Blog

Oct. 3, 2017

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.

Sept. 22, 2017

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.

Sept. 1, 2017

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.

Aug. 1, 2017

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.

June 30, 2017

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).

June 13, 2017

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.

May 30, 2017

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.

May 17, 2017

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.

May 10, 2017

Classifying your medical device with the FDA can seem overwhelming. It's important to take things one step at a time.

May 1, 2017

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.