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Vitamin D is an essential nutrient you mainly get from sun exposure. If you don’t get enough of it, some research suggests you could be at a higher risk of experiencing depression. However, research on whether supplementing with vitamin D can relieve depressive symptoms is mixed.
Vitamin D deficiency is common—affecting about 35% of adults in the United States—and is associated with several health problems.
For instance, lack of vitamin D is linked to cancer, cardiovascular disease, diabetes, multiple sclerosis, and autoimmune diseases. More recently, vitamin D has emerged as a possible cause of depression.
However, researchers have not determined definitively that vitamin D deficiency causes depression, though the two are linked. One large population-based study found an association between vitamin D status and depression in middle-aged adults.
The study results suggest that vitamin D deficiency and insufficiency may help identify adults who are at an increased risk of developing depression. Deficiency may also serve as a biomarker for people with depression whose symptoms persist despite treatment, meaning monitoring deficiency levels may help with depression diagnosis and tracking treatment progress.
Vitamin D supports several body functions and is essential for overall health. The vitamin helps your body absorb calcium and is an important component in developing strong bones and teeth.
Together, calcium and vitamin D help protect your body from developing osteoporosis. This condition causes your bones to weaken and become brittle, making them more likely to break. Low vitamin D also makes you more susceptible to osteomalacia, a condition causing bones to soften, leading to bone pain, muscle weakness, and bone deformities like rickets.
However, vitamin D’s role is not limited to bone health. It also has anti-inflammatory, antioxidant, and brain-protective properties and supports several other bodily functions.
For instance, having adequate amounts of vitamin D can boost your immune system’s ability to fight off viruses and other germs. Your muscles rely on vitamin D to move, and your nerves utilize vitamin D to send messages between your brain and your body.
Depression is a mood disorder that affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working.
People who have depression often experience one or more of the following symptoms nearly daily for at least two weeks:
Everyone who is depressed experiences this condition differently and will not have every symptom listed above. If you or someone you love is showing signs of depression, contact the Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-4357 for information on support and treatment facilities in your area.
Several small studies have found that people who are depressed experience improvements in their symptoms after they start taking vitamin D supplements.
However, other research shows that supplementing with vitamin D does not affect symptoms of depression. For example, a large study including more than 18,000 people with depression found that taking 2,000 international units (IU) daily of vitamin D for five years did not change depression scores compared with taking a placebo. Several other studies came to similar conclusions.
Vitamin D is not included in the guidelines for treating mood disorders. More research is needed to determine the effectiveness of vitamin D for depression, as well as what blood levels are needed and how to supplement when a person is depressed.
If you have depression and suspect that your vitamin D levels are low, the best thing you can do is to talk with a healthcare provider. They may order a blood test to determine your vitamin D status. This will give you a baseline measurement of your vitamin D levels before you begin supplementation.
If you cannot afford testing, you may be able to supplement without testing as long as you stay within the recommended daily intake of vitamin D, which is 600-800 IU for adults. Some health experts maintain that taking vitamin D without testing is safe, especially if you know you aren’t getting adequate sunlight or eating fortified foods.
Your exact vitamin D needs are based on your age, health status, and skin color; non-Hispanic Black Americans, women, and people 20-29 years old are particularly at risk for vitamin D deficiency.
When taking vitamin D, be aware of how much you consume and avoid taking too much. Because vitamin D is fat-soluble, it has the potential to build up in your system and can result in vitamin D toxicity.
People with vitamin D toxicity may develop kidney stones (mineral clusters in urine that are difficult and painful to pass through the urinary tract).
Other symptoms include:
Extremely high vitamin D levels may cause irregular heartbeat, kidney failure, and death.
Vitamin D toxicity is almost always caused by supplementation. You cannot get too much vitamin D from the sun. Your skin naturally limits the amount of vitamin D it makes from sunshine.
Research indicates that symptoms of vitamin D toxicity are most likely to occur when your daily intake is at least 10,000 IU. However, amounts less than the tolerable upper intake level of 4,000 IU could also have a negative impact over time.
