FDA approves 3 color additives as part of RFK Jr. dye ban effort
Why it matters: Officials said more food manufacturers are voluntarily committing to removing petroleum-based dyes over Kennedy's two-year time frame, even as food and industry experts question the necessity of alternatives.
The big picture: Last month, Kennedy and FDA Commissioner Marty Makary announced what they termed "an understanding" with food makers to remove eight common artificial dyes from their products.
Kennedy and other officials argue that research into the health effects of these ingredients has been largely stifled, and point to increasing rates of childhood illnesses like obesity, diabetes and ADHD as justification for substituting natural ingredients.
Details: The newly approved dyes include two different colors of blue and a white.
One blue colorant from the French company Fermentalg, is derived from an algae and was approved for use in nonalcoholic beverages and beverage bases, breakfast cereals, hard candy and other products.
A second dye made from butterfly pea flower extract and submitted by St. Louis-based Sensient Colors already used to achieve bright colors in sport drinks and alcoholic beverages was approved for expanded use in ready-to-eat cereals, crackers, snack mixes and chips.
A white color made from calcium phosphate made by New Jersey-based Innophos Inc. was approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
Yes, but: Experts have warned against the fallacy that chemicals or compounds with hard to pronounce names are by definition "bad" while natural ingredients are necessarily "healthy."
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Buzz Feed
3 hours ago
- Buzz Feed
Best & Worst Hot Dogs Ranked By Nutritionists
OK, so hot dogs aren't the world's healthiest food, but admit it: If they weren't on the menu at summer barbecues, it'd feel like losing a friend. Fortunately, with a growing number of healthier hot dogs hitting supermarket shelves, it's become possible to indulge and still go easy on your body. You just need to know what to look out for. First things first: 'Avoid traditional or ballpark-labeled hot dogs,' Nicole Avena, a New York-based nutrition consultant, told HuffPost. 'These are usually the highest in sodium and contain the most additives and preservatives.' All processed meats are a health risk ― they've been linked to certain types of cancer, like colorectal cancer, because of the way they're preserved. But there are a few types of meat that offer less risk than the standard beef hot dog, Avena said. Look for a label that indicates whole beef, turkey or chicken, as opposed to mechanically processed and separated meats. Another important factor is sodium content. 'Choose hot dogs that have less than 400 mg (or less than 20% of the daily value) of sodium per serving,' said Gretchen Zimmermann, senior director of cardiometabolic care for Vida Health. (The Dietary Guidelines for Americans recommend that adults limit sodium intake to less than 2,300 mg per day.) Other indications of a higher-quality hot dog are if they're uncured and nitrate- and nitrite-free, and have minimal ingredients. 'Overall, uncured chicken or turkey hot dogs would be a better option, because they're usually lower in saturated fat and less processed than beef,' Avena even if the label says 'uncured,' 'no nitrates added' or 'all natural,' it doesn't mean these options are necessarily healthier. Natural preservatives, such as celery powder and celery salt, may sound better, but there's no evidence they're safer, so it's still best to minimize your intake. The same goes for veggie dogs: Choose dogs with minimally processed ingredients, such as tofu, instead of heavily processed soy protein concentrate or isolate. 'An occasional processed veggie dog isn't likely to be harmful, but these soy ingredients haven't been well-studied, so there are still some concerns about their safety,' said Samantha Cassetty, nutrition expert and co-author of Sugar Shock. To save you time scanning nutrition labels, here are the healthiest and the least healthy store-bought hot dogs, according to nutritionists. A healthy beef option: Organic Valley Uncured 100% Beef Hot Dogs 'The Organic Valley hot dogs boast healthy ingredients like organic grass-fed beef, organic spices, garlic and onion powder (although celery powder is used as a preservative),' Zimmermann they're uncured, this makes them your best bet for avoiding high amounts of carcinogens -- and compared to traditional dogs, they're lower in calories, sodium and saturated fat. A healthy beef option: Applegate Naturals Do Good Dog Uncured Beef Hot Dogs Applegate Naturals Do Good Dogs are made with regeneratively sourced beef that's 100% grass-fed. They use just four simple ingredients: beef, water, salt and spices.'You are what you eat, and a healthier diet for the animal you're consuming means a healthier diet for you too,' said Marissa Meshulam, a registered dietitian based in New York City. An unhealthy beef option to avoid: Ball Park Brand Prime Uncured Beef Franks Even though the packaging says 'uncured,' it only takes one glance at the nutrition facts to know these hot dogs aren't the best Dietary Guidelines for Americans recommend limiting calories from saturated fat to less than 10% of one's total calories per day to promote heart health. 