Bioengineered Food Labeling

In our July 27, 2018 blog , we explained what bioengineered (BE) food is and informed you about the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) new proposed rule for BE foods. The new rule is a result of the 2016 amendment to the Agricultural Marketing Act of 1946, which would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. This proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. The standardized disclosure of information will facilitate food purchasing for consumers by eliminating the current uncertainty when purchasing food; effectively improving overall consumer confidence, without harming food manufacturing; and providing farms and production companies a logical, consistent standard for future labeling and packaging. […]

Peruvian Timber on the Hot Seat

In a press release, the Office of the United States Trade Representative (USTR) directed United States Customs and Border Protection (CBP) to block future timber imports from a Peruvian exporter, Inversiones Oroza SRL for three years or until it is determined that the company has complied with all applicable Peruvian laws, regulations, and other measures, whichever is shorter. This is the first enforcement action taken by the […]

WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

Who knew dental floss was a medical device regulated by the U.S. Food and Drug Administration (FDA)? What about contact lenses, sunglasses, tongue depressors, dental floss, or bedpans? How about pacemakers? You guessed it, they all are!

One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

What is a Medical Device? […]

HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now?

Our office has increasingly received requests for guidance on importation of marijuana paraphernalia products to the U.S. where twenty-six (26) states have legalized the use of marijuana for medical purposes and/or personal consumption such as California, Massachusetts, Maine and Nevada. The purpose of this article is to dispel the confusion as to why paraphernalia products (grinders, storage containers, rolling paper, pipes, vape pens, etc.) are continuously being seized by U.S. Customs and Border Protection (CBP), even when such products may be used by tobacco smokers. It is important to address the realities between federal and state laws regulating drug paraphernalia products so importers can avoid CBP’s enforcement of U.S. Laws.

Why Does CBP Stop Drug Paraphernalia?

  • CBP secures America’s borders at and between ports of entry by stopping inadmissible people and illicit goods. The Tariff Act of 1789 provides one of CBP’s core functions: to act as the leading federal agency in determining the admissibility of goods that may enter the Commerce of the United States. Even though each State has internally legalized marijuana either for medical or recreational purposes, CBP still has the express power to authorize or not any merchandise that comes into the U.S. Thus, CBP can detain and seize “drug paraphernalia” even if you did not intend to use the product that purpose pursuant to 19 U.S.C. § 1595a(c) stating a violation of 21 U.S.C. § 863.

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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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