Category Archives: Uncategorized

16 Jan

Spa Owner Sentenced to Prison for Illegal Sylicone Injections

Elva Navarro, of Hidalgo,Texas,  has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella

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
08 Oct

Florida DOH unveils new approach to medical license renewals

Licensees of the Department of Health are required to renew their licenses biennially in order to maintain the right to practice in the health care industry.  The DOH required medical doctors to renew their licenses in two groups: Group 1 – current license will expire at midnight, Eastern Time, January 31, 2014 Group 2 – current license will expire

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
23 Aug

Gaitan Law Group Successfully Reduces a $736,305.93 Overpayment to $6,826.00

  CMS sought recovery of an alleged overpayment in excess of $730,000 from a diagnostic laboratory, upon the conclusion and recommendation of Safeguard Services (SGS) to deny all claims submitted for 3,006 Medicare beneficiaries.  Mr. Gaitan and Mr. Suarez, of our health care practice group, appealed the overpayment claim through the reconsideration (second level appeal),

Read More
26 Jul

FSMA Update: FDA advances imported food safety initiatives, issuing proposed rules for FSVP and Third-party accreditation

Earlier today, the U.S. Food and Drug Administration (FDA) announced the publication of two proposed rules, as part of the implementation of the Food Safety Modernization Act (FSMA).  The proposed rules address the “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (FSVP) and ” Accreditation of Third-party Auditors”,  aimed at ensuring

Read More
17 Apr

Community Pharmacy Re-permitting Required Before July 1, 2012

Section 465.018, Florida Statutes was amended in 2011, by HB 7095 to require every community pharmacy that dispenses Schedule II and Schedule III controlled substances to be re-permitted by July 1, 2012. All owners, officers, and prescription department managers of the community pharmacy will need to submit fingerprints to the Department of Health as part of the permitting process; and the community pharmacy must implement written policies and procedures for preventing controlled substance dispensing based upon fraudulent representations or invalid practitioner-patient relationships. To avoid disruptions to a business, community pharmacies are advised to begin the permitting process immediately. For assistance and guidance with applying for a community pharmacy permit, developing policies and procedures for preventing controlled substance dispensing fraud and abuse, or to appeal a permit denial or revocation, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry, regularly representing pharmacies and pharmacist before regulatory bodies like the Florida Department of Health, and the Board of Medicine. Mr. Gaitan can be reached via e-mail at [email protected] or via telephone at 305.329.1462.

Read More
08 Mar

FDA issues warning letter to makers of AeroShot “caffeine inhaler”

On March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the

Read More