'A 2,000-calorie diet would equate to less than 20g of saturated fat per day,' Zimmermann said. 'The Ball Park Prime Uncured Beef Franks provides nearly half that amount in one serving.' Even before the bun, ketchup and other salty condiments and accessories are added, these hot dogs pack a whopping 710mg of sodium in one serving, as well as 230 calories, 20g of fat, 9g of saturated fat, 2g of carbohydrates and 9g of protein. Bottom line: Yikes. A healthy pork blend: Applegate Naturals Natural Stadium Beef and Pork Hot Dogs 'Applegate Naturals uses antibiotic-free beef and pork to make these without any preservatives — just natural spices and herbs,' said Amy Shapiro, a New York-based registered dietitian. The franks contain no fillers and no added nitrates or nitrites (except for those naturally occurring in sea salt and celery powder). A healthy pork blend: Seemore La Dolce Beet-a Pork Sausages The pork used to make these sausages is animal welfare-certified, and the dogs themselves are minimally processed. 'Plus, the brand adds fresh beets, garlic and fennel, which further boosts the nutrient content,' Meshulam are no preservatives or phosphates, and the only nitrates or nitrites are those that naturally occur in cultured celery powder and sea salt. An unhealthy pork blend to avoid: Kayem Beef & Pork Hot Dogs These dogs contain a boatload of fat and sodium, as well as corn syrup and dextrose (two types of added sugar), mystery flavorings and preservatives. 'This can indicate the company uses pork byproducts to produce their product, not lean pork or beef,' Avena said. A healthy turkey option: Organic Valley Uncured Pasture-Raised Turkey Hot Dogs These turkey hot dogs are made using meat from animals that have been humanely raised, and the hot dogs are free from fillers and potentially harmful salt sources like sodium nitrates and nitrites, Zimmermann said. They also contain 20% less sodium than the leading organic brand. A healthy turkey option: Applegate Natural Uncured Turkey Hot Dog The turkey dogs from Applegate Farms are as clean as it gets — the turkey is organic and humanely raised with no antibiotics, and the hot dogs themselves contain no fillers or preservatives. 'They simply contain organic turkey and organic spices and herbs,' Shapiro said. 'They're a lean and light option, coming in at 70 calories each with under 4g of fat.' An unhealthy turkey option to avoid: Ball Park Brand White Meat Smoked Turkey Franks Ball Park's turkey franks contain mechanically separated turkey, which, 'to keep it simple, means the meat isn't coming from a good part of the turkey,' Meshulam said. 'It's more likely ground-up bone paste.' They're also loaded with sodium, at almost 600mg per dog. ('That's more than I recommend in a full frozen meal,' Shapiro said.) A healthy chicken option: Applegate Organics Great Organic Uncured Chicken Hot Dog 'This is an excellent choice for a hot dog with just a handful of ingredients, including organic chicken, water, sea salt and spices,' Zimmermann said. 'There are no artificial or naturally occurring nitrate or nitrite sources either, like celery powder, making it one of the best summer grilling hot dog options.' A healthy chicken option: Bilinski's Mild Italian Chicken Sausage with Bell Peppers The line of chicken sausages by Bilinski's are another excellent summer grilling option. 'Not only are they made with only organic chicken breast, water and spices, they're pretty lean,' Meshulam said. The brand's mild Italian option has only 2.5g of fat per dog (0.5g of that being saturated fat) and 13g of protein. An unhealthy chicken option to avoid: Gwaltney Original Chicken Hot Dogs While Gwaltney's chicken dogs are lower in fat, they contain mechanically separated chicken, which means 'you're not just eating chicken meat, but also tendons, veins and skin,' Shapiro said. On top of multiple sodium sources in the ingredients, this hot dog uses 'natural' flavors, which may contain unknown chemicals added during the manufacturing process. 