U.S. Food and Drug Administration (FDA) Archives - Page 36 of 42

Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements

Today, May 25, 2012 is officially designated as Don’t Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn’t want you to fry either. On June 18, 2012 the FDA’s new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013.

By Jennifer Diaz|2022-07-08T15:46:55-04:00May 25, 2012|Import, U.S. Food and Drug Administration (FDA)|1 Comment

2012 International Boston Seafood Show

The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center. The Show attracts 19,000 visitors, and is the largest seafood show in North America. See www.bostonseafood.com. I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know – now.

My topic is “Food Safety Compliance under the New Food Safety Modernization Act of 2011.” My fellow panelists discussing the FSMA, and import safety generally, include Ted Poplawski from the FDA, Judith Webster from U.S. Customs and Border Protection (CBP), Howard Tennen from Quirch Foods, Dean Leaman of ABC Research Laboratories, and Dan Fone of NSF International. Since 80% of the seafood consumed in the United States is imported, compliance with the food safety laws and regulations that have now been implemented by the FDA, in cooperation with CBP, is critical.

There were a record number of FDA Import Alerts for seafood in 2011, and a higher number of imported shipments of seafood are now the subject of Detention Without Physical Examination (DWPE). What is surprising to many people is that the seafood is not just being stopped and inspected from China, but also Vietnam, Chile, and Canada, to name a few. Moreover, seafood fraud in many forms such as species substitution or false country of origin to avoid the payment of anti-dumping duties is now being discovered by the FDA, CBP, and NOAA. Criminal prosecutions and civil penalties by […]

By Jennifer Diaz|2015-12-01T06:52:54-05:00March 12, 2012|Food, FSMA|0 Comments

HOW TO GET OFF THE FDA BLACK LIST (Import Alert List)

What is the Black List?

The United States Food and Drug Administration (FDA) has authority from Congress to place an importer, manufacturer, shipper, grower, geographic area, or country on a “detention without physical examination” (DWPE) list (aka the FDA’s black list). To check if a company you are doing business with is on such a list, check FDA’s Import Alert page, you can search by country, company, etc. If your company is on this list, any merchandise you import may be detained as soon as it is offered for entry into the United States. You will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days. The company/country, etc. will remain on this black list, until information is presented to the FDA that proves the merchandise is no longer violative.

How to Get Off the Black List
FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the black list. The specific method to use to get off the black list is directly related to why you were placed on the black list in the first place. For example, if a food product was placed on the automatic detention list because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must enter the U.S., and at least one […]

By Jennifer Diaz|2022-08-09T10:33:12-04:00February 14, 2012|Import Alert, U.S. Food and Drug Administration (FDA)|0 Comments

Recent FDA Developments Handbook

I authored “Recent Developments in Food and Drug Law, 2012 Edition” which was just published by Thomas Reuters. It is part of a series called “Inside the Minds” written by attorney thought-leaders in food and drug law from the top law firms across the United States. It analyzes the latest food and drug laws, regulations and policies that affect food and drug companies. It also focuses on violations by persons and companies, and how to successfully defend any investigation by the U.S. Food and Drug Administration (FDA) without having to go to court.

The full title of the 408 page publication is “Recent Developments in Food and Drug Law, 2012 Ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, and Developing Compliance Practices”. The book is written for C-level executives to learn the very latest trends about food and drug law enforcement and compliance requirements by the FDA. According to the press release

This Aspatore legal title provides an authoritative, insider’s perspective on complying with FDA regulations and staying up-to-date on the latest trends in food and drug law.

The Food Safety Modernization Act (FSMA) gave the FDA recall authority, so companies must know how and when to do a voluntary recall and when a product is safe and effective or, alternatively, defective. The book will precisely explain the labeling requirements acceptable to the FDA and when the statements about the use of a product may be false and misleading so that the product is considered to […]

By Jennifer Diaz|2015-12-01T06:49:05-05:00January 22, 2012|FDA Issues, Food|0 Comments

How to Comply with International Inconsistencies in FDA Cosmetic Labeling Requirements

The U.S. Food and Drug Administration (“FDA”) has strict labeling requirements for cosmetic products. One area that consistently causes confusion among companies that distribute cosmetic products to countries on different continents is the area of labeling. Different products have different labeling requirements depending on the application of the product, the type of ingredient being labeled, the size of the product, and the country to which the product will be shipped. For example, the rules regarding how to describe color additives for products entering the U.S. are different than those for Canada and Europe.

Fortunately, it is possible to comply with the labeling requirements for the U.S. as well as Canada and Europe using only one label. In fact, it can even be accomplished with a product bearing a label as small as that of mascara. Accomplishing this is greatly beneficial to these companies because they can take advantage of economies of scale and taper production costs by merely having one label printed to be distributed to several countries. However, this is a delicate maneuver that, if not done properly, will likely result in seizure and detention by the FDA or a foreign country’s equivalent agency. This will cause delays in the shipments, and may cause civil penalties and forfeiture of the products.

To avoid this common mistake and take advantage of the fact that one label may be used throughout the U.S., Canada, and Europe, you should contact an attorney well versed in the FDA regulations. Taking this precautionary measure is an […]

By Jennifer Diaz|2022-07-06T13:32:16-04:00October 11, 2011|Cosmetics, FDA Issues, Import|0 Comments

Previous 353637 Next