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Understanding Dietary Supplements and FDA Regulations

Welcome to our blog series on dietary supplements and FDA regulations! In this first post, we'll provide an overview of dietary supplements and their purpose, as well as how they are regulated by the FDA.

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Lisa Capote Elected Regional President for HNBA, Region VIII (Florida)

Lisa Capote has been elected Hispanic National Bar Association Regional President of Florida. Ms. Capote focuses on global compliance for food, logistics, pharmaceutical, healthcare, life sciences and medical device industries, including FDA and international trade compliance.

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Lisa Capote Awarded Florida Trend's Legal Elite 2018

Each year Florida Trend magazine presents a roster of attorneys chosen for recognition by their peers. According to Florida Trend the lawyers listed here exemplify a standard of excellence in their profession and have garnered the respect and esteem of their colleagues.

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CBP dice que el país de origen de los granos de café es el país de donde el grano es tostado.

La Oficina de Aduanas y Protección de Fronteras (CBP) de los EE. UU. Ha emitido una determinación final de que el país de origen de los granos de café es el país donde se asan los granos de café.

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CBP Says Country of Origin for Coffee Beans Is Country of Roasting

U.S. Customs and Border Protection (CBP) has issued a final determination that the country of origin of coffee beans is the country in which the coffee beans are roasted. The coffee beans in the final determination are produced from raw green coffee beans imported into either Candara or US in their natural state.

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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.

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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 FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil which is structurally similar to sildenafil.

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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.

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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.

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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).

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