The FDA’s New EPA/DHA Health Claim

Jessica Levings wrote . . . . . . . . .

Fish and seafood packaging may now boast qualified health claims stating that omega-3s can help reduce risk of hypertension and coronary heart disease and lower blood pressure.

In June, the FDA approved the use of certain qualified health claims on foods and dietary supplements containing the omega-3 fatty acids EPA and DHA relating to their ability to reduce the risk of hypertension and coronary heart disease, as well as lower blood pressure. The decision was in response to a 2014 petition submitted by the Global Organization for EPA and DHA Omega-3 (GOED).

According to Harry Rice, PhD, GOED’s vice president of regulatory and scientific affairs, who spearheaded the health claim petition on behalf of the organization and its members, “The new qualified health claims provide what many, including GOED, consider to be long overdue acknowledgement from the FDA about the blood pressure–lowering benefits associated with EPA/DHA, the primary long-chain omega-3 fatty acids found in fatty fish. Linking EPA/DHA intake to blood pressure reduction provides consumers a benefit to which they can relate.”

Before the announcement of the new qualified health claims, since 2004 the FDA has allowed the following qualified health claim on certain foods and supplements: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

Following are the new qualified health claims the FDA announced, which manufacturers may voluntarily use on labels of seafood and other qualifying foods and supplements:

1. Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

2. Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

3a. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

3b. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

4. Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

Dietary supplements and conventional foods bearing any of the above claims must contain at least 0.8 g EPA and DHA (combined total) per serving and meet certain other nutrient content criteria. Importantly, the requirement of 0.8 g per serving isn’t a recommended intake level but rather a level of intake the FDA observed to lower blood pressure in limited studies.

Under general health claim requirements, individual foods can’t bear a health claim if they exceed 13 g total fat, 4 g saturated fat, 60 mg cholesterol, and 480 mg sodium per reference amount customarily consumed (RACC), per labeled serving size, and per 50 g if the RACC is 30 g or less or two tablespoons or less. Furthermore, to bear a health claim, individual foods also must contain, before any nutrient addition, at least 10% DV for vitamin A, vitamin C, iron, calcium, protein (5 g), or dietary fiber per RACC.

Evidence Base for the EPA/DHA Health Claim

The FDA determined that the overall evidence relating to EPA/DHA intake and blood pressure didn’t meet the “significant scientific agreement” standard required for an authorized health claim, but it did meet the “credible evidence” standard for a qualified health claim.

To assess whether a beneficial link exists between consuming EPA and DHA together and lowering blood pressure, the FDA evaluated 104 intervention studies analyzing the effect of EPA and DHA from conventional foods, dietary supplements, and prescription drugs on blood pressure in both normotensive and hypertensive people. Only 36 of the 104 studies showed a statistically significant benefit, with durations ranging from four weeks to one year, and combined doses of EPA and DHA ranging from 390 mg per day to 15 g per day.

Based on its findings, the FDA concluded there’s “some credible evidence suggesting a relationship between the combined intake of EPA and DHA from conventional foods, dietary supplements, and prescription drugs and blood pressure reduction. However, this evidence is highly inconsistent.”

Sources of EPA and DHA, Average Intake

EPA and DHA are added to certain supplements and are naturally found or fortified in some conventional foods, including fatty fish (eg, salmon, mackerel, sardines), fish oils, seaweed, and algal oils. Studies have found that food contributes a small amount of DHA and EPA to total daily omega-3 intakes; the National Institutes of Health estimates the amounts at 40 mg in children and teenagers and about 90 mg in adults.

Dietary supplements containing omega-3s also contribute to total omega-3 intake, with fish oil as one of the most commonly used sources. According to 2012 data, 7.8% of US adults and 1.1% of US children reported taking supplements containing fish oil, omega-3s, and/or DHA or EPA. According to 2003–2008 National Health and Nutrition Examination Survey (NHANES) data, supplements add about 10 mg to average DHA intakes, and 20 mg to average EPA intakes in adults. Data from the FDA and NHANES indicate that the current average intake of EPA and DHA in the United States is only about 77 mg per day from all sources for people aged 4 and older.

Currently, there’s no recommended intake level in the United States for EPA or DHA. However, to help improve heart health, the 2015–2020 Dietary Guidelines for Americans (DGA) recommend individuals in the general population to consume about 8 oz per week of a variety of seafood, providing about 250 mg per day of EPA and DHA. Importantly, the DGA note that this recommendation is for the total package of nutrients seafood provides, including its EPA and DHA content.

Use of the EPA/DHA Health Claim on Fish

For items sold at seafood counters in supermarkets, nutrition labeling of fresh fish and packaged single-ingredient fish is voluntary unless nutrient content or a health claim is made. Fish and packaged seafood may bear the claim if they meet all the required criteria for its use.

