Tag Archives: Ann Marie Gaitan

30 Apr

FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss,  energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year

Read More
23 Apr

USDA to expand fresh produce imports from Peru allowing importation of papayas, oversized mangoes, peppers and citrus

Today, the U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Services (APHIS) announced  the potential expansion of fresh produce imports from Peru including papayas, oversized mangoes, peppers, and citrus, stating in its press release: [t]he U.S. Department of Agriculture (USDA)and the Peruvian Ministry of Agriculture (MOA) met in Washington, D.C., to recognize recent market

Read More
21 Apr

FDA publishes draft guidance on foreign clinical data for medical devices in support of 510(k) premarket submissions

Today the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices The special considerations that apply

Read More
07 Apr

Pesticide Companies Selling Antimicrobial Pesticide with Unapproved Claims to Pay Civil Penalties to EPA

Integrated Environmental Technologies (IET), a South Carolina based pesticide registrant, and Seriously Clean, Ltd., of Nixa, Mo., a firm that served as an authorized distributor of IET’s product under a different brand name, have agreed to pay civil penalties of $87,344 and $91,829, respectively, to the Environmental Protection Agency (EPA) to settle alleged violations of

Read More
21 Jan

FTC target deceptive advertisers of weight-loss products

On January 7, 2014, the Federal Trade Commission (FTC) announced a law enforcement initiative to stop deceptive advertising claims to relating to weight- loss products, from food additives and skin cream to dietary supplements. Recognizing that Americans spend billions of dollars every year on supplements, foods and devices in hopes of improving their health and

Read More
04 Oct

FDA issues Warning Letter to CA Seafood Importer for Seafood HACCP Violations

The U.S. Food and Drug Administration (FDA) issued a warning letter to Jin Han International, Inc., d/b/a Pacific Foods Co., after a facility inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)”. According to the letter, the

Read More
26 Sep

FDA to begin regulating mobile medical applications

The FDA has issued Mobile Medical Applications Final Guidance regarding the monitoring of Smartphone software applications with medical applications as a “medical device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Consistent with FDA’s existing regulatory approach that considers functionality rather than platform, the FDA intends to exercise its jurisdiction over those mobile

Read More
24 Sep

Ann Marie Gaitan offers FREE webinar on medical device regulation

Due to the overwhelming positive response after Mrs. Gaitan’s speaking engagement at the FIME International Medical Exposition on “How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers”, Mrs. Gaitan will be presenting a webinar on basic FDA requirements for medical devices on Monday, September 30th, 2013. “Introduction to FDA Medical Device Regulatory Requirements”

Read More