Vitamin D supplements may interact with some medications, including diuretics, statins, steroids, and Orlistat (a weight-loss drug). Some of these medications can also increase your risk of vitamin D toxicity. Talk to a healthcare provider before taking vitamin D supplements if you are taking any other medications or supplements.
ORLANDO, Fla., Dec. 17, 2025 /PRNewswire/ — Swisse – a premier brand of the Certified B Corp , Health & Happiness (H&H) Group, and a global leader in premium, science-backed wellness supplements, is expanding its portfolio with Glam Bites — a groundbreaking new line that supports beauty from within and makes daily self-care effortless for today’s busy woman.
Swisse premium supplement brand introduces Glam Bites – delicious zero sugar beauty gummies made with ingredients backed by science without the junk. Pictured from left to right: Swisse Beauty Glow Skin, Hair Skin Nails and Skin Defense Glam Bites are all crafted with zero sugar, no sugar alcohols, no artificial flavors, colors or sweeteners and are free from gluten and major allergens.1 (1) Major allergens include milk, eggs, fish, crustacean shellfish, peanuts, wheat, soybeans, sesame.
Crafted with zero-sugar, no sugar alcohols, no artificial flavors, colors or sweeteners and free from gluten and major allergens1, Swisse Beauty Glam Bites are a guilt-free addition to one’s daily beauty routine: just bite, nourish and glow from the inside out!
“Swisse Beauty Glam Bites are a simple and clean addition to your beauty routine” said leading dietitian, Dana. A. White. “They deliver powerful, science-driven beauty benefits through a precisely balanced blend of micronutrients in a zero-sugar gummy that has no artificial colors, flavors, or sweeteners – all with unique flavor profiles and great taste.”
Swisse Beauty Glam Bites are available now, arriving just in time for a fresh New Year beauty routine:
Research shows that 45% of Gen Z and 31% or millennials favor gummy supplements.2 What’s more, 74% of U.S. personal care buyers agree that skin health is a reflection of their overall health 3.
Born in Australia in 1969, Swisse has become a leader in wellness, inspiring millions around the world to enhance their health and wellbeing and celebrate life every day. Now available globally, Swisse products are made with ingredients backed by scientific research and adhere to world-class manufacturing standards, using only the best ingredients sourced from around the world.
Shop for Swisse on Amazon or at https://swisse.us/collections/glam-bites. For more information, visit https://swisse.us/.
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
(1) Major allergens include milk, eggs, fish, crustacean shellfish, peanuts, wheat, soybeans, sesame.
(2) Source: National Business Journal
(3) Source: Kantor Profiles/Mintzel June: 2023; Mintzel GNPD May’19-Apr ’24 and Primary & Secondary Research and AMR Analysis 2023.
About H&H Group North America
H&H Group is a global health and nutrition company with three growing business segments in North America – Baby, Adult and Pet Nutrition and Care – supporting whole-family health and happiness through premium brands providing nutrition and wellness solutions with ingredients backed by science for both pets and people. The consumer brands include Solid Gold Pet, America’s first holistic pet nutrition company, Zesty Paws, a brand of pet supplements, and children’s nutrition brand, Biostime, as well as vitamin, supplement, and skincare brand, Swisse.
SOURCE Swisse
Vitamin C can’t protect you from germs, but it plays an essential role in immune function and overall health. Most women need at least 75 milligrams (mg) per day while men need slightly more, at 90 mg. Rather than relying on supplements, experts generally recommend meeting your needs through food, since it provides additional beneficial nutrients beyond vitamin C alone.
Here are eight foods to eat for vitamin C instead of popping a pill or gummy.
While citrus fruits often get the spotlight for their vitamin C content, many vegetables—including red bell peppers—are surprisingly excellent sources. These peppers also provide vitamin B6, potassium, and magnesium, which support heart, bone, and brain health.
A single cup of kiwi delivers more than your daily vitamin C requirement. For an extra nutrient bonus, eat it with the skin to enhance your fiber intake.
