Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning
Vita Warehouse Corp., based in New York, issued a voluntary recall for more than 40,000 bottles of Vitamin B12 supplements on June 12 because of the possible undeclared presence of peanut, a major food allergen. The FDA subsequently issued is Class I risk classification on July 3.
Newsweek contacted Vita Warehouse Corp. for comment by email outside regular working hours.
A Class I risk classification represents "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the FDA.
Peanuts are one of the nine major food allergens as set out in law. The others are eggs, milk, fish, crustacean shellfish, tree nuts, wheat, sesame and soybeans.
The FDA warned that people who have an allergy or severe sensitivity to peanuts "run the risk of serious or life-threatening allergic reactions if they consume these products."
Allergic reactions vary in severity from mild symptoms such as hives and lip swelling to life-threatening complications such as anaphylaxis that may include fatal respiratory problems.
The products impacted by the recall include:
Welby Vitamin B12 Energy Support 1000 mcg 140 gummies - UPC Code: 4099100290868 - lot number: 248046601 - expiration date: 10/2026Berkley Jensen Vitamin B12 1000 mcg 250 gummies - UPC Code: 888670132487 - lot number: 248046601 - expiration date: 10/2026VitaGlobe Vitamin B12 Extra Strength 60 gummies - UPC Code: 850005214670 - lot number: 248046601 - expiration date: 10/2026
The products were distributed nationwide at Aldi and Berkley Jensen stores, and online.
As of June 13, no illnesses or allergic reactions had been reported in connection with the products.
The recall was initiated after Aldi conducted routine testing that indicated a "potential presence of a peanut allergen," according to the FDA.
"Although internal testing conducted by Vita Warehouse Corp. has verified the absence of peanuts in the product, the recall is being initiated out of an abundance of caution to ensure consumer safety and trust," the recall notice said.
The FDA, on its website: "People with food allergies should read labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food."
Dr. Sebastian Lighvani, director of New York Allergy & Asthma PLLC, previously told Newsweek: "Every three minutes in the United States, someone ends up in an emergency room because of an allergic reaction after accidental ingestion of food. So even when we try hard, these reactions are happening. And if you look at the incidence of anaphylaxis, it has skyrocketed in the last five, 10, 20 years. And in the U.S., there's like a 300 to 400 percent increase in the rates of anaphylaxis to foods."
The recall is listed as ongoing, according to the FDA.
Consumers who are allergic to peanuts and may have purchased the affected products are advised to return them to their place of purchase for a full refund or discard them immediately. Consumers who experience allergic reactions should seek medical attention immediately.
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The Hill
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Credit - Photo-Illustration by TIME (Source Images: Liudmila Chernetska—Getty Images, LanaSweet/Getty Images) Federal health officials are scrutinizing a mineral—added to some makeup, medications, and foods—that many people have never thought twice about: talc. In a recent viewpoint article called 'Priorities for a New FDA,' published in the medical journal JAMA, Dr. Martin Makary, commissioner of the U.S. Food and Drug Administration (FDA), and Dr. Vinay Prasad, the FDA's Chief Medical and Scientific Officer, wrote that the FDA conducted an expert panel on talc in May. They also noted that some companies have removed talc from baby powder because it's a carcinogen. Johnson & Johnson, for example, stopped using talc in 2023 following more than 60,000 legal claims from ovarian cancer patients. The JAMA article added that talc remains common, since people still 'ingest it regularly' as an ingredient in various medications and foods. Despite the lawsuits, though, research hasn't confirmed whether talc causes cancer, especially when consumed through food. Meanwhile, companies continue to use talc in powders and cosmetics. Here's how people get exposed to talc, the potential health risks, and what to do about them. Talc and asbestos A naturally occurring mineral, talc consists of several elements like magnesium and silicon. When ground into fine particles, talc becomes talcum powder, which works to absorb moisture and soothe the skin. People have used cosmetics and powders with talc for more than a century. Before talc is mined by companies from deep within the earth, it mixes with another mineral, asbestos. This often results in talc's contamination with asbestos, which is proven to cause cancer. Talc, when laced with asbestos, is a carcinogen, especially when it's inhaled. Less clear is the cancer-causing potential of talc when it's not contaminated. In theory, talc on its own could drive cancer because its particles create inflammation when inhaled or migrating into the body after talc is applied to skin, according to Joellen Schildkraut, professor of epidemiology at Emory University. 