FDA Reduces Recommended Salt Levels in Americans’ Food

Robin Foster, Robert Preidt and Steven Reinberg wrote . . . . . . . . .

The U.S. Food and Drug Administration announced Wednesday that it is lowering the recommended levels of sodium in processed, packaged and prepared foods.

The goal of the new, voluntary guideline is to help reduce Americans’ average sodium intake from 3,400 milligrams (mg) to 3,000 mg per day — roughly a 12% reduction — over the next 2.5 years.

“It’s really a pivotal day for the health of our nation as the FDA is announcing a critical step in our efforts to reduce the burden of diet-related chronic disease and advance health equity,” acting FDA Commissioner Dr. Janet Woodcock said during a media briefing announcing the new guideline.

“We as a nation face a growing epidemic of diet-related chronic diseases such as cardiovascular disease, obesity and diabetes, which disproportionately impact racial and ethnic minority groups,” Woodcock added.

“As a result, thousands of lives are lost and billions of dollars spent in health care costs each year for these preventable illnesses. We also know that limiting certain nutrients such as sodium in our diet can play a huge role in helping to prevent diseases such as hypertension [high blood pressure], cardiovascular disease and renal [kidney] disease,” Woodcock said.

U.S. Health and Human Services Secretary Xavier Becerra said the new guideline, although not mandatory, should help all Americans become more healthy.

“These new recommendations and target by the FDA take this a step closer to improving health outcomes for all Americans,” he said during the media briefing. “It keeps Americans on track to stay healthier as we move forward. [The] human and economic costs [of] diet-related diseases are staggering. And hundreds of thousands of Americans are learning that the hard way, as they contract these chronic diseases, and they face the consequences of poor nutrition. So, it’s time for us to do much better.”

Despite the lowering of recommended sodium levels in processed and packaged products, it still does not meet U.S. Dietary Guidelines for Americans’ recommended limit of 2,300 mg per day for those aged 14 and older, the FDA noted. Roughly 70% of added sodium in American diets comes from packaged, processed and restaurant foods, the agency noted.

The American Heart Association (AHA) applauded the FDA’s move, but said the agency needs to go further in the future.

“These targets will be an important driver to reduce sodium consumption, which can have significant health benefits and lead to lower medical costs,” the association said in a statement. “Lowering sodium levels in the food supply would reduce risk of hypertension, heart disease, stroke, heart attack and death in addition to saving billions of dollars in health care costs over the next decade. Many members of the food and restaurant industry have begun to reduce sodium in their products. We strongly encourage the industry as a whole to adopt these targets and build upon existing efforts to reduce sodium in their products and meals.”

Still, “lowering sodium intake to 3,000 mg per day is not enough. Lowering sodium further — to 2,300 mg — could prevent an estimated 450,000 cases of cardiovascular disease, gain 2 million quality-adjusted life years and save approximately $40 billion in health care costs over a 20-year period,” the AHA said.

“We urge the FDA to follow today’s action with additional targets to further lower the amount of sodium in the food supply and help people in America attain an appropriate sodium intake,” the association stated.

One nutritionist concurred.

“It is a first step, but we need to take a stronger stance,” said Sharon Zarabi, a registered dietician and program director for Northwell Health’s Katz Institute for Women’s Health in New York City and Westchester, N.Y.

“Most people believe they eat a low-sodium diet because they avoid use of the salt shaker. Little do they know that most of the sodium is lurking in every packaged food we consume. It serves as a flavor enhancer and preservative to increase shelf life. The effects are multifold, impacting our blood pressure, increasing our risk for cardiovascular disease, stroke, cancer, and increasing inflammation. Ever wonder why you feel so swollen after Chinese takeout or a bag of popcorn?” Zarabi said.

The FDA’s new guidance covers 163 categories of processed, packaged and prepared foods.

Woodcock pointed out that “research shows that people consume 50% more sodium than recommended. This includes our youngest and most vulnerable populations, with more than 95% of children aged 2 to 13 years old exceeding recommended limits of sodium for their age groups.”