Broccoli is not only rich in vitamin C but also provides immune-supporting nutrients like selenium, zinc, vitamin K, vitamin E, vitamin A, potassium, and phosphorus.
Kale, a nutrition superstar, also contains a noteworthy amount of vitamin C. What’s more, the cruciferous vegetable boasts more than 300% of the DV of vitamin K, crucial for blood clotting, strong bones, and more.
Strawberries deliver an entire day’s vitamin C needs in just a cup. These juicy berries also contain anthocyanin, a powerful antioxidant.
Grapefruit is an acquired taste for some due to its bitter flavor, but its nutritional value more than makes up for it. Rich in vitamin C, fiber, vitamin A, and potassium, grapefruit supports gut, eye, heart, and immune health. “Grapefruit can be enjoyed broiled with a touch of sweetener, added to salads or breakfast bowls, or infused into water for a refreshing drink,” Jennifer Rawlings, RDN, CDCES, owner of My RDN Coach, told Health.
Classically associated with vitamin C, oranges are a great way to simplify your supplement routine. Packed with B vitamins, vitamin E, fiber, calcium, and potassium, oranges can support gut, bone, immune, and heart health.
Brussels sprouts are often celebrated this time of year in comforting recipes like roasted veggies and hearty winter salads. They’re also filled with nutrients beyond vitamin C, including folate, manganese, potassium, phosphorus, magnesium, and fiber.
While people can meet their vitamin C needs with food, supplements may be appropriate for some.
“Individuals who have very poor appetites, limited food choices, certain digestive conditions that affect absorption, are pregnant, smoke, or otherwise may struggle to meet the recommended vitamin C needs through food alone could benefit from supplementation,” registered dietitian nutritionist Dani Dominguez, MS, RDN, told Health.
Experts generally recommend consulting a healthcare provider before starting any dietary supplement—vitamin C included.
Protein Powder Health Risks: The US Food and Drug Administration (FDA) has issued a Class I recall for a protein powder that was distributed across 37 US states on December 11. The recall notice came after large scale consumer reports investigation detailed high lead levels in the Genepro Whey Fourth Generation Plasma Treated Protein, which is an unflavoured protein supplement sold in the market in 225g resealable packaging.
The product that is marketed with a prominent packaging claiming ‘allergen free’, ‘lactose free’ and ‘dairy free’, the USFDA determines that this dietary supplement could contain milk, a major food allergen that must be clearly disclosed to the public under federal law. According to the University of Georgia’s Health Centre, there are two types of whey protein, including isolate and concentrate, the former of which is typically “a highly filtered form of whey protein and contain less than 1% of lactose.”
Most people get enough protein from their daily diet by consuming foods like eggs, chickpeas, a handful of nuts, fish and chicken. However, most people consume protein powder to get vitamins and minerals easily from one item. Experts suggest that if you are a healthy adult who is considering an additional dietary supplement, you should determine whether your goal is to improve muscle mass, as most scientists examined enhancing muscle growth and strength. Researchers claim that protein is beneficial for muscle growth and recovery after exercise.
There are several types of protein powder widely used across the globe for its diverse health benefits, including whey, casein, soy, pea, hemp, beef, and egg. Besides the recent FDA’s recall notice, a 2020 study published by the National Institute of Health (NIH), alarmed that the bestselling protein powder contains heavy metals, such as cadmium, lead and arsenic. The NIH explains, “In 2010, the US Consumer Reports measured heavy metal concentrations in 15 commercially available protein powder supplements, and reported that all of the examined products contained ‘detectable concentrations’ of at least one heavy metal. In a separate evaluation in 2018, the Clean Label Project tested 133 protein powder supplements, and found that all of the tested products similarly contained ‘detectable concentrations’ of heavy metals.”
Suyash Bhandari, Functional Nutritionist, Chief of iThrive Essentials, Supplements Vertical of iThrive says that protein supplements are not harmful by default, but side effects often appear when the protein is not properly digested, absorbed, or broken down by the body. According to the Functional Nutritionist, common complaints involve factors like gas, bloating, and heaviness, especially among people who are lactose or dairy intolerant and consume whey-based proteins.