'The word 'natural' isn't regulated by the FDA and can mislead consumers,' Zimmermann said. 'Overall, the high sodium content and long list of ultra-processed ingredients make this chicken dog a no-go.' A healthy vegetarian option: Upton Naturals Updog Vegan Hot Dog This vegan hot dog alternative has a texture similar to meat. 'It contains 19 grams of protein from vital wheat gluten or seitan (the main protein of wheat),' Avena said. 'The limited ingredients and preservatives make it a great meat-free hot dog option.' A healthy vegetarian option: Jack & Annie's Jackfruit Sausages Many 'not dogs' out there contain iffy ingredients (like soy protein isolate), inflammatory oils (canola) and lots of stabilizers and additives to make them taste good. 'While they're 100% better for the environment, they're still very processed products and may not be that much better for your health,' Meshulam said. Instead, go for a real plant-based protein (like tofu, beans or legumes). Jack & Annie's Jackfruit Sausages, for instance, are made with a base of jackfruit — a plant that eats like your favorite meat — and prepared with natural seasonings. An unhealthy vegetarian option to avoid: Lightlife Smart Dogs To make these non-meat dogs taste like meat, Lightlife uses a lot of processed ingredients, including soy protein isolate, 'a very processed and broken-down form [of] soy I tell my clients to avoid,' Shapiro said. 'They also use three different sweeteners, soy and canola oil, guar gum and xanthum gums, too — so many ingredients that cause inflammation in the body.' What if your favorite hot dog is one of the 'unhealthy' options listed above? If any of your go-to dogs made the 'steer clear' list, it doesn't mean you have to ghost them. 'Going to barbecues and eating less healthy foods are part of living a joy-filled life,' Cassetty advice? If you feel that no family barbecue is complete without a Ball Park frank in your hand, then have one and enjoy. Just don't make hot dogs a way of life.'The occasional hot dog at a barbecue when you're otherwise eating a mostly healthy diet isn't going to wreck your health,' Cassetty said. 'So pick the one you'll enjoy and be mindful of your diet as a whole.'
Yahoo
3 hours ago
- Yahoo
ACHV: Achieve's Busy Day
By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) posted a flurry of press releases last week announcing the submission of its new drug application (NDA), a partnership with Omnicom for cytisinicline commercialization, a proposed public offering and the pricing of the offering. The capital raise was closed on June 30th. This is the culmination of more than a decade of work developing cytisinicline for smoking cessation. Now that the development phase of cytisinicline for smoking cessation is coming to a close, we look towards the regulatory and commercialization phases. We expect to see the FDA formally accept the NDA by late August and Achieve's management team to turn its attention towards the sales effort. Assuming normal turnaround times, we expect the FDA to set a target action date sometime in 2Q:26. NDA Submission Achieve announced its NDA submission of cytisinicline for smoking cessation in a June 26th press release. The company conducted two Phase III studies, an open label safety study and other studies that evaluated over 2,000 participants with the results demonstrating the safety, efficacy and tolerability of cytisinicline. We expect to see acceptance of the NDA within 60 days and further expect additional safety data from the ongoing ORCA-OL trial to be shared with the agency near year end. Commercialization Partnership Now that the new drug application has been submitted, Achieve is further advancing its commercialization efforts. During its earnings calls, the company has outlined its commercialization strategy and is now partnering with Omnicom Group to execute the plan. Omnicom Group provides brand and advertising services to thousands of clients globally and is one of the world's largest advertising and marketing services companies. Achieve will work with Omnicom subsidiary Credera, which is focused on digital transformation services. Credera combines consulting, artificial intelligence (AI) and technology expertise to build consumer technology platforms, integrate marketing technology systems and provide strategic consulting services. It will help Achieve to precisely target and engage healthcare professionals and patients through optimization of channel performance and acceleration of meaningful engagement. The team executing the initiative will include Goodby, Silverstein & Partners, DDB Health, and Ketchum Health which are health care-focused subsidiaries of the Omnicom marketing group. The various subsidiaries will provide