She noted in an FDA news release: “A number of companies in the food industry have already made changes to sodium content in their products, which is encouraging, but additional support across all types of foods to help consumers meet recommended sodium limits is needed.”

Source: HealthDay

To Improve Nutrition and Reduce the Burden of Disease, FDA Issues Food Industry Guidance for Voluntarily Reducing Sodium in Processed and Packaged Foods

Statement From:

Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs – Food and Drug Administration

Susan T. Mayne, Ph.D.
Director – Center for Food Safety and Applied Nutrition (CFSAN)


A cornerstone of the U.S. Food and Drug Administration’s public health mission is to reduce the burden of chronic disease through improved nutrition. As a nation, we are facing a growing epidemic of preventable, diet-related conditions like cardiovascular disease, diabetes and obesity, and the agency’s work in this area has become even more urgent. For these reasons, we’re taking a critical step to further address preventable diet-related chronic diseases and advance health equity that we hope will become one of the most significant public health nutrition interventions in a generation.

Limiting certain nutrients, such as sodium, in our diets plays a crucial role in preventing diseases like hypertension and cardiovascular disease that disproportionately impact racial and ethnic minority groups; these diseases often result in hundreds of thousands of lives lost and billions in annual health care costs. The ongoing COVID-19 pandemic has only amplified these health disparities and the need for improved nutrition, as people with cardiovascular disease and other underlying conditions are at increased risk for severe outcomes from COVID-19.

For these reasons, we’re taking a critical step to further address preventable diet-related chronic diseases and advance health equity that we hope will become one of the most significant public health nutrition interventions in a generation.

Today, the FDA is issuing a final guidance, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,” which provides voluntary short-term sodium reduction targets for food manufacturers, chain restaurants and food service operators for 163 categories of processed, packaged and prepared foods. The guidance is another step the agency is taking to advance the Administration’s whole-of-government approach to nutrition and health and improve future health outcomes.

By limiting certain nutrients like sodium in our diets, we can help prevent diseases like hypertension and cardiovascular disease that disproportionately impact racial and ethnic minority groups, often resulting in hundreds of thousands of lives lost and billions in annual health care costs. The ongoing COVID-19 pandemic has only amplified these health disparities and the need for improved nutrition, as people with cardiovascular disease and other underlying conditions are at increased risk for severe outcomes from COVID-19.

Research shows that people consume 50% more sodium than recommended. This includes our youngest and most vulnerable populations, with more than 95% of children aged 2 to 13 years old exceeding recommended limits of sodium for their age groups. Although many consumers may want to reduce their sodium intake, about 70% of the sodium we eat comes from packaged, processed and restaurant foods, making it challenging to limit sodium. Changes across the overall food supply will make it easier to access lower-sodium options and reduce intake even in the absence of behavior change.

The targets in the final guidance seek to decrease average sodium intake from approximately 3,400 milligrams (mg) to 3,000 mg per day, about a 12% reduction, over the next 2.5 years. Although the average intake would still be above the Dietary Guidelines for Americans’ recommended limit of 2,300 mg per day for those 14 and older, we know that even these modest reductions made slowly over the next few years will substantially decrease diet-related diseases.

The final guidance outlines short-term goals that we’re recommending the food industry work to meet as soon as possible to help optimize public health. We will continue our discussions with the food industry as we monitor the sodium content of the food supply to evaluate progress. In the future, we plan to issue revised, subsequent targets to further lower the sodium content incrementally and continue to help reduce sodium intake. This iterative approach will help support gradual reductions in sodium levels broadly across the food supply so that consumers’ tastes adjust, health outcomes improve and no one company or category of food is singled out or scrutinized. Voluntary and gradual approaches such as this have also been successful in other countries, such as Canada and the U.K.

We first proposed recommendations for reducing sodium content in a 2016 draft guidance. A number of companies in the food industry have already made changes to sodium content in their products, which is encouraging, but additional support across all types of foods to help consumers meet recommended sodium limits is needed. Today, consumers can take steps to lower their sodium intake by reading food labels, including the Nutrition Facts label, asking for nutrition information at chain restaurants, choosing lower sodium options and speaking with their health care providers about eating healthier foods.