'Inflammation can promote cancer,' Schildkraut says. 'Many studies have shown an association.' Some research shows that asbestos-free talc leads to tumors in animals, but animals reveal little about ovarian cancer in humans, Schildkraut says. Read More: The Race to Explain Why More Young Adults Are Getting Cancer Regardless, it's impossible for consumers to learn if products with talc are contaminated. Since the 1970s, companies have tested talc voluntarily, but the methods aren't sensitive enough to detect asbestos in their products—and the FDA doesn't require proof that they're asbestos-free. 'This means a lot of contaminated talc likely went through without anybody detecting the asbestos,' Schildkraut says. Using better tests, researchers have spot-checked whether cosmetics are asbestos-laced. From 1948 to 2017, two-thirds of these tests (conducted as part of litigation) came up positive for asbestos, typically in trace amounts. In 2020, the nonprofit Environmental Working Group found asbestos contaminated 15% of makeup samples with talc. In 2023, the FDA detected no asbestos in 50 talc-containing cosmetics. (The agency didn't reply to TIME's request for comment.) However, conclusions can't be drawn about the entire market from these checks because they involved small sample sizes, says Kaley Beins, a senior scientist at the Environmental Working Group. Later this year, the FDA is expected to finalize a new rule aimed at improving companies' testing methods. Ovarian cancer risk Some data show links between cancer of the ovaries and a specific type of talc exposure: the use of baby powder in intimate areas for personal hygiene. But the findings have been mixed. In a June letter to Makary, several talc researchers—some with ties to companies that make products with talc—criticized the recent FDA roundtable on talc's health impacts. The roundtable discussions, the authors wrote, were skewed because they 'included several paid plaintiff-side experts in talc-related litigation' without any defense-side experts. The letter says that studies involving several different groups of women have found only very weak associations with ovarian cancer. Schildkraut—an expert participant in the May roundtable without any ties to the lawsuits—notes that some of these studies involved relatively few women diagnosed with ovarian cancer. It's possible there simply wasn't enough data to yield stronger evidence. However, in 2020, scientists pooled together data from groups studied previously and still found no significant link. Read More: Scientists Are Finding Out Just How Toxic Your Stuff Is An important factor is that 'people may not be good at reporting their personal talc use,' says Katie O'Brien, a staff scientist at the National Institute of Environmental Health Studies and lead author of the 2020 research. In another study last year, she tried to correct for reporting errors while reanalyzing data from over 50,000 women and found that frequent users of talcum powder did have higher risk of ovarian cancer. 'This type of research doesn't determine causation,' says Schildkraut, who emphasized the same point during the public roundtable. 'But we do see a consistent relationship.' The self-report issue noted by O'Brien could extend to powder use for babies. 'People may not know whether baby powder was used on them,' O'Brien explains. Meanwhile, some laboratory research shows that human ovarian cancer cells, when exposed to talc, have more inflammation and cellular growth, mechanisms that can fuel cancer. Read More: Inflammation May Be the Culprit Behind Our Deadliest Diseases But Jennifer Permuth, an epidemiologist at the Moffitt Cancer Center who has served as an expert witness for J&J and signed the letter to Makary, questions how talc would migrate from where it's applied to cause cancer in the ovaries—without causing cancer in other organs along the way, such as the cervix. 