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How to Respond to an FDA Warning Letter

An FDA warning letter is essentially the equivalent of a “cease and desist.” If you’ve received a warning letter from the FDA, chances are something about your product hasn’t met FDA standards and they’re offering you the opportunity to make some necessary changes before your product is pulled from the market. Being issued a warning […]

Nationwide Dietary Supplement Recall

Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, LOT# R7-D5K1011H, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. FDA analysis has found the products to be tainted with Sildenafil and Tadalafil, which are the active ingredients in two […]

Requirements for USDA Certified Organic Foods

As awareness of potentially harmful ingredients in foods rises, the demand for organic products grows. Companies that are able to market organic foods stand to gain significant profit, however, there are a number of regulations that govern USDA organic labeling. Certain requirements must be met in order to claim that your product is indeed organic. […]

How Changes to Nutritional Labeling May Affect You

In May of 2016, the FDA made several changes to nutrition labeling requirements. If you manufacture a food product, these changes may affect the way you label your products. Here’s what you need to know. New Nutrition Labeling Requirements Increased size font for certain parts of the label. Food manufacturers must now increase the typeface […]

IMPORTERS, ARE YOU READY? THE DUE DATE IS AROUND THE CORNER

The FDA Foreign Supplier Verification Program (FSVP) due date is almost here for those importers who did not fall under a previous deadline.  FDA has determined that March 18, 2018 is the deadline for companies with less than 500 full time equivalent employees. The prior deadline for companies with over 500 full time equivalent employees […]

Are You Meeting DSHEA Requirements for Dietary Supplements?

Manufacturers of dietary supplements have a heavy burden to ensure the safety and efficacy of products they produce. There are strict regulations to adhere to as outlined in the Dietary Supplement and Health Education Act (DSHEA). Is your facility meeting these requirements? Find out now and how to get help becoming certain that your supplements are meeting […]

How to Maintain Compliance When Manufacturing Cosmetics

While cosmetics are one of the least regulated group of products by the Food and Drug Administration (FDA), there are still some guidelines that need to be followed. This is particularly true if you’re a small business making cosmetics at home, a salon, or small facility and aren’t manufacturing on a large scale. Here’s how […]

The Florida Bar Leadership Academy Committee 2020

Capote Law Firm is proud to announce that attorney Lisa Capote has been appointed to the Florida Bar Leadership planning committee. Mrs. Capote is a Leadership Academy Class 3 alumni, having participated in the program during 2015 – 2016.  The Wm. Reece Smith, Jr. Leadership Academy is a multi-session training program designed to assist a […]

Why Classify Your Medical Device for the FDA?

Classifying your medical device with the FDA can seem overwhelming. It’s important to take things one step at a time. There are three major classifications for medical devices under FDA law. It’s crucial to understand why you need to classify your medical device. What Requirements Should You Be Meeting While Designing or Manufacturing Your Device? Learning […]

Is Your Product Label Up to Code?

The FDA strictly regulates what you put on your product label if you’re manufacturing or selling dietary supplements. Recently, a popular essential oil and aromatherapy company came under FDA fire for claims of treating and curing diseases. This is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Here’s what you need […]

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