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


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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

U.S. FDA Warns of Dangers of Liquid Nitrogen in Food, Drinks

You risk serious injury if you consume or handle food and drink products where liquid nitrogen is added just before consumption, the U.S. Food and Drug Administration warned Friday.

These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold.

Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and nonalcoholic drinks prepared with liquid nitrogen that emit a fog.

Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma, according to the agency.

“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served,” explained Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City.

“In liquid form, it can cause burns to the mouth, esophagus and upper airway, leading to perforation or rupture of the organs — which could be deadly,” Glatter said. “It may also cause burns of the fingers or hands when it is handled in the liquid state.”

And people with asthma or lung disease who inhale the vapors might experience constriction of their airways, triggering an asthma attack or worsening of their lung disease, he added.

“Beyond this, it may also lead to inflammation in the lungs and aspiration, which can reduce the ability to breathe, as well as trigger infections such as pneumonia,” Glatter said.

In fact, the FDA said it has received reports of severe and life-threatening injuries caused by liquid nitrogen in food and drinks, and also reports of breathing problems.

“With state fairs upon us, parents and teens need to understand the potential risks of foods such as nitro popcorn and nitrogen-infused cereals, which promise excitement and thrill but may end with a trip to the emergency department,” Glatter noted.

People who’ve suffered an injury after handling or consuming food or drinks prepared with liquid nitrogen should consult a health care provider, and also consider reporting their injury to MedWatch, the FDA’s safety reporting program, the agency said.

Source: HealthDay

U.S. Food and Drug Administration Warns Vaginal Rejuvenation Devices have Serious Side Effects

From press release of FDA . . . . . .

We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.

As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.

In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.

We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.

Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.

We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.

We’ve been focused on advancing new policies to improve our oversight of device safety. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women’s health, we’ve begun building out important device safety registries. We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with “vaginal rejuvenation” procedures. We will keep the public informed if significant new information becomes available. We’d also like to learn more about patients’ experiences with these procedures. We encourage those who’ve had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Source: U.S. Food and Drug Administration

FDA Warns Long-term Risks with Antibiotic Clarithromycin (Biaxin) in Heart Disease Patients

The antibiotic clarithromycin (brand name: Biaxin) may increase the long-term risk of heart problems and death in patients with heart disease, according to U.S. health officials.

As a result, the federal Food and Drug Administration said Thursday that it’s recommending that doctors carefully weigh the benefits and risks of the drug before prescribing it to patients with heart problems.

The agency said its warning is based on a 10-year follow-up study of patients with coronary heart disease. The study found an unexpected and unexplained increase in deaths among heart disease patients who took clarithromycin for two weeks and were followed for one year or longer.

There’s no clear explanation for how clarithromycin would increase heart disease patients’ risk of death, the FDA said in a news release.

One heart specialist said this type of alert is worth heeding, however.

“It is important for health professionals and pharmacists to identify potential interactions between medications and eliminate prescription errors to prevent this risk,” said Dr. Marcin Kowalski. He directs cardiac electrophysiology at Staten Island University Hospital in New York City.

The FDA said it has added a new warning about this increased risk for heart patients, and is advising doctors to consider prescribing other antibiotics to these patients. The agency added that it will continue to monitor safety reports in patients taking clarithromycin.

The antibiotic is used to treat many types of infections affecting the skin, ears, sinuses, lungs and other parts of the body.

Doctors should talk to their heart patients about the risks and benefits of clarithromycin and alternative treatments. If doctors prescribe clarithromycin to patients with heart disease, they should inform those patients about the signs and symptoms of cardiovascular problems, the FDA said.

And patients with heart disease should tell their doctor about their condition, especially when they are being prescribed an antibiotic to treat an infection.

Heart disease patients should not stop taking their heart disease medicine or antibiotic without first talking to their doctor, the FDA said.

Patients taking the antibiotic should seek immediate medical attention if they experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of the body, or slurred speech, the agency said.

Dr. Satjit Bhusri is a cardiologist at Lenox Hill Hospital in New York City.

He said, “Although this study suggests an association between this specific antibiotic, there have not been any direct correlations to increased heart disease.

“I would also extend this to all antibiotics in general. A short course of antibiotic therapy for a bacterial infection should be initiated if indicated by the physician; and a history of antibiotic therapy, at this time, should not be considered a risk factor for heart disease,” he said.

Source: HealthDay