Three Regulatory Updates to Know, Now

Breaking: FDA names January 1, 2020, as revised compliance date for new Nutrition Facts Label in proposed rule.

The FDA’s proposed rule confirms industry speculation and provides a revised framework for planning compliance by 2020.

Are you prepared for the upcoming deadline?

Our Labeling Checklist is easy:

• Call on NK to ensure new calculations are applied correctly in the new label format, and to make the most of allowable claims and other marketing opportunities.

Use this Regulatory Checklist to avoid common mistakes when creating revised product specifications:

• New mandatory nutrients calculated correctly – Added Sugars, Vitamin D, Potassium
• New actual nutrient amounts calculated correctly – Vitamin D, Calcium, Iron, Potassium
• Serving sizes based on new Reference Amounts
• % DVs calculated using new RDIs or DRVs
• Dual column Nutrition Facts format used for packages that could reasonably be consumed in one sitting
• Dietary fiber meets new guidelines

Note that manufacturers with annual food sales under $10 million will still have an additional year to comply (January 1, 2021).

Revised USDA Label Approval Guidelines

While the final Nutrition Facts panel regulations for USDA products are still undefined, sitting on the inactive list, the USDA has released revised guidance on label approvals.

The key watch-out: Be aware that any special statement or claim will trigger a review, aka higher scrutiny, from the Labeling and Program Delivery Staff (LPDS).

Knock any claim out of the running if it doesn’t pass a quick “approvability” test:

• Truthful
• Transparent
• Proven

“Natural”, “non-GMO”, and “humanely raised” are especially hot claims right now – awaiting further definition from regulatory bodies. In the meantime, LPDS will review all label claims carefully, so be prepared.

When making hot-topic claims, be sure to factor in the appropriate USDA approval time, know your facts and get your proof in order.

Key Points:

LPDS only needs to evaluate four types of labels (9 CFR 412.1 (c)):
1) Labels for religious exempt products (9 CFR 412.1 (c) (1).
2) Labels for export with deviations from domestic requirements (9 CFR 412.1 (c) (2).
3) Labels with special statements and claims (9 CFR 412.1 (c) (3). [see excerpt below]
4) Labels for temporary approval (9 CFR 412.1 (c) (4)

See revised “Special statements and claims” definition below:

(e) “Special statements and claims” are claims, logos, trademarks, and other symbols on labels that are not defined in the Federal meat and poultry products inspection regulations or the Food Standards and Labeling Policy Book, (except for “natural” and negative claims (e.g., “gluten free”)), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims regarding the raising of animals, organic claims, and instructional or disclaimer statements concerning pathogens (e.g., “for cooking only” or “not tested for E. coli O157:H7”). Examples of logos and symbols include graphic representations of hearts and geographic landmarks. Special statements and claims do not include allergen statements (e.g., “contains soy”) applied in accordance with the Food Allergen Labeling and Consumer Protection Act.

Peanuts: New Qualified Health Claim Announced

Good news for peanut-containing products, especially those marketed to parents: There’s a new approved health claim in the labeling toolkit.

“This is the first time the FDA has recognized a qualified health claim to prevent a food allergy,” says FDA Commissioner Scott Gottlieb, M.D., in a recent statement.

The full claim is as follows:

“For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age.”