U.S. Food and Drug Administration (FDA) Archives - Page 26 of 42

FSMA: Stay Compliant with DTL’s ‘PICTURE’!

Each year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant. […]

By Jennifer Diaz|2018-09-06T15:06:14-04:00January 12, 2017|FDA Issues, Food, FSMA, U.S. Food and Drug Administration (FDA)|2 Comments

19 Antibacterial Soap Ingredients to be Banned by the FDA!

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.

Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection.

Popular as antibacterial products may be, beginning September 2017, many of them may no longer be marketed as such, based on a Final Rule (78 FR 76444) issued by the U.S. Food & Drug Administration (FDA) on September 6, 2016. This Final Rule comes after several years of an FDA investigation into the effectiveness and potential hazards of antiseptic agents in personal care products. The most popular antiseptic agent in these products is triclosan, which, along with eighteen (18) other antiseptic agents under this Final Rule, is now banned when used for antibacterial purposes in hand and body washes. […]

By Jennifer Diaz|2022-07-07T11:50:26-04:00November 17, 2016|Customs Expert, FDA Issues, International Law, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

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

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.

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 […]

By Jennifer Diaz|2016-06-03T00:40:17-04:00June 3, 2016|Enforcement, FSMA, Labeling, U.S. Food and Drug Administration (FDA)|0 Comments