U.S. Food and Drug Administration (FDA) Archives - Page 6 of 42

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States.

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.

New MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety substantiation
Compliance with Good Manufacturing Practices (GMPs)
Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.

Facility Registration and Product Listing

Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.

The FDA may suspend a facility’s registration if the FDA determines […]

By Jennifer Diaz|2024-02-02T14:08:08-05:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|2 Comments

FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA officially began enforcement on January 1, 2023 but gave a 60-day grace period before beginning to verify numbers.

What is a DUNS Number?

DUNS stands for Data Universal Numbering System. It is a proprietary system developed by Dun & Bradstreet (D&B) that assigns a unique number to a business entity that is recognized worldwide. The DUNS system is not unique to the FDA. Other DUNS users include the UN, Apple, and the European Commission.

Why is the FDA Requiring This Now?

The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. The DUNS requirement dates back to 2016 when the agency issued a rule implementing new food facility registration requirements. Under the rule, the FDA requires facilities to provide a unique facility identifier (UFI) when registering. Subsequent guidance provided that a DUNS number is an acceptable UFI for registration.

The utilization of DUNS numbers will help the FDA:

Improve accuracy and consistency in the registration database
Identify facilities that pose a risk
Verify the authenticity of registrations
Ensure that facility information is up to date

The FDA has been working with facilities who have had difficulty obtaining a DUNS number and has issued guidance allowing registrants to enter a “PENDING” status if they cannot obtain a number in time.

What Do Food Facilities Need to Do?

Food facilities that […]

By Jennifer Diaz|2023-04-27T21:58:55-04:00April 27, 2023|U.S. Food and Drug Administration (FDA)|0 Comments

USDA Proposes New “Made in the USA” Standard

U.S. consumers who seek animal food products labeled as “Made in the USA,” or who simply value transparency on food product labels, may finally catch a break. On March 6, 2023, the USDA released a proposed rule to help define what is meant when a food product is a “Product of USA” or “Made in the USA.” Currently, Food Safety and Inspection Service (FSIS) regulated products may be labeled as “Product of USA” even when an animal product is derived “from animals that may have been born, raised, and slaughtered in another country but are minimally processed in the United States.”

As a result of the U.S. President’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the proposed rule allows a “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.

Albeit, a very significant caveat accompanies the proposed rule, which is, that, labeling a food product in accordance with the latter is completely voluntary. The U.S. Federal Trade Commission (FTC) takes a similar course of action. While the FTC regulates U.S. origin claims under its authority to act against deceptive acts and practices, foreign-origin markings on products are regulated primarily by U.S. Customs under the Tariff Act of 1930. The similarity in the rules is that neither Customs nor the FTC requires that goods made […]

By Jennifer Diaz|2023-03-14T10:25:17-04:00March 14, 2023|Food, U.S. Customs and Border Protection (CBP), U.S. Department of Agriculture (USDA), U.S. Federal Trade Commission (FTC)|0 Comments

New Court Rulings on Marijuana-Related Paraphernalia: Understanding the Impact on Importers

The marijuana industry is rapidly growing, with more and more states legalizing its use for medical and/or recreational purposes. With this growth, there is an increase in the importation of products such as grinders, storage containers, rolling paper, pipes, and vape pens, both for business and personal use. More businesses are asking why there is an issue importing such items when they only intend to sell and distribute within the many states where marijuana is legal for medical or recreational use and have established their regulations for marijuana-related products. It is still essential to remember, while many states have legalized marijuana for medical or recreational use, marijuana remains illegal under federal law.

This blog will address recent Court of International Trade (CIT) cases on this very topic and will be a part 2 to our previous blog covering U.S. Customs and Border Protection (CBP) seizures of drug paraphernalia.

CBP Authority

CBP has the power to seize “drug paraphernalia” products. This does not only cover importations of products for commercial use, but also items for personal use with individuals traveling internationally seeking entry into the United States. CBP’s website section: Know Before You Go – Prohibited and Restricted Items encourages individuals to contact CBP prior to traveling and make sure that prohibited or restricted items, such as drug paraphernalia, are not brought into the country, as they are not only subject to seizure pursuant to […]