labeling Archives | Customs & International Trade Law Blog

Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?

A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. Manufacturers, importers, distributors, and others engaged in the production or sale of products claiming to mitigate or “kill” COVID-19 should be more cautious than ever when developing product claims for both product labels and marketing material or alternatively, confirm products comply with the numerous regulations governing COVID-19 cleaning products.

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By Jennifer Diaz|2021-10-12T14:46:03-04:00March 15, 2021|Best Practices, Customs Expert, Enforcement, Events, International Law, International Trade, Labeling, U.S. Food and Drug Administration (FDA)|Comments Off

Here are the Major Changes FDA is Proposing to Make to the Sunscreen Rule!

On February 26 2019, the United States Food and Drug Administration (FDA) proposed a rule that would alter the regulations associated with the manufacturing and selling of sunscreen, as well as other sun-care related products. Since the closing of the comment period on May 28^th, 2019, FDA has received over one thousand comments from industry players voicing their concern over various aspects of the proposed measures.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

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By Jennifer Diaz|2021-10-28T15:33:57-04:00September 10, 2019|International Law, International Trade, International Travel, U.S. Food and Drug Administration (FDA)|3 Comments

Dietary Supplement Labeling Do’s and Don’ts

You don’t want to miss this one! The U.S. Food and Drug Administration (FDA)’s top rationales for detention of dietary supplements include non-compliant labeling, products subject to an Import Alert, unauthorized claims, and more. Consistently, we encounter dietary supplements with outrageous claims turning the intended use of the products into “drugs” instead of Supplements. In this webinar we will explore the confusion surrounding suitable structure/function claims versus disease claims made on Dietary Supplements and the nuances involved behind the FDA’s approach of deciding what constitutes a valid claim. Participants will also what’s required on a dietary supplement label, best practices and how to handle FDA enforcement actions, and much more! Don’t delay, RSVP Today!

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By Jennifer Diaz|2021-10-29T15:18:18-04:00December 5, 2018|Best Practices, Events, Import, International Trade, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

FDA’s Declared War on Sugar

Take a look at any food label. Check out the back panel entitled “Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars.

On May 20, 2016 the FDA finalized the new Nutrition Facts label final rule for packaged foods. It was the first major update, and regulation, to the nutrition facts label in 20 years. The FDA’s regulation targeted sugars, in particular “added sugars”, and provided a major update to the amount of nutrients people customarily consume. Additionally, the nutrition facts label received a face lift.

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By Jennifer Diaz|2022-07-06T15:25:53-04:00June 3, 2016|Food, Import, U.S. Food and Drug Administration (FDA)|3 Comments

FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

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By Jennifer Diaz|2021-11-09T15:00:57-05:00July 8, 2014|Best Practices, Food, FSMA, Gluten Free, Import, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Finally Issues Definition of “GLUTEN FREE”!

HOT OFF THE PRESS!!! FDA issued the update below today DEFINING the term "Gluten Free". As a Celiac, this is extremely exciting news! The reason this is a HUGE deal? Us Celiac's need to know we can trust food products that are labeled "gluten free". If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

By Jennifer Diaz|2021-11-10T14:13:47-05:00August 2, 2013|Best Practices, Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|Comments Off

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.

By Jennifer Diaz|2021-11-10T14:57:05-05:00October 11, 2011|Cosmetics, Import, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Finally Getting Tough on False Food Claims

The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims on their food and drink products, including those marketed to children. Some food products brazenly claim to increase a person's immune system, reduce the chance or getting a cold, or even cure cancer. Are they really believable?

By Jennifer Diaz|2010-03-09T10:31:36-05:00March 9, 2010|Food|Comments Off