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. An AV Preeminent-Ra...
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. Lisa Capote has been honor...
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. Los granos de café en la determinación final se producen a partir de granos de café verde crudo impor...
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 the...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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 ...
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...
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”...
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...
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...
A new web page was announced on 4 August last by the FDA to provide the industry with information on the new regulation on the nutritional information and sizes of portions in the labels. Currently the update of the labels is voluntary, this until 26 July 2018 or 26 July 2019 for companies with ...
Una nueva página web fue anunciada el pasado 4 de Agosto por la FDA para proporcionar a la industria la información sobre la nueva regulación sobre la Información Nutricional y tamaños de porciones en las etiquetas. Actualmente la actualización de las etiquetas es voluntaria, ésto hasta el 26 Ju...
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...
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...
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...
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 ...
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...
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...
