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Compliance Labeling Final Rules

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Hinch Newman LLP

How to Avoid Scrutiny When Advertising or Labeling Made in USA

Hinch Newman LLP on

In 1997, following consumer research and public comments, the FTC published an Enforcement Policy Statement on U.S. Origin Claims to guide marketers and manufacturers that want to make an unqualified Made in USA claim under...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

ArentFox Schiff

Prop 65 Roundup - January 2025

ArentFox Schiff on

What Food Product Companies Need to Know About the New Proposition 65 Warning Requirements - On December 6, 2024, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements Proposition...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Davis Wright Tremaine LLP

FDA Extends Menu Labeling Compliance Date

On July 9, 2015, the U.S. Food and Drug Administration (FDA) announced that it is extending the date for compliance with its menu labeling requirements by one year. Under the new timeframe, businesses covered by the menu...more

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