Additionally, Digestive issues such as loose stools, irregular bowel movements, abdominal discomfort or foul-smelling stools can also occur when the gut keeps struggling to process certain protein sources or additives. In certain individuals, excessive or poorly tolerated protein might show up on the skin as acne, boils, or inflammation, signalling an internal imbalance rather than a protein “problem” itself.
Suyash Bhandari shares three tips to keep handy while purchasing protein powder:
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Beverly Hills MD Dermal Repair Complex, Youth Promoting Supplement Recognized For Its Ability to Support Visibly Firmer, Smoother, and More Radiant Skin
BEVERLY HILLS, Calif., Dec. 17, 2025 /PRNewswire/ — Beverly Hills MD® is proud to announce its best-selling supplement, Dermal Repair Complex™, has been honored with Skin Anarchy’s prestigious 2025 Top Pick Award in the Wellness/Supplements category. This powerful formula is specifically designed to address the root causes of dermal breakdown, helping to restore youthful vitality from within. By promoting visibly firmer and more lifted skin, reducing the appearance of wrinkles, and enhancing overall radiance, Beverly Hills MD Dermal Repair Complex continues to set the standard in advanced skin wellness, earning recognition as one of the top supplements for maintaining a healthy, youthful complexion.
What is Beverly Hills MD Dermal Repair Complex?
Beverly Hills MD Dermal Repair Complex is a groundbreaking anti-aging dietary supplement that works from the inside out to help restore youthful-looking skin. Unlike topical creams that only address surface issues, this advanced formula is specifically designed to combat the root causes of dermal breakdown, including hormonal shifts, collagen loss, and decreased skin hydration. By addressing these key drivers of aging, Dermal Repair Complex helps the skin look visibly firmer, smoother, and more lifted across the entire body.
Users often report a noticeable reduction in wrinkles and sagging, a brighter and more radiant complexion, and renewed confidence in their skin’s appearance. This supplement is unique because it targets age-related changes systemically, meaning its benefits extend well beyond the face to areas such as the neck, chest, arms, hands, and legs. With continued use, Dermal Repair Complex supports long-lasting improvements that help skin look healthier, more resilient, and more youthful overall.
What Ingredients are in Beverly Hills MD Dermal Repair Complex?
The effectiveness of Dermal Repair Complex comes from its carefully selected ingredients, each chosen for its proven ability to support skin health, hydration, and elasticity:
Saw Palmetto – A natural extract that helps reduce the impact of DHT, a skin-aging hormone. By supporting hormonal balance, saw palmetto helps protect collagen and maintain firm, youthful-looking skin while also strengthening hair.
MSM (Methylsulfonylmethane) – A natural compound essential for collagen and keratin production. MSM enhances elasticity, smooths roughness, and calms visible irritation, helping skin look refreshed and resilient.
Hydrolyzed Collagen – Easily absorbed collagen peptides that encourage the body’s own collagen production. This supports improved firmness, reduced wrinkles, and restored plumpness to thinning or crepey skin.
Hyaluronic Acid – A powerhouse hydrator that binds water molecules in the skin to provide lasting moisture. Hyaluronic acid plumps fine lines, improves elasticity, and gives skin a supple, radiant glow.
Vitamins A & B Complex – Vitamin A encourages healthy skin cell turnover and a more even tone, while B vitamins help improve hydration and soothe redness for a calm, balanced complexion.
Alzheimer’s disease (AD), which is a growing concern across the globe, might have found an answer for a better and comprehensive therapy.
The disease, which poses significant challenges in terms of both medical and economic burden, requires treatment and preventive strategies.
According to Mayo Clinic, early symptoms of AD include forgetting recent events or conversations. Over time, Alzheimer’s disease leads to serious memory loss and affects a person’s ability to do everyday tasks.
Researchers at the Institute of Nano Science and Technology (INST) explored a new path involving nanoparticles integrating a polyphenol with antioxidant properties found in green tea, neurotransmitter, and amino acid to treat AD.
