By Michael Shabaka, Ph.D., Manex Director of Sales and Innovation Excellence
On May 27, 2016, the U.S. Food and Drug Administration (FDA) published the final rule amending food label requirements.
The final rule amends the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices with a compliance date of July 26, 2018 for manufacturers with $10 million or more in annual food sales, and July 26, 2019 for manufacturers with less than $10 million in annual food sales.
The FDA recently extended these dates to January 2020 and January 2021 respectively. The FDA has created a Small Industry Compliance Guide to help companies better understand who needs to be compliant and how to become compliant. The FDA does not intend for the document to serve as legal advice and refers to this document as recommendations for compliance. Upon review of the 38-page document, it notes that all food, including supplements and infant foods must be compliant with the new labeling requirements, but there are some exceptions.
Under 21 Code of Federal Regulations (CFR) 101.9(j), product exceptions to the new label requirements generally include:
- foods offered for sale by a retailer who has annual gross sales made or business done in sales to consumers that is not more than $500,000;
- foods offered for sale by a retailer who has annual gross sales made or business done in sales of food to consumers of not more than $50,000;
- medical foods; and
- foods that contain insignificant amounts of all nutrients (e.g., coffee beans, tea leaves).
If your small business does not manufacture foods that fall within these four exceptions, then you must be fully compliant with the new rules by January 2021.Compliance with the new labeling requirements can be confusing. For example, section V titled: “Which Nutrients Must Newly be Declared, and What Changes Have Been Made to Nutrients Previously Required or Allowed to be Declared?” provides an example of how to address added sugars and what is considered added sugar.
The guideline states that added sugars are defined as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type, (21 CFR 101.9(c)(6)(iii)). This definition includes single-ingredient foods, such as individually packaged table sugar (see Section V.A.1.(a).(i) and Ref. 1). But there appears to be another twist that can make the new rules confusing and why I believe the FDA is giving smaller manufacturers more time to comply.
For example, the following do not fall under the definition of added sugars. Sugars in fruit or vegetable juice concentrated from 100 percent juices that are sold to consumers (e.g., frozen 100 percent fruit juice concentrate) (21 CFR 101.9(c)(6)(iii)). Sugars in fruit juice concentrates that are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standards of identities set forth in 21 CFR 150.140 and 150.160 (21 CFR 101.9(c)(6)(iii)). Sugars in the fruit component of fruit spreads (21 CFR 101.9(c)(6)(iii)). Sugar alcohols and Sugars in juice concentrates that are counted towards percentage juice label declaration under 21 CFR 101.30 for 100 percent juice or 21 CFR 102.33 for juice beverages (21 CFR 101.9(c)(6)(iii)). Sugars in juice concentrates that are used to standardize the Brix values of a single species juice consisting of juice directly expressed from a fruit or vegetable in accordance with 21 CFR 102.33(g)(2) (21 CFR 101.9(c)(6)(iii)). Naturally-occurring sugars found in milk and dairy ingredients, except lactose as defined in 21 CFR 168.122.
The food labeling laws can be a daunting task, especially if there are product changes or reformulations. The additional year that the FDA has provided to ensure manufacturers are compliant can help businesses become fully compliant with the new food label requirements. Does your business understand the new label rules, and will your business be fully compliant with the new food label requirements on January 1, 2021?
About the Author
Michael Shabaka, Ph.D., is the Director of Sales and Innovation Excellence for Manex. He has over 20 years of business development, sales and marketing experience, spanning several industries including biotech, high tech, publishing, environmental lab services, and the non-profit sector. Dr. Shabaka holds a Ph.D. in Organizational Behavior with a concentration in Transformative Learning and Change from the California Institute of Integral Studies, San Francisco. He also holds a Master of Business Administration degree in Marketing and Finance and a Bachelor of Arts degree in International Affairs from Holy Names College, Oakland. He can be reached at firstname.lastname@example.org.