The FDA defines fish as “fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin, and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.” With regard for labeling these products with the EPA/DHA qualified health claims, the FDA considers “products that are essentially all fish” to be those without any added ingredients and with an “insignificant amount” of added fat or carbohydrate. Examples of products considered all fish include raw, boiled, and broiled fish.

Source: Today’s Dietitian

Heartburn Drug May Contain Small Amounts of Known Carcinogen, FDA Says

A substance that could cause cancer has been found in some ranitidine heartburn and ulcer medicines, including the brand-name drug Zantac, and the source of this contamination is being investigated, the U.S. Food and Drug Administration says.

While preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said this does not mean patients taking the drugs should stop using them now.

NDMA is the same contaminant found in many brands of blood pressure and heart failure medicines during the past year, leading to recalls.

Patients who are taking prescription ranitidine and want to stop using it should discuss alternatives with their health care provider, the FDA advised. Those taking over-the-counter (OTC) ranitidine could switch to other OTC medicines.

Several drugs are approved for the same or similar uses, the FDA noted.

NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. It is classified as a probable human carcinogen.

“Drug impurities remain a major national concern,” said Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City. “While Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple: switch to another drug … and of course, confirm with your doctor the need for an antacid.”

The FDA said it’s evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it’s available.

In a statement, pharmaceutical giant Sanofi, which makes Zantac, said that it “takes patient safety seriously, and we are committed to working with the FDA. Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”

In the meantime, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the FDA is working with international regulators and industry partners to find out where the contamination originated.

“The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients,” she said in a news release. “The FDA will take appropriate measures based on the results of the ongoing investigation.”

Large amounts of NDMA may pose a risk, but the levels of NDMA in ranitidine found in preliminary tests barely exceed amounts found in common foods, according to the FDA.

Ranitidine decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn, and prescription ranitidine is approved for a number of uses, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease.

Similar contamination in heart medicines is also under investigation.

“The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year,” Woodcock said. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Source: HealthDay


Today’s Comic

U.S. FDA Revealed Tests Results for Per- and Polyfluoroalkyl Substances (PFAS) in Food

Nicole Javorsky wrote . . . . . . . . .

These chemicals take millennia to break down and have negative health consequences, and the FDA revealed they exist throughout the US food supply. Concerns about per- and polyfluoroalkyl substances (PFAS), have typically been associated more with water than food. But when the FDA decided to look at the food supply, they found considerable levels of these “forever chemicals” in certain seafood, off-the-shelf chocolate cake, and some grocery store meats.

As Jamie C. DeWitt, a toxicologist who researches PFAS at East Carolina University, told Mother Jones, the FDA finding “tells us that drinking water is not our only source of exposure.”

According to the FDA, almost 5,000 types of PFAS exist. First developed in the 1940’s, they were seen as remarkably versatile since they do not allow grease, water, or oil to penetrate any material that had been treated by them. As a result, PFAS can be found in a broad range of products from stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, in addition to “limited, authorized uses” in cookware and food packaging.

Over time, however, it was discovered that exposure to PFAS chemicals can increase the risk of cancer, increase cholesterol levels, affect the immune system, and interfere with the body’s hormones, according to the Agency for Toxic Substances and Disease Registry.

Right now, the Environmental Protection Agency drinking water advisory for PFAS remains the only guideline the federal government has set for PFAS chemicals. By the end of this year, the EPA will propose a long-awaited regulation on PFAS. The FDA established an internal agency PFAS workgroup to establish base-line levels for PFAS in foods.

The FDA has expanded their testing over the past year to analyze PFAS levels in foods “typically eaten by Americans” and not sampled from specific contamination areas. The agency said this is the first time they’ve “tested for PFAS in such a highly diverse sample of foods.”

In their recent press announcement, the FDA said they believed the PFAS contamination found in 14 samples out of 91 were “not likely to be [a] health concern.” Meanwhile, their testing revealed “forever chemical” levels surpassing 70 parts per trillion (the existing federal recommendation for PFAS in drinking water) in samples of turkey, tilapia, baked cod, salmon, steak, lamb chop, shrimp, chicken thighs, and catfish. The chocolate cake had levels over 250 times that of federal guidelines.

Federal agencies such as the EPA, have been slow to regulate chemicals, especially under the Trump administration, but there has been a recent bipartisan push in Congress to address PFAS, for example by banning new uses or development of PFAS chemicals, with at least 20 bills introduced this session, according to The Hill.

“These compounds are in the environment. We know that they build up in our bodies. They produce adverse health outcomes,” said DeWitt. “I think it’s time to make a decision so that people can be protected.”