According to experts, the new treatment strategy alters the progression of the disease, slowing it down, improving memory, and supporting thinking skills.
The conventional therapies often target only a single pathological feature, such as amyloid aggregation or oxidative stress.
The proposed therapy involved the integration of epigallocatechin-3-gallate (EGCG) an antioxidant found in green tea, dopamine, a neurotransmitter important for mood and tryptophan, an amino acid involved in many cellular functions, into a nanoparticle called EGCG-dopamine-tryptophan nanoparticles (EDTNPs).
The benefit of the nanoparticle is that it acts on multiple targets, such as amyloid aggregation, oxidative stress, inflammation, and neuronal degeneration. It also helped in enhancing neuronal regeneration.
On testing on mouse models, it was observed that these nanoparticles disassembled toxic plaques, reduced inflammation, restored balance inside brain cells, and even improved memory and learning.
Published in the journal Small, experts believe the new therapy path could help people with AD and, in the long run, could make life easier for patients by offering better treatment strategies.
All men need to be more careful before taking supplements now.
The FDA urgently announced the recall of a “male enhancement” supplement after it was discovered that the product contained two erectile dysfunction drugs that were not declared on the label.
StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules, sold as a dietary supplement, after testing showed the product contained erectile dysfunction drugs sildenafil and tadalafil.
Sildenafil, sold under the brand name Viagra and Revatio, and tadalafil, sold under the brand name Cialis, are FDA-approved prescription drugs and active ingredients used to treat male erectile dysfunction.
They belong to a class of drugs known as phosphodiesterase type 5 (PDE 5) inhibitors, and products containing sildenafil or tadalafil cannot be marketed as dietary supplements, the FDA recall noted.
MR.7 SUPER 700000 is an unapproved product and safety and efficacy have not been established for it.
The FDA does not regulate dietary supplements with the same procedures that the use for prescription drugs, however, the agency does step in to issue warnings and recalls after a problem has been reported.
While they are FDA-approved, taking sildenafil and tadalafil carries notable side effect risks, including headache, indigestion, back pain, muscle aches and dizziness.
The male enhancement product was distributed nationwide “to a limited number of online customers between August 2025 and November 2025,” according to the FDA.
Taking sildenafil or tadalafil can be dangerous for the millions of people taking medication to treat chest pain, such as nitroglycerin. Combining them can result in a critical drop in blood pressure.
This can cause dizziness, fainting, falls, heart attack or stroke due to the brain and heart not receiving enough blood flow.
In Tokyo’s quiet season, the city slows to a simmer. Steam curls from teapots and kitchen windows, carrying whispers of charcoal, broth and roasted leaves. Hands cradle cups; laughter softens over wooden counters. Outside, cold air chills the streets, but inside, time stretches. At these restaurants, tradition isn’t just food, it’s rhythm: a pause, a pour, a shared silence before the next bite. The kind of comfort that lingers through centuries.
If sweet and chilly is something right up your alley, check out our article on Cafe Lumiere’s Tokyo Christmas Kakigori.

Marie Kondo minimalism meets the Japanese tea ceremony in a secluded Zen retreat. Sakurai Japanese Tea Experience is exactly that: an experience steeped in centuries of craft and quiet refinement. It’s an escape from reality, a time-warp portal disguised as a tea shop. How else could a single order of green tea last over an hour? In winter, the air feels warmer here, fragrant with the smoky, hypnotic scent of roasting leaves. The aroma drifts through the space, drawing you in from the cold. Choose your path: a winter course of gyokuro, blended teas, hojicha, matcha and sparkling tea. The staff present a wooden tray of five teas to smell, each carrying its own landscape of vibrant green fields, oven-roasted curls or cold dew on pine needles. If you hesitate, I’d nudge you toward Soufu Yamacha from Fukuoka, umami-rich and deeply soothing. The tea masters move with quiet precision, their white embroidered coats recalling a time when tea was medicine. From your counter seat, watch steam rise as she pours your first cup. “Drink slowly.”

