by manufacturers and food businesses that don’t exceed annual gross sales of $500,000 are exempt from the FDA Labeling Revisions.
  2. Foods that are Medicinal in nature.
  3. Food that contains insignificant amounts of all nutrients (e.g., coffee beans, tea leaves).

Does your packaged food product fall under the final ruling for the new 2020 nutrition panel? If so, we are here to help! By choosing LabelCalc as your nutrition analysis and nutrition panel provider, FDA-compliance is automatically built into our entry process. Contact us for more information.

What is LabelCalc?

LabelCalcⓇ is one of FoodCalc LLC’s two nutrition analysis products, created to help meet the needs of the food industry. Based in San Francisco, CA, we are a nationally recognized provider of online nutrition analysis that is fast, accurate, and FDA-compliant.

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