Required front-of-pack (FOP) declarations on all prepackaged food and non-alcoholic beverages sold in Mexico could inspire Latin American or other countries to establish their own labeling regulations as well.

The Bureau’s first major update in decades affects labeling for distilled spirits, wine, beer, and hard seltzers. Surprisingly, it gives industry greater flexibility in certain areas, including loosening some COVID-19 restrictions.

Label language will be in the crosshairs for food and beverage packagers in the new year, with new and updated regulations increasing litigation risk in some instances. On-pack claims like “healthy,” “natural” and “no genetically modified...

The National Bioengineered Food Disclosure Law—signed into law on July 29, 2016—directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July...

Audits of quality systems are required in the medical device industry—but are you conducting your own internal audits on a routine basis? Are you including your packaging operations?Internal audits at planned intervals are expected under 21 CFR...

By Joan Sylvain Baughan and Cynthia Lieberman The U.S. FDA evaluates the safety and suitability of drug packaging as part of the premarket approval process for new drugs. The manner in which packaging suppliers have relayed information...

FDA has issued binding guidance that will require electronic filing of all Drug Master Files and DMF-related submissions as of May 5, 2017.

FDA has issued binding guidance that will require electronic filing of all Drug Master Files and DMF-related submissions as of May 5, 2017.

Labeling of genetically modified (GM) food products (so-called Franken foods, according to their critics) has been a hotly contentious issue for at least 20 years now. It has only been in the last few years, though, that momentum built at the...

Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically. As we explained earlier this year, DMF submissions and related documents will need to be filed electronically...