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How to Respond to an FDA Warning Letter

Posted by Andrina Capote | Oct 03, 2017 | 0 Comments

An FDA warning letter is essentially the equivalent of a “cease and desist.” If youve received a warning letter from the FDA, chances are something about your product hasnt met FDA standards and theyre offering you the opportunity to make some necessary changes before your product is pulled fr...

Nationwide Dietary Supplement Recall

Posted by Andrina Capote | Sep 22, 2017 | 0 Comments

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 a...

Requirements for USDA Certified Organic Foods

Posted by Lisa Capote | Sep 01, 2017 | 0 Comments

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 i...

How Changes to Nutritional Labeling May Affect You

Posted by Lisa Capote | Aug 01, 2017 | 0 Comments

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. Heres what you need to know. New Nutrition Labeling Requirements Increased size font for certain parts of the label. Foo...

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

Posted by Lisa Capote | Jul 03, 2017 | 0 Comments

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 wi...

Are You Meeting DSHEA Requirements for Dietary Supplements?

Posted by Lisa Capote | Jun 30, 2017 | 0 Comments

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 ...

How to Maintain Compliance When Manufacturing Cosmetics

Posted by Lisa Capote | May 30, 2017 | 0 Comments

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 youre a small business making cosmetics at home, a salon, or small facility and arent manufacturing ...

The Florida Bar Leadership Academy Committee 2020

Posted by Lisa Capote | May 17, 2017 | 0 Comments

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-s...

Why Classify Your Medical Device for the FDA?

Posted by Lisa Capote | May 10, 2017 | 0 Comments

Classifying your medical device with the FDA can seem overwhelming. Its important to take things one step at a time. There are three major classifications for medical devices under FDA law. Its crucial to understand why you need to classify your medical device. What Requirements Should You Be ...

Is Your Product Label Up to Code?

Posted by Lisa Capote | May 01, 2017 | 0 Comments

The FDA strictly regulates what you put on your product label if youre 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...

Does Your Cosmetic Contain Prohibited Ingredients?

Posted by Lisa Capote | Mar 24, 2017 | 0 Comments

If youre working to get your cosmetic on shelves, the process can seem challenging and at times, even frustrating. One way to increase your chances of success is to ensure your cosmetic does not contain ingredients prohibited by the FDA. Heres what you should know. Cosmetics Are Not “Approved”...

How to Classify Your Medical Device for the FDA

Posted by Lisa Capote | Mar 09, 2017 | 0 Comments

When you have a medical device to register with the FDA, the first step is to classify the device. The devices classification will help identify the it within the FDA and determine the devices level of risk. By understanding how to classify your medical device, you can ensure your device is pro...

FDA working on the updating “Healthy” Claim

Posted by Lisa Capote | Nov 09, 2016 | 0 Comments

The FDA is planning to update the regulations regarding nutrient content and health claims to conform to the updated nutrition labeling regulations published in May, 2016. FDAs Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not l...

GMO labeling Bill is About to Become Law, Are You Ready?

Posted by Lisa Capote | Aug 08, 2016 | 0 Comments

The Senate and House have approved legislation authorizing USDA to establish a National Bioengineered Food Disclosure Standard, in short, GMO Labeling. This legislation applies to all products for human consumption except those that are served in restaurants and similar establishments. The prod...

Lisa Capote Participates in Florida Bar Leadership Academy

Posted by Lisa Capote | Jul 01, 2015 | 0 Comments

Partner Lisa Capote was selected to participate in the Florida Bar Wm. Reece Smith, Jr. Leadership Academy, a multi-session training program designed to assist a diverse and inclusive group of lawyers in becoming better leaders within the profession, in their chosen path, while enhancing their le...

AV Preeminent Rating

Posted by Lisa Capote | Jun 11, 2015 | 0 Comments

Capote Law Firm is proud to announce our partner Lisa Capote has received a Martindale Hubbell AV Preeminent rating. Martindale Hubbells peer review rating is based on five key areas: legal knowledge, analytical capabilities, judgment, communication ability and legal experience. AV Preeminent is...

FDA Registration – OTC Drugs

Posted by Lisa Capote | Jun 01, 2012 | 0 Comments

The Division of Compliance Risk Management and Surveillance oversees the FDA registration for over-the-counter drugs (OTC Drugs). FDA considers FDA registration for OTC drugs a key component of its FDAs ability to monitor drug safety. As of June 1, 2009, FDA no longer accepts FDA registrations ...

Food Safety Modernization Act (FSMA) (FY 2012)

Posted by Lisa Capote | Mar 26, 2012 | 0 Comments

How does FDA identify a high-risk (HR) facility? The agency is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FDamp;C Act, which are: The known safety risks of the food manufactured, processed, packed, or held at the facility; The compli...

Recordkeeping Under Food Safety Modernization Act

Posted by Lisa Capote | Mar 14, 2012 | 0 Comments

The Food Safety Modernization Act was signed a little over a year ago and FDA continues to make strides in implementing all the new FDA laws required under the Congressional mandate. The latest proposed FDA law issued February 2012 addresses establishment, maintenance, and availability of records...

Food Safety Modernization Act – A Importer’s Guide

Posted by Lisa Capote | Mar 08, 2012 | 0 Comments

January 2011 marked a monumental time for food importers.  On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act.  The new regulation will place responsibility and accountability for food safety on the importer bringing food products into this country. Importer...

Holiday food safety tips | FoodSafety.gov

Posted by Lisa Capote | Dec 22, 2011 | 0 Comments

The holiday season is a time for celebration and great food. Dont let merriment change to misery because food makes you or others ill. Dont give the gift of food poisoning; Keep things clean Wash hands with warm water and soap for 20 seconds before and after handling any food. Wash food-co...

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