Health Journal Online

Tag: Approval

  • FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

    FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

    The US Food and Drug Administration (FDA) is warning consumers to avoid sunscreens sold in whipped, mousse, or foam forms, saying these products are not approved and could be unsafe.

    The agency recently sent warning letters to several companies, including Supergoop!, Vacation Inc., Kalani Sunwear, Botao Baby, and Tizo Skin, for marketing sunscreens in these unconventional formats.

    “These products might not be effective,” the FDA said in a post on X, emphasizing that whipped or mousse sunscreens have not been approved as safe or reliable for preventing sunburn or reducing skin cancer risk.

    The agency classifies these products as drugs because they are designed to protect against harmful UV rays, yet they have not received the necessary FDA approval.

    The FDA also raised concerns about packaging. According to FoxBusiness, many whipped and mousse sunscreens are sold in containers resembling food items, which could lead to accidental ingestion, especially by children.

    Vacation Inc., for instance, markets its “Classic Whip Sunscreens” as “dessert for your skin,” prompting the FDA to label the products as misbranded.

    “Packaging drug products in containers that resemble food containers commonly used by adults and children can mislead consumers into mistaking the products for food,” the agency warned.



    FDA Issues Warning on Supergoop! Mousse Sunscreen

    Supergoop! received a similar warning for its “Play SPF 50 Body Mousse.”

    The company told CBS MoneyWatch it is working to resolve what it described as a “product labeling” matter with the FDA and remains committed to maintaining high standards of safety and efficacy, NY Post said.

    Kalani Sunwear temporarily pulled its mousse-format sunscreen from its U.S. website to comply with regulations, while Botao Baby and Tizo Skin have not yet responded to inquiries.

    The FDA treats sunscreens like over-the-counter drugs, which means they have strict rules about how they can be sold.

    Right now, only lotions, creams, gels, oils, pastes, butters, ointments, and sticks are considered safe and effective.

    Sunscreens in mousse, foam, or whipped forms need separate FDA approval, and none of the ones on the market have it yet.

    Back in 2019, the FDA updated its sunscreen guidelines to reflect the latest science, including rules about active ingredients, SPF limits, broad-spectrum protection, and allowed forms.

    The Skin Cancer Foundation supports these rules, emphasizing that ongoing review is important as new UV filters and application methods come out.

    For now, consumers should read sunscreen labels carefully and steer clear of mousse, foam, or whipped products until they get FDA approval.

    Originally published on vcpost.com

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  • Journavx, New Type Of Non-Opioid Pain Relief Drug Gets FDA Approval

    Journavx, New Type Of Non-Opioid Pain Relief Drug Gets FDA Approval

    The U.S. Food and Drug Administration (FDA) has approved Suzetrigine, a new non-opioid pain relief drug sold under the brand name Journavx, to treat moderate to severe acute pain in adults.

    Journavx from Vertex Pharmaceuticals marks the first new class of pain reliever to receive FDA approval in over two decades. It will be sold as 50-milligram prescription pills that work by blocking pain signals at their source by targeting sodium channels in the nervous system and stopping pain before it reaches the brain.

    “Today’s approval is an important public health milestone in acute pain management. A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research said in a news release.

    Non-opioid pain relief is a crucial step forward in addressing the ongoing opioid crisis. With over 80 million Americans requiring pain relief, around half are prescribed opioids. However, nearly 10% of those initially prescribed opioids end up using them long-term, and about 85,000 develop opioid use disorder each year. Non-opioid alternatives offer a safer option for pain management, reducing the risk of dependency.

    According to the manufacturer, Journavx is a well-tolerated, effective pain reliever with no signs of addictive potential, designed for all types of moderate to severe acute pain.

    The efficacy of the drug was tested in two clinical trials involving surgical pain, one after tummy tuck surgery (abdominoplasty) and the other after bunion surgery. Participants were randomly given either Journavx or a placebo. If pain control was not enough, they could also take ibuprofen for extra relief. Both trials showed that Journavx worked significantly better than a placebo in reducing pain.

    The safety of Journavx was evaluated based on data from two main trials with 874 participants who had moderate to severe acute pain after a tummy tuck or bunion surgery, along with additional data from a smaller study with 256 participants in various acute pain conditions.

    The most common side effects reported were itching, muscle spasms, elevated creatine phosphokinase levels, and rash. Journavx should not be taken with strong CYP3A inhibitors, and patients should avoid grapefruit or grapefruit-containing foods and drinks while using it. The drug will be priced at $15.50 per 50mg pill.

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