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Posts for tag: FDA

By contactus@priority-pediatrics.com
July 07, 2019
Category: Nutrition
Tags: pregnancy   nutrition   FDA   Mercury   Fish   Diet Advice  

FDA Updates Advice on Eating Fish for Pregnant Women, Children

Megan Brooks, July 03, 2019

The US Food and Drug Administration (FDA) has updated advice on fish consumption for women who are pregnant or may become pregnant, breastfeeding mothers, and young children, putting more focus on the health benefits of seafood.  

"Fish and shellfish are an important part of a well-rounded diet. However, we know many parents worry about mercury in fish and even choose to limit or avoid fish because of this concern. In fact, women in the US who are pregnant are consuming far less than the recommended amount of seafood," Susan Mayne, PhD, director of the FDA's Center for Food Safety and Applied Nutrition, said in a news release.

"Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat," said Mayne.

Choose Wisely

In January 2017, the FDA and Environmental Protection Agency (EPA) released a reference chart to help consumers more easily understand the types of fish to eat more or less of, based on their mercury levels.

The information in the chart remains the same. However, the revised advice issued July 2 expands information regarding the benefits of fish as part of a healthy diet by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans. The advice pertains to people aged 2 and older.

"While it is important to limit mercury in the diets of women who are pregnant or breastfeeding and young children, many types of fish are both nutritious and lower in mercury," the FDA said in the update.   

"The revised advice highlights the many nutritional components in fish, many of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for heart health benefits and lowering the risk of obesity," the FDA said.

Fish provides protein; healthy omega-3 fats; more vitamin B12 and vitamin D than any other type of food; iron, which is important for infants, young children, and women who are pregnant or who could become pregnant; and other minerals such as selenium, zinc, and iodine, the FDA notes.

Last month, the FDA announced it would allow certain "qualified" health claims stating that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease.

The FDA continues to recommend that adults eat at least 8 ounces of seafood per week based on a 2000 calorie diet.

For an adult, one serving is 4 ounces (about the size and thickness of an adult's palm). Adults should eat two to three servings a week from the "Best Choices" list (or one serving from the "Good Choices" list). For children, one serving is 1 ounce at age 2 and increases with age to 4 ounces by age 11.

Women who are pregnant or breastfeeding should consume between 8 and 12 ounces of a variety of seafood per week from choices that are lower in mercury.

The 36 types of seafood on the best choices list include salmon, shrimp, pollock, canned light tuna, tilapia, catfish and cod, flounder, haddock, crab, clams, and sole. Nineteen varieties make the good choices list and include bluefish, halibut, mahi mahi, grouper, monkfish, rockfish, snapper, and striped bass (ocean).

The FDA recommends that everyone avoid seven fish that may be high in mercury: king mackerel, marlin, orange roughy, shark, swordfish, tilefish (Gulf of Mexico), and bigeye tuna.

The updated advisory also cautions that some fish caught by family and friends, such as larger carp, catfish, trout, and perch, may contain unknown amounts of mercury or other contaminants. It advises checking local advisories for information on how often it's safe to eat those fish. If there is no advisory, the FDA advises eating only one serving and no other fish that week.

 
By contactus@priority-pediatrics.com
April 25, 2017
Category: Recalls

FDA: More Homeopathic Teething Products Recalled

 
From AAP News 4/2017

 

Homeopathic teething tablets are being recalled due to potential health risks   to children, according to the Food and Drug Administration (FDA).

Standard Homeopathic Company in Los Angeles is voluntary recalling Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, which contain inconsistent amounts of belladonna, a toxic substance, that may differ from the calculated amount on the label.

“FDA reminds consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products,” the agency said in its alert to consumers.

The Hyland’s tablet recall follows FDA warnings in September and January and a recall of similar products from another manufacturer in November.

Standard Homeopathic Company said it stopped manufacturing the teething products in October 2016. Customers who still have these products should contact the manufacturer at 800-991-3376.

If a child experiences health issues potentially related to the tablets, contact the child’s health care provider. Those issues may include seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation, according to the FDA.

Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.

By contactus@priority-pediatrics.com
February 03, 2017
Category: Teething

FDA confirms elevated toxin levels in homeopathic teething tablets

The FDA announced today that laboratory analysis revealed inconsistent levels of belladonna, a potentially toxic ingredient, in certain homeopathic teething tablets for infants and children.

As some tested products exhibited belladonna levels far exceeding the amount noted on the label, the agency has urged consumers to stop using these products or dispose of any currently in their possession.“The body’s response to belladonna in children under 2 years of age is unpredictable and puts them at unnecessary risk,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.” We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

Following the results of laboratory analysis, the FDA contacted the manufacturer of Hyland’s homeopathic teething products, Standard Homeopathic Company, regarding a recall of products labeled as containing belladonna; however, at this time, the company has not agreed to conduct a recall.

Homeopathic teething remedies have not been evaluated or approved by the FDA for safety and efficacy, and in September 2016, the agency warned against the use of these products after receiving adverse event reports, including 10 deaths. Although the causes of the deaths were uncertain, the FDA noted that the products contained potentially dangerous levels of belladonna, a toxin from a poisonous plant also known as ‘deadly nightshade’.

In November 2016, Raritan Pharmaceuticals recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

According to the FDA, consumers who have purchased homeopathic teething tablets and gels, distributed by CVS, Hyland’s and possibly other retail stores should seek immediate medical attention if their child experiences seizures, trouble breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after use.

The FDA has asked health care professionals and patients to report adverse events or side effects related to the use of teething tablets to the agency’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.