'We would expect cancer to also develop in those other organs,' but studies find only weak links to these cancers, says Permuth. In a 2024 review, the World Health Organization found that, overall, evidence doesn't prove talc causes cancer, but it's 'probably carcinogenic.' The review focused on ovarian cancer 'because that's where the most evidence was' compared to other cancers, says Schildkraut, who served on the review committee. Meanwhile, the American Cancer Society states that, if there's an increased cancer risk, it's 'likely to be very small.' The E.U. has designated talc as a carcinogen, and it's expected to ban talc from cosmetics in 2027. Other potential health issues There's less research on other health issues related to talc. Some studies suggest that when miners repeatedly inhale talc, even if it's asbestos-free, their risk of lung cancer increases—but evidence on inhaling baby powder is more limited. In addition, a deadly cancer called mesothelioma is closely linked to asbestos exposure, though links to talc are less clear (partly because mesothelioma is extremely rare). Read More: What to Expect at a Mammogram Karen Selby, a patient advocate for the Mesothelioma Center at team of advocates, doctors, and attorneys supporting people with mesothelioma—works with patients who developed the disease decades after early-life exposure to cosmetics, she says. Every Christmas as a kid, Selby got a new box of cosmetic powder to play with. She'd cover herself and act like Casper the Friendly Ghost. She doesn't have mesothelioma, but recalling the haze of talc dust, she sometimes thinks, 'Holy cow, what was I doing to myself?' These makeup kits often have cheaper ingredients like asbestos-contaminated talc, despite that 'children are a susceptible group in environmental health,' says Beins, the Environmental Working Group scientist. 'I would try to keep talc away from them.' Safety precautions As researchers continue to study talc, Beins recommends using products with talc substitutes like cornstarch. (That's what J&J now uses instead of talc.) 'We can acknowledge the uncertainty and use safer alternatives,' Beins says. The Environmental Working Group has a database called Skin Deep that tracks which cosmetics contain ingredients like talc. Currently, the database lists about 150,000 products, and 8,000 have talc, Beins estimates. 'I wouldn't use talc personally,' Schildkraut says. 'It's not worth the risk because you don't need much exposure to asbestos to develop cancer.' Read More: 6 Things to Eat to Reduce Your Cancer Risk If possible, try passing on baby powders in general. Even if they lack talc, 'there may be other chemicals of concern,' such as ones added for fragrance or texture, O'Brien notes. If you've been exposed to talc for decades—whether through personal product use or occupations that often involve talc, like those in hair care—share this information with your doctors. They may recommend screening for ovarian cancer and other conditions, O'Brien says. What about food and medicine? Talc is commonly added to several foods like chewing gum and candy to keep them from sticking to wrappers and caking together. However, relatively few foods have talc. 'It's there and present sometimes, but it's not in a ton of food,' Beins says. To find which foods contain talc, you can search EWG's Food Scores, which tracks ingredients. Out of 80,000 products in the database, only 39 are currently listed to contain talc. In addition, the Environmental Working Group's Verified program certifies brands that meet its strictest health standards. To be certified, brands must disclose their ingredients, provide testing data, and avoid ingredients of concern. Products with talc can't be certified. Read More: Why Food Chemicals Are a Problem—And How to Reduce Your Exposure Talc is also added to some pill coatings because it helps pills travel smoothly through manufacturing equipment during production. But very little is known about cancer risk from talc in either food or pills. 'There's some thought that gastrointestinal issues might happen due to food exposure, because it's pro-inflammatory,' Beins says. However, this effect is mostly theoretical at this point. 'For the sake of public health, we shouldn't raise false alarms and make people scared of their food and medications,' says Permuth, who researches gastrointestinal cancer. 'Frequent users of talc-based personal care products or cosmetics are at the highest risk,' O'Brien says, adding that there's no medical reason for using these products. Whereas other established environmental risks like air pollution may be hard to avoid, O'Brien notes that for the most part, the 'use of talc products is something that individuals can control.' Contact us at letters@ Solve the daily Crossword