The FDA is committed to playing its part with the tools available to us to help create a healthier food supply, promote healthy habits early and empower consumers to make healthier food choices. We have already taken steps through our Closer to Zero action plan for reducing exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels and have more work ahead using a similar iterative process. Many of our federal, state and local partners also have initiatives underway that support sodium reduction and help people achieve healthier eating patterns overall. If we act together, we can have a profound impact on the health of millions of people.

Source: FDA

U.S. FDA Clamping Down on Abuse of an OTC Decongestant

Robert Preidt wrote . . . . . . . . .

Makers of inhalers that contain the nasal decongestant propylhexedrine should make design changes to prevent misuse, the U.S. Food and Drug Administration says.

Propylhexedrine is a nasal decongestant in over-the-counter inhalers, and right now is “only marketed under the brand name Benzedrex,” the FDA said. The agency said that propylhexedrine is effective and safe when used for short periods as directed for relief of congestion due to colds, hay fever or other upper respiratory allergies. But misuse can bring dangers.

“Benzedrex inhalers can be legally purchased, but propylhexedrine abuse occurs as people try to find legal ways to get high or increase productivity and concentration,” according to the National Capital Poison Center (NCPC).

“There have been many reports of toxicity associated with propylhexedrine extracted from an inhaler and swallowed or injected. Swallowing the contents of one propylhexedrine inhaler has caused heart attack and lung injury in adults and children,” the NCPC added.

The FDA warns that reports of abuse and misuse of propylhexedrine have been on the rise. The drug can lead to serious problems — including fast or abnormal heart rhythm, high blood pressure and paranoia — that can result in hospitalization, disability or death.

“We are requesting that all manufacturers of [over-the-counter] propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use,” the FDA said in a news release.

“For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult,” the agency said.

Reducing the amount of propylhexedrine in inhalers could also lower the risk of serious side effects, the FDA noted.

“We continue to evaluate this safety issue and will determine if additional FDA actions are needed,” the agency said.

Propylhexedrine was developed over 60 years ago as a substitute for amphetamine, once the active ingredient in Benzedrex inhalers, according to the NCPC. The center noted that the change was made in response to abuse and deaths from amphetamine extracted from the inhalers.

Propylhexedrine reduces swelling and inflammation of the nasal lining. The recommended dose for adults and kids over 6 is two puffs in each nostril, not more often than every two hours. It shouldn’t be used for more than three days at a time.

Prolonged use may cause congestion to recur or worsen.

The FDA urged people in the U.S. to call 911 or poison control at 800-222-1222 if someone using propylhexedrine experiences severe anxiety or agitation, confusion, hallucinations or paranoia, rapid heartbeat or abnormal heart rhythm, chest pain or tightness.

If you have questions about the drug, including how to use it or whether it may interact with another medicine you take, talk to a pharmacist or your health care provider, the FDA urged.

Source: HealthDay

FDA Warns of Dangers of Common Painkillers During Pregnancy

If you’re pregnant and you think popping nonsteroidal anti-inflammatory drugs (NSAIDs) for your aches and pains is safe, think again.

The U.S. Food and Drug Administration warned on Thursday that taking these widely used painkillers — which include Advil, Motrin, Aleve and Celebrex — at 20 weeks or later in a pregnancy could raise the risk of complications.

Specifically, taking the medications can cause rare but serious kidney problems in the unborn baby that can lead to low levels of amniotic fluid, increasing the potential for pregnancy complications.

After about 20 weeks of pregnancy, the fetus’s kidneys begin producing most of the amniotic fluid, so kidney problems can cause low levels of this protective fluid. Low levels of amniotic fluid usually resolve if a pregnant woman stops taking an NSAID, according to the FDA.

The agency said it has ordered that NSAID labeling warns women and their health care providers about this risk.