Above the fan-shaped glass facade and dark gray titanium roof, a fierce kanji emblem reads tora, tiger, hinting at the legacy within. Step through ya-ra-to, the backward-facing noren curtain, where an ikebana display greets you beside an attentive receptionist. Soft classical music floats through the minimalist space. Five centuries of Japanese sweet-making unfold here, a modern shrine to wagashi craftsmanship. Behind glass, artisans dressed in white shape each delicate confection by hand as sunlight spills across hinoki-paneled walls and polished counters. Upstairs, an airy shop displays hanabira mochi and other New Year wagashi beside Toraya’s signature yokan jelly and smooth sweet-bean paste. Put your name down early for the third-floor tea hall. Even at peak hours, the wait is worth it. Order the Akasaka seasonal lunch, served with your choice of wagashi. Eighteen generations later, your number is called. Each gently sweet bite melts on your tongue, followed by a warm, earthy sip of tea that lingers like a kiss. The black lacquered tray catches the light of your smile.

The blue-green glow of FamilyMart signs hums behind you as taxis slip through Shinjuku’s backstreets. Ahead stands a white three-story building, its exterior divided by inky black stripes like bold brushstrokes. A deep, lacquered red wraps the roofline and the lattice grates that frame the upper windows. At the entrance, a softly lit lantern bears the name Genkai, “mystic sea,” written in bold vertical script. Inside, warmth radiates from private tatami rooms where families and friends gather around steaming pots of mizutaki. Since 1928, Genkai has served this simple yet elegant chicken hot pot, its milky-white broth made with Date chicken from Fukushima and simmered through the founder’s original fukikoboshi “boil-over” method that draws out pure umami and collagen. A kimono-clad attendant quietly interrupts to add rice to the remaining broth. The stock deepens, richer now, with shared laughter and rising steam. After a long year, a meal like this reminds you what endures—and why you keep going.

New Year in Tokyo feels hushed. The city empties as warm green tea fills porcelain cups and sweets rich with meaning take center stage. At Eitaro Sohonpo’s Nihonbashi flagship, history begins beneath your feet. The granite paving stones at the entrance remain unchanged since the shop opened here in 1857. To your right, the E-Chaya Café serves nadai kintsuba, an Edo-era azuki bean sweet grilled to order. A coffee set with sweet bean and butter toast offers a gentle comfort. Toward the back, glass cases display soft, seasonal mochi filled with koshi-an red-bean paste. Pick up an omiyage box of kuromitsu manju (available through December) or butter dorayaki before stepping back into the chilly, ginkgo-lined streets. Just as the New Year does each year, Eitaro bridges time, from Edo to Reiwa, tradition to innovation. Then, at that first chewy bite of mochi, you taste how the years have folded into now.
Looking for more festive eats? Here’s our guide to Christmas and Holiday Dinners around Tokyo.
The U.S. Food and Drug Administration is moving toward a controversial change in how warning labels appear on dietary supplements, which would reduce how often key disclaimers must be displayed on product packaging.
Under long-standing federal law, dietary supplement makers must include a boldface disclaimer when their products make health claims such as “supports immune health” or “promotes heart health.”
That language states that the claim “has not been evaluated by the Food and Drug Administration” and that the product “is not intended to diagnose, treat, cure, or prevent any disease.”
These warnings are intended to remind consumers that supplements are not evaluated for safety or effectiveness before they go on sale.
In a letter to manufacturers last week, the FDA’s food division head, Kyle Diamantas, said the agency is considering relaxing the rule so companies would still be required to include the disclaimer at least once on their labels, but would no longer need to repeat it every time a health benefit is referenced.
Diamantas said the FDA has seldom enforced the current rule and that easing it would reduce label clutter and costs. He added that no timeline has been set for the change and that the agency will not enforce the existing requirement while the policy is under review.
“If FDA does not identify significant concerns as we continue our review of the available data and information regarding this request, we are likely to propose a rule to amend this requirement,” Diamantas wrote in the letter.
About 75 percent of Americans use at least one supplement, and up to 100,000 supplement products are sold in the U.S., according to the FDA.
