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FDA Cuts Nearly a Quarter of Food Facilities From Its Database

Earlier this year, the FDA cut 59,420 food facilities from their registration database, nearly a quarter of facilities registered. Food facilities must renew their registration between October and December of every even-numbered year. If a company fails to do so, the registration they previously had expires, and they are removed from the database after the...
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Are Color Additives Safe?

Color additives such as what you see in many foods and beverages are dyes, pigments, and other substances that alter the color of a food, drug, or cosmetic item (or even the human body). Common items that contain dyes are fruit punches, toothpaste, cough syrup, and cereal.  The FDA states that color additives are safe...
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Claim Labeling Requirements from the FDA

Accuracy in labeling a product is one of the most important elements a company must incorporate into its product labeling. Claims and warnings for potential allergens (such as announcing the product was made in a facility that also processes peanuts, or it may contain soy). The Consumer Protection Act of 2004 states that companies must...
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The 115 Year History of FDA Regulation

The Food and Drug Administration (FDA) has been regulating good safety since its first act in 1906 – the Pure Food and Drug Act. The act was passed shortly after the publication of Upton Sinclair’s infamous novel, The Jungle, when President Theodore Roosevelt read it and was later appalled by what he learned was happening....
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FDA Pulls All Food From Little Hatch

This summer, the FDA issued a warning for Little Hatch’s products as they were linked to severe health concerns. In late May, the parent company Interstate Food products voluntarily recalled Little Hatch’s Jalapeno Cream Cheese. Another recall notice was given almost a week later for queso, and in mid-June, internal testing confirmed that the salsa...
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FDA Breakthrough With Orthopedic Implants

The SmartFuse, Intelligent Implants Ltd.’s new orthopedic implant, has been cleared for use by the Food and Drug Administration (FDA) through FDA device registration. The technology remotely stimulates and controls bone growth and monitors for clinical decisions that can be made instantaneously. The new device is clear for first use in patients who need lumbar...
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New FDA Challenge to Develop Traceability in Food Safety Efforts

The Food and Drug Administration has launched an initiative to bring on change to the development of affordable, technology-based traceability tools to protect people and animals from contaminated food. This will allow rapid identification of food sources and assist them in removing contaminated products from the market as quickly as possible.  Formally known as “The...
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British Insomnia Device Hits US Markets

SleepCogni is now registered for medical use by the Food and Drug Administration (FDA). The device is data-supported, targeting those who suffer from insomnia, and aims to break cognitive cycles that prevent sleep. Preliminary analysis shows that the device does, in fact, reduce insomnia (as measured by Insomnia Severity Index) within seven days of use...
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Nevada Water Bottle Company Must Stop Production for Failure to Comply

The Food and Drug Administration recently announced that a Nevada-based water bottle company Real Water Inc. will need to stop operations until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) along with other requirements.  The FD&C Act is a set of laws that oversees food safety, drugs, medical devices, and cosmetics,...
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