expertise in consumer brand development, medical education and strategic public relations and communications, applying industry insights to support cytisinicline launch. In the Achieve partnership, Ketchum Health brings public relations and communications expertise, while Credera handles technology, Goodby Silverstein provides creative advertising, and DDB Health focuses on healthcare marketing. The partnership will use generative AI, predictive analytics and social listening to enhance targeting and personalization. Using a comprehensive approach, it will also employ healthcare applications, pharmacies and data providers to expand the reach and depth of insights. Omnicom has worked as media agency, digital and brand experience for other pharmaceutical and biotechnology clients including established firms such as AbbVie, AstraZeneca, Novartis and Moderna among others. Achieve will be the first small company that Omnicom has supported in commercializing a newly approved drug. Therefore, Omnicom will take on a broader strategic role than in its past partnerships. The Omnicom team will help communicate the optimal message to the provider and patient and monitor its effectiveness in real time. This will allow for rapid course corrections and focus on high value activities. Achieve has identified several target groups for its marketing efforts that are stratified by age, social media use and other demographic data. It was able to identify these groups based on subject experiences in the company's many clinical trials. We anticipate that the structure of Achieve's internal marketing team will be heavily tilted toward supporting the digital campaign with contract representatives available for in-person physician meetings when appropriate. Public Offering On June 30th, 2025 Achieve closed its $45 million capital raise. 15 million shares were issued at $3.00, each of which included an attached warrant exercisable at $3.00 per share. An additional 1,766,666 warrants were issued upon the partial exercise by the underwriters of their option to purchase additional shares, bringing total issued warrants to approximately 16.8 million. Net proceeds from the capital raise are estimated to be $41.3 million as disclosed in the June 27th Form 8-K filing. ORCA-OL Safety Trial Achieve began 2025 by announcing that 300 participants had completed six months of treatment in the Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial. The Data Safety Monitoring Committee (DSMC) identified no safety concerns as of this milestone allowing registrational filing with the FDA. As of May 2025, a third DSMC safety review was completed which also found no unexpected treatment-related adverse events. As of the first quarter reporting date, more than 100 subjects had completed one year of cytisinicline treatment. Furthermore, about 75% of the 479 (~360) individuals remained on treatment in the trial. We think that it is a material real-world positive that so many participants would remain on a smoking cessation product for that long a period suggesting that cytisinicline is well tolerated. This is particularly notable given the high discontinuation rates for Chantix and the associated unpleasant side effects such as nausea, headache, abnormal dreams and constipation.[1] Achieve expects to complete the one-year safety data package in the next few months and will submit this to the FDA by the 120-day safety review milestone. This should be around year-end 2025. Achieve expects that it will far exceed the 100-patient minimum required for one year of safety observations and could see as many as 300 patients with one year of exposure. Since one of the secondary endpoints is efficacy, this study should be able to show a wealth of data that can help providers use cytisinicline more effectively especially in chronic areas of disease such as Chronic Obstructive Pulmonary Disease (COPD) and cardiology. Milestones Development of cytisinicline product label for smoking cessation – 1H:25 Completion of six months of ORCA-OL safety data for 300 subjects – January 2025 Attendance at Oppenheimer Healthcare Life Sciences Conference, Virtual – February 2025 Attendance at Barclays Healthcare Conference, Miami – March 2025 Selection of 3rd party logistics partner – 2Q:25 NDA Submission – 2Q:25 FDA data submission from patients with twelve months of exposure to cytisinicline – 4Q:25 Launch of Phase III vaping trial – 1H:26 FDA target action date for cytisinicline NDA – 1H:26 Launch of cytisinicline – 3Q:26 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer . ________________________ [1] Minian, N., et al. Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review. BMC Public Health. March 2024.