Source: Mother Jones


Read also at FDA:

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys . . . . .


Today’s Comic

FDA Strengthens Sunscreen Rules

The U.S. Food and Drug Administration took steps to tighten regulation of over-the-counter sunscreen products.

Included in the proposed rule are updates on sunscreen safety, sun protection factor (SPF) requirements, and the effectiveness of insect repellent/sunscreen combinations.

“The proposed rule that we issued today would update regulatory requirements for most sunscreen products in the United States, to better ensure consumers have access to safe and effective sun care options in line with the latest science,” FDA Commissioner Dr. Scott Gottlieb said during a media briefing Thursday morning.

The proposal “applies only to sunscreen active ingredients currently on the market in the United States without FDA-approved application. And that’s actually the vast majority of sunscreens available in the United States,” added Dr. Theresa Michele, director of the division of nonprescription drug products at the FDA’s Center for Drug Evaluation and Research (CDER).

Under the proposed rule, two of the 16 active ingredients in sunscreens — zinc oxide and titanium dioxide — are now considered safe and effective, while two others (PABA and trolamine salicylate) are not. No sunscreens sold in the United States contain PABA or trolamine salicylate.

Safety data for 12 other sunscreen ingredients is not sufficient to determine if they are safe and effective, the agency added.

“Therefore,” said Dr. Janet Woodcock, director of the CDER, “we are asking for additional clinical and non-clinical data on these 12 ingredients.”

The Environmental Working Group (EWG), a watchdog organization for consumer health, called the new initiative way overdue.

“After more than 40 years, the FDA is at last taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective,” David Andrews, senior scientist at EWG, said in a news release.

He pointed to one ingredient, oxybenzone, in particular.

“For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption,” Andrews said. “Today the FDA recognized those concerns.”

Woodcock noted that labeling changes will also make it easier for consumers to understand what they are buying.

“Since 1999, new scientific evidence has helped to shape FDA’s perspective on what active ingredients could be considered safe and effective, among other things,” Woodcock said in a CDER statement.

“I want to emphasize that the proposed rule does not require any sunscreen products to be removed from the market at this time,” she added. “Manufacturers will be able to provide comment and submit data on the proposals contained in the proposed rule, including safety data for active ingredients for which insufficient data [now] exist.”

Types of sunscreen generally considered safe and effective include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.

Meanwhile, “we have found sunscreen powders eligible … but are requesting additional safety and efficacy data on powders before they can be included [in the proposed rule]. We are proposing to exclude wipes, towelettes, body washes, shampoos and other dosage forms,” Woodcock said.

Also, products that combine sunscreens with insect repellents are not generally considered safe and effective, the agency stated.

Under the rule, the maximum sun protection factor on sunscreen labels would be raised from SPF 50+ to SPF 60+.

“We are proposing to permit the marketing of sunscreen products formulated with SPF values up to 80, but not above, unless the product has an approved [new drug application],” Woodcock explained.

Sunscreens with SPF values of 15 and higher will be required to be broad spectrum, and broad spectrum protection against UVA radiation must also increase as SPF increases, the rule states.

“This will ensure that these products provide consumers with the protections they expect against skin cancer and early skin aging,” Woodcock said.

New sunscreen label requirements will include listing of active ingredients on the front of the bottle and other requirements for the front of sunscreen bottles — all meant to help consumers better understand what the sunscreens they are buying can actually do.

Source: HealthDay


Today’s Comic

FDA Takes Action Against 17 Companies for Illegally Selling Products Claiming to Treat Alzheimer’s Disease

The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions. These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.

“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”

In a statement issued today, FDA Commissioner Gottlieb also outlined several important new actions and policy priorities the agency will take in the coming months to improve the safety of dietary supplements and purported dietary supplements, including efforts to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety and other, new steps the FDA could consider taking to better ensure product safety and integrity.

The products cited in the warning and online advisory letters posted today are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions, and have been sold in violation of the Federal Food, Drug, and Cosmetic Act. The products include a variety of product types, such as tablets, capsules and oils. The companies have been asked to respond to the FDA within 15 days of receipt of the letters, stating how the violations outlined in the agency’s letters will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

As part of the FDA’s effort to protect consumers from Alzheimer’s disease health fraud, the FDA has issued more than 40 warning letters in the past five years to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media and in stores. We’ve also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions such as cancer and opioid addiction. Although these companies may have stopped selling the products or making unproven claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites.

The FDA continues to encourage consumers to remain vigilant whether online or in a store in order to avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work. Health care professionals and consumers are also advised to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: U.S. Department of Health and Human Services