Labeling

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

Co-Authored by Denise Calle

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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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 28th, 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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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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What: Dietary Supplement Labeling Do’s and Don’ts
When: December 11th, 2018, 12:00PM-1:00PM EST

RSVP TODAY!

In this webinar you will learn:

  • What is required on a Dietary Supplement Label
  • How to market your dietary supplement and comply with FDA labeling requirements
  • How to make FDA compliant claims on your dietary supplement products
  • How to distinguish between structure function claims and disease claims
  • How to implement a process to accurately label your dietary supplement products according to current Good Manufacturing Practice (cGMP) and labeling regulations
  • What to do to avoid FDA enforcement actions
  • What to do if FDA detains your dietary supplement
  • What to do if your product is on an Import Alert list

Who Should Attend?

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FDA Targets Vending Machine Operators

Co-Authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law. 

Since April 2008, pursuant to New York City Health Code Section 81.50, all Starbucks (and many other restaurants) in New York City have been required to display the calories of each of the menu items. A subsequent study found that this mandatory calorie posting influenced consumers in NYC, causing average calories per transaction to drop by 6%. The study also found that calorie posting did not cause any significant change in Starbucks’ overall revenue.

Now, owners and operators of vending machines across the U.S. are next. Back in December of 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”. This rule is codified at 21 CFR 101.8, and requires vending machine operators who own or operate twenty (20) or more vending machines, or who voluntarily register with FDA to be covered, to
declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase. According to the December 2014 final rule, covered vending machine operators must comply by December 1, 2016.

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By |2022-07-07T11:44:26-04:00September 1, 2016|Best Practices, FDA Issues, Food, Labeling|0 Comments

FDA’s Declared War on Sugar

Nutrition FactsTake 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.

Total Sugars and Added Sugars

Total Sugars, Sugars, and Added Sugars, what’s the difference? Total sugars will be replacing the declaration of sugars in the label. Total sugars include all sugars present in the food product, including added sugars. Sugars include the sugar content of the main ingredients. For example, if you have a juice, sugars represent the sugar level in the fruit added to the juice. Added sugars are either added during the processing of foods, or when packaged. Food manufacturers utilize added sugars to make products sweeter or to include […]

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