Forbes
6 hours ago
- Forbes
Smoking Cessation Aid Cytisinicline Could Soon Get FDA Approval
There are multiple smoking cessation products on the market. But there hasn't been a new approval of ... More a pharmacotherapy without nicotine in nearly 20 years. This could change soon, as cytisinicline was submitted to the FDA for approval on June 26, 2025. More than two-thirds of American smokers say they want to quit. However, besides nicotine replacement therapies, there are at present only two smoking cessation drugs without nicotine that are authorized for marketing by the Food and Drug Administration. This could change soon, as the pharmaceutical firm Achieve Life Sciences submitted to the FDA a new drug application last week for its prescription medicine, cytisinicline, also known as cytisine. The agency will review the medication's efficacy, safety, and tolerability profile based on evidence from two large, placebo-controlled Phase 3 clinical trials. The substance is a naturally occurring plant-based alkaloid that selectively binds to nicotinic receptors in the brain. In turn, this can help alleviate nicotine cravings and reduce withdrawal symptoms, among smokers of combustible cigarettes as well as e-cigarettes (vaping). Cytisinicline has been used as a smoking cessation product for decades in some Central and Eastern European countries. It was approved by the British Medicines and Healthcare products Regulatory Agency in March 2019, though only available commercially in the United Kingdom since January 2024. Cytisinicline hasn't yet been approved by the European Medicines Agency. The Journal of the American Medical Association Internal Medicine published results from one of two Phase 3 trials evaluating cytisinicline for smoking cessation. The authors' conclusions reaffirmed cytisinicline's efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. Additionally, a study published in 2024 suggested cytisinicline could be effective for e-cigarette cessation. Owing to its mechanism of action as a way to reduce nicotine dependence, it's possible that cytisinicline could be beneficial for individuals using nicotine pouches who wish to stop, though this hasn't yet been examined specifically. Based on a technology assessment of the benefits and costs of cytisinicline, the British cost-effectiveness watchdog, the National Institute for Health and Care Excellence, recommended earlier this year adding the drug to the National Health Service as a treatment option for smoking cessation. And this week, the American Institute for Clinical and Economic Review announced it is conducting an evidence review to assess the clinical effectiveness of cytisinicline together with behavior support. The evaluation will include comparisons with other existing smoking cessation products. Smoking is the leading cause of preventable death in the U.S. Cigarette smoking is responsible for more than 480,000 deaths annually in the U.S. The major causes of death associated with smoking include cardiovascular diseases such as strokes and heart attacks; cancers, among which lung, pancreatic, esophageal, bladder, colorectal and renal; and pulmonary conditions such as chronic obstructive lung disease, pneumonia and bronchitis. Last October, the FDA and the National Institutes of Health convened a public meeting to address the urgency for developing novel smoking cessation products to assist individuals of all ages, including underserved and vulnerable populations, to stop smoking. There is unmet need in this space, reflected in the fact that of the 15 million who tried to quit smoking in 2022, five in six failed, according to STAT News. Experts cite a lack of sufficiently effective smoking cessation drugs. Should cytisinicline become available in the U.S. it could represent an important option for those who wish to quit their nicotine habit. At the same time, it will continue to be critical for healthcare providers and public health authorities to raise awareness around the importance of smoking cessation and prevention, provide behavior support (counseling) and offer treatment alternatives people can use to quit. The U.S. has made real progress since the 1960s in reducing cigarette smoking, mainly through effective public health campaigns. Yet there's still a lot more work to do as roughly 29 million adults smoke combustible cigarettes and approximately 17 million use e-cigarettes. But under the Trump administration the Department of Health and Human Services has cut funding for smoking cessation and prevention programs, as well as eliminated the Centers for Disease Control and Prevention's Office on Smoking and Health. While the CDC says it will continue to provide resources for those who wish to quit smoking while conducting ongoing surveillance, experts warn that cuts in services could limit access, which could then result in a resurgence in smoking rates.