Dr. Pieter Cohen of Harvard Medical School warned that the FDA’s move could further weaken already limited warning labels on dietary supplements.
“Then you start saying things like, ‘We only need it on the actual bottle,’” Cohen told NBC News. “Then you say, ‘It only needs to be on the back.’ Then you let the print get smaller.”
Department of Health and Human Services spokesperson Andrew Nixon told the outlet in a statement that the change would not make warnings harder to notice, claiming that “a growing number of Americans are paying closer attention to product labels.”
The Independent has contacted the White House and HHS for comment.
Dietary supplements have gained prominence among figures associated with the Make America Healthy Again movement.
Dr. Mehmet Oz, now administrator of the Centers for Medicare and Medicaid Services, faced criticism during his March confirmation hearing for previously promoting supplements he labeled a “magic weight loss cure” and a “miracle in a bottle,” NBC reports.
Health Secretary Robert F. Kennedy Jr., who has said he personally takes many supplements, has also argued the Trump administration should loosen oversight, saying it would free Americans from what he described as the FDA’s “aggressive suppression” of vitamins and dietary supplements.
A proposed rule change regarding the placement of DSHEA disclaimers on dietary supplement labels has been seen as a welcome clarification by industry sources. FDA has rarely if ever enforced the existing rule, but the issue has given rise to class action lawsuits.
The Dietary Supplement Health and Education Act (DSHEA) specifically requires that the standard disclaimer relating to claims be printed on every panel of a product label on which a health claim appears.
The standard verbiage is: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Over the years the practice in the industry has become to refer to a lone disclaimer, often but not always located on the back panel of the product label, via asterisks appended to each appearance of a claim. While that does not fulfill the letter of the law, in a statement announcing the proposed rulemaking procedure, FDA said it “recognizes that we have rarely, if ever, enforced this requirement.”
FDA’s proposed rule change would allow the currently accepted industry practice to be formally codified in the law. At least one appearance of the disclaimer would still be required, however.
That de facto enforcement discretion on FDA’s part hasn’t stopped the plaintiff’s bar from seeking to capitalize on this perceived lapse on the part of dietary supplement companies. As the Council for Responsible Nutrition (CRN) noted in a recent press statement, “[A] recent uptick in class-action lawsuits has relied on an alternative interpretation, arguing that the full disclaimer must be placed on every panel where a structure/function claim is used on a product label. These legal challenges have created confusion, prompted unnecessary litigation, and imposed costly and disproportionate burdens on responsible manufacturers — without improving consumer understanding.”
Ivan Wasserman, partner in the law firm Amin Talati Guarani, was effusive in his praise of the move.
“This development is certainly welcome news to all of us in the industry. It is public acknowledgement of the enforcement discretion that we all know FDA has been unofficially exercising for decades, and we hope FDA will ultimately revise the regulation. It provides peace of mind to everyone trying to label supplements correctly, and will hopefully help put an end to at least this one labor of whack-a-mole class actions. Our firm was thrilled to be part of the catalyst for this by assisting CRN in drafting its submission to FDA advocating for this change,” he told SupplySide Supplement Journal.
Wasserman noted that the change was announced via a “letter to industry” rather than a guidance document. He speculated that this is in response to the first Trump administration’s executive order against using guidance documents rather than rulemaking procedures as standard regulatory tools.
The practice has grown in recent years because of the many months to years required to conclude a formal rulemaking procedure. The argument in favor of rulemaking is that the rule can be challenged in court, giving some potential redress if stakeholders believe the process has gone awry.
The Natural Products Association (NPA) and the American Herbal Products Association (AHPA) had collaborated on a similar submission to FDA, and NPA’s president and chief executive officer Daniel Fabricant, Ph.D., said the change will ease burdens for industry.
“NPA appreciates that FDA carefully considered the concerns of industry over the requirement for the DSHEA disclaimer to appear on each panel of a dietary supplement product label where an applicable claim is made. Our association will continue to advocate for dietary supplement rules that ease undue burdens on our members, reduce frivolous litigation and protect the integrity of DSHEA,” he said.