Update: On May 5, 2018, FDA finalized the extension to the labeling compliance dates via publication of a final rule.
On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to the nutrition facts label for packaged food and beverages sold in the United States. The extension would provide large food businesses (defined for these rules as grossing ten million dollars or more in annual sales) until January 1, 2020 to comply, while small businesses would have an additional year.
The rules, finalized in May 2016, do not solely consist of formatting changes, but also includes updates to serving sizes, daily values, and nutrient definitions. Despite the compliance deadlines appearing distant, the required changes are not superficial and may be time-consuming to implement. Registrar Corp urges food manufacturers to make proactive efforts now to update their product labeling and ensure compliance.
Why should I start making these changes now?
FDA proposed extending the deadlines due to covered parties’ concerns over complying in time with the initial deadline of July 2018. They cited “issues regarding (among other things) the need for upgrades to labeling software, the need to obtain nutrition information from suppliers, the number of products that would need new labels, and a limited time for reformulation of products.” (Source)
Also of potential concern are the mandated updates to daily values for certain nutrients, such as dietary fiber, which will require many food manufacturers to readjust certain percent daily values on their labels. In addition, manufacturers will need to account for the daily values of vitamin D and potassium, which will be newly required on a product’s food label.
Many manufacturers will need to conduct laboratory tests for vitamin D, potassium, and other nutrients in their products. As the deadlines approach, laboratories may see a high volume of food manufacturers requesting nutrient testing, leading to potential difficulties in scheduling tests as laboratories near capacity. The cost of tests may also increase from high demand, and delays in obtaining results may occur.
Additionally, the daily value updates affect the eligibility for some food manufacturers to make claims associated with the nutrients on their labels. Nutrient content claims that state products are “high in” these nutrients or health claims that state products containing these nutrients “may reduce the risk of” certain diseases require the product in question to contain a specific percentage of the nutrient’s daily value consumed in one serving. In order to continue making these claims, some manufacturers may need to reformulate a product to match the required content of a certain nutrient.
For example, the new rules increase the daily reference value (DRV) of fiber from 25 to 28 grams. FDA requires a product to contain 20% or more of the DRV per reference amount customarily consumed (RACC) in order to claim it is “high in fiber”. A product with 5 grams of fiber per 25-gram RACC (20%) may claim to be “high in fiber” now, but once the new DRV of 28 grams takes effect, it will only contain about 18%. The product may need to be reformulated with more fiber or the claim will need to be removed from the product labeling by the deadline.
Food labeling consists of several components. The earlier you begin, the more time you allot for the unexpected and improve the chance of avoiding a surplus of outdated labeling inventory. If you do not want to navigate the changes on your own, Registrar Corp’s Regulatory Specialists are well-versed in FDA’s new food labeling rules and can transition your product labels for you. In addition to a report explaining all our changes, you will receive a print-ready file of your revised label. For assistance, simply complete the form below or call us at +1-757-224-0177.
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