Issue link: https://www.e-digitaleditions.com/i/1295512
32D October 2020 Tablets & Capsules embracing changes to the Supplement Facts panel and other labeling is now. The efforts companies make now to carefully examine, or have knowledgeable partners examine, all product packaging and labeling to ensure compliance with the federal labeling regulation revisions could go a long way toward avoiding unnecessary costs down the road. T&C References 1. www.govinfo.gov/content/pkg/FR-2016-05-27/pdf/ 2016-11867.pdf 2. www.fda.gov/media/97999/download 3. www.law.cornell.edu/cfr/text/21/101.9 4. www.law.cornell.edu/cfr/text/21/101.13 5. www.law.cornell.edu/cfr/text/21/101.54 Justin J. Prochnow is an attorney and shareholder of Greenberg Traurig LLP, an international law firm (303 572 6562, proch nowjj@gtlaw.com). His practice concentrates on legal issues affecting the food and beverage, dietary supplement, and cosmetic industries. He can be followed on Twitter at @LawguyJP. This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively. Accepting change and moving forward In the grand scheme of things, is it really a big deal if companies don't realize right away that the changes to the labeling regulations might also impact the ability to make certain claims? Of course, companies should always comply with the laws and regulations, but typi- cally the FDA will grant some additional lag time before aggressively enforcing new regulations. However, we have another group of actors waiting for the revisions to the labeling regulations to become fully mandatory for all companies, so they can pursue legal action against non-compliant companies. Class action plaintiff lawyers love to bring actions over technical labeling require- ments such as nutrient content claims. You can bet that these lawyers will have their calculators out and ready to check the math and make sure that nutrient content claims have been made based on the new RDIs and DRVs. Those nutraceutical companies that have not revised their claims accordingly should not be surprised when they receive a "Dear CEO" letter in the mail, threatening a class action lawsuit unless the manufacturer makes appropriate changes and compensates the alleged aggrieved plaintiffs or, more accurately, the alleged aggrieved plaintiffs' lawyers. By January 1, 2021, all new labeling must be compliant with the revised provisions of 21 CFR 101.9 and 21 CFR 101.36. For dietary supplement companies, the time for Customized Fill Release in Gelatine Soft Capsules Revolutionary Release Fast release and reduced cross-linking Reliable Release Reduced cross-linking Standard Release Improved shelf-life and stability Release profile Enteric Release One-step-production of truly enteric capsules GELITA USA · Sioux City, IA · www.gelita.com · service.na@gelita.com