FDA shuts down Miami company for non-compliance with GMPs
SILVER SPRING, Md. – The Food and Drug Administration on Monday effectively shut down Sunset Natural Products for manufacturing and distributing adulterated dietary supplements, following a ruling Friday issued by U.S. Magistrate Judge Edwin Torres for the U.S. District Court for the Southern District of Florida. Torres entered a consent decree of permanent injunction against the company and its two owners, Teresa Martinez and Elsy Cruz.
Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act.
“The FDA is committed to protecting the public health by ensuring dietary supplement makers operate in accordance with the law,” stated Melinda Plaisier, associate commissioner in the FDA’s Office of Regulatory Affairs. “Good Manufacturing Practice regulations are designed to safeguard consumers and violation of these requirements will result in enforcement action.”
The FDA issued Sunset Natural Products a Warning Letter on March 19, 2013, for violations of the cGMP requirements as well as unapproved drug claims. The FDA’s follow-up inspections in 2014 found that although the company removed drug claims from its products, it failed to bring its manufacturing operations into compliance with cGMP.
The consent decree prohibits the company and its owners from marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from the FDA to resume operations.
Medela makes breastfeeding simpler for moms
McHENRY, Ill – Medela on Monday announced the launch of the MyMedela app, now available for Android and iPhone, that offers digital breastfeeding support for pregnant, new and experienced mothers. This 24/7 resource provides mothers with robust tracking tools, along with personalized, expert advice on nursing and pumping. It delivers proactive guidance as well as tips that can lead to a positive breastfeeding experience for mother and child.
MyMedela offers a confidence assessment to understand mom's strengths and focus on her goals to then deliver customized feedback and support based on mom's answers and other data entries. The new app also provides a problem solver tool for answers to common breastfeeding questions, featuring tips from expert healthcare professionals.
In addition, the app can:
- Track breastfeeding and pumping routines (e.g., time spent, volume and frequency);
- Record information about baby's growth and daily activities, such as height, weight, sleep and diapers;
- See snapshots of mom and baby's activities on easy-to-read dashboards; and
- Receive personalized reminders, alerts and notifications that celebrate accomplishments and help moms manage breastfeeding challenges and goals.
The Centers for Disease Control and Prevention reports that while 79% of moms initiate breastfeeding, only 41% of moms are breastfeeding exclusively at three months. While breastfeeding is the most natural way to feed a baby, many mothers – even seasoned ones – need assistance and encouragement to ensure the most successful experience for baby and mom. Results from a survey conducted by Medela indicated that 70% of mothers do not meet their breastfeeding goals. New mothers who are worried about their breastfeeding success are more likely to give up.
Study suggests upper limit of systolic blood pressure too high
CHICAGO – A recent study found that lowering one type of blood pressure to well below the commonly recommended level also greatly lowered the number of cardiovascular events and deaths among people at least 50 years old with high blood pressure.
“When the amount or type of blood pressure medication was adjusted to achieve a systolic blood pressure target of 120 mmHg compared to the higher target of 140 mmHg, cardiovascular events such as heart attack, stroke and heart failure were reduced by almost one-third, and the risk of death by almost one-fourth," stated Lynne Braun, a nurse practitioner in the Rush Heart Center for Women. “That’s important information, because more lives may be saved and more deaths may be prevented if we maintain lower blood pressure in our patients.”
Approximately one out of every three adults in the U.S. has high blood pressure and is subsequently at greater risk of heart disease, stroke, kidney failure and other health problems.
“Another thing that was important to note in this study was that it examined a very diverse population. It seems to apply across the board,” Braun said, who was not involved in the study.
The National Heart, Lung and Blood Institute, which sponsored the study, announced some preliminary results on Sept. 11. The findings of the Systolic Blood Pressure Intervention Trial, or SPRINT, were so definitive that it was stopped earlier than planned in order to share the results quickly.
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