NSAIDs are prescription and over-the-counter (OTC) drugs that include ibuprofen, naproxen, diclofenac and celecoxib, which are taken to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules don’t apply to the use of low-dose aspirin.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Dr. Patrizia Cavazzoni, acting director of FDA’s Center for Drug Evaluation and Research, said in an agency news release.

One ob-gyn noted that over-the-counter NSAIDs may pose the greatest danger to pregnant women.

“Many female patients use ibuprofen regularly for headaches and menstrual cramps,” said Dr. Jennifer Wu, from Lenox Hill Hospital in New York City. “It is very important that these patients realize that ibuprofen and other NSAIDs pose a unique danger to pregnant patients.

“The majority of patients get these medications over the counter and may even be using them at the prescription-strength level,” Wu added. “While many prescription drugs come with the oversight of the pharmacist and a warning label, the over-the-counter medications lack all this. Patients also often assume that over-the-counter necessarily means safe.”

The FDA’s warning comes after a review of medical literature and cases reported to the agency about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy.

For prescription NSAIDs, the new FDA warning recommends limiting use between about 20 weeks to 30 weeks of pregnancy. A warning to avoid taking NSAIDs after about 30 weeks of pregnancy was already included in prescribing information due to a risk of heart problems in unborn babies.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest possible dose and shortest possible length of time, the FDA said.

Makers of OTC NSAIDs intended for adults will also make similar updates to their labeling, according to the agency.

Source: HealthDay

FDA Pulls Heartburn Drug Zantac From Market

All versions of the heartburn drug Zantac (ranitidine) have been pulled from the U.S. market due to possible contamination with a probable cancer-causing chemical, the U.S. Food and Drug Administration said Wednesday.

This is the latest step in an ongoing investigation of N-Nitrosodimethylamine (NDMA) in ranitidine medications, the agency noted.

In some ranitidine products, NDMA increases over time and when the drugs are stored at higher temperatures, which may result in people being exposed to unacceptable levels of the chemical, according to the FDA.

The agency’s order for immediate withdrawal of all ranitidine products means they won’t be available either by prescription or over-the-counter (OTC) in the United States.

“Today’s action requesting companies to withdraw all remaining ranitidine products the U.S. market is being taken out of an abundance of caution,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news briefing on Wednesday.

“Even though these products when they come off the factory line don’t contain unacceptable levels of (NDMA), we don’t know if they’re stored under various conditions what will end up at the end of the day,” she explained.

According to Woodcock, storage temperature appears to be key to the accumulation of NDMA in ranitidine.

“With ranitidine, the NDMA does not appear to be formed during manufacturing, but instead appears over time in storage, especially when stored at higher than room temperature,” she said. Packaging or specific formulations of the drug might play a role, too.

All of that means that the buildup of NDMA in stored Zantac “may be a fixable problem,” she told reporters. “We’re open to companies demonstrating that they’ve reformulated their product in a way that is stable.”

But for now, consumers taking OTC ranitidine should stop taking any tablets or liquid they have, dispose of them properly and not buy more. Those who want to continue treating their condition should consider using other approved OTC products, the FDA recommended.

Patients taking prescription ranitidine should talk with their health care provider about other treatment options before they stop taking the medicine, the FDA said. There are multiple drugs approved for the same or similar uses as ranitidine that don’t have risks from NDMA.

FDA tests have not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Due to the current coronavirus pandemic, people shouldn’t take their ranitidine medications to a drug take-back location, the FDA noted. Follow the disposal instructions in the medication guide or package insert, or follow the FDA’s recommendations on how to safely dispose of the medications at home, the agency said.

NDMA is an environmental contaminant that can be found in water and foods and has been classified as a “probable human carcinogen” by the World Health Organization.

The presence of NDMA in minute quantities has already led to the recall of many types of blood pressure medications, such as valsartan and losartan.

NDMA’s potential presence in Zantac and generic versions of ranitidine was first reported in September 2019.

Source: HealthDay


Today’s Comic