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Yahoo
6 days ago
- Business
- Yahoo
Amino Acids Market Size to Hit USD 66.35 Billion by 2034
The global amino acid market is experiencing robust growth driven by rising consumer health awareness, increasing dietary supplement use, demand from pharmaceutical and animal feed industries, and government-backed nutritional initiatives. Asia Pacific dominated in 2024 due to large-scale production and policy support, while Europe is set for rapid growth amid regulatory shifts favoring amino acid use over antibiotics in livestock. Ottawa, July 15, 2025 (GLOBE NEWSWIRE) -- According to Towards chem and Materials consultants, the global amino acids market size was valued at USD 29.21 billion in 2024 and is expected to hit around USD 66.35 billion by 2034, growing at a CAGR of 8.55 % from 2025 to 2034. A study published by Towards chem and Materials a sister firm of Precedence Research. The market is growing with rising consumer health awareness tapering, increased incidence of dietary supplement use, demand from pharmaceutical, and animal feed industries and nutritional initiatives backed by government, as well as innovation with amino acid-based products. The amino acid market refers to the manufacturing and selling of organic compounds that are the building blocks of proteins that appear in many different sectors such as pharmaceuticals, food & beverage, animal feed, and cosmetics. The role of amino acids is crucial as they are biomolecules involved in metabolic processes and the base of dietary supplements and therapeutics. The market is growing driven by the increased demand for protein in diets and the outset of more nutraceutical applications and health and wellness awareness. The increases in efficiency from the developments in fermentation processes and synthetic biology are also being translated into the production capacity of amino acids across the end-use industries, making this once specialized compound available for general consumption, accessible through an array of different products. Get All the Details in Our Solutions –Download Sample: What are the Major Trends in the Amino Acid Market? Growing Demand for Plant-Derived Amino Acids- Increasing veganism and plant-based eating habits is forcing companies to make amino acids from non-animal sources, ultimately for food supplements and sports nutrition. This demand will continue to foster novel and diverse products in the overall market segment. Growth in Personalized Nutrition- Personal health diets and individualized health solutions are all growing sectors of the food ingredient industry. The new emphasis on personalized nutrition has created demand for amino acid based nutrition products. This is particularly true with respect to controlling metabolic disorders, muscle recovery, and health through personalized supplements. Technological Advances in Fermentation- Innovations in biotechnology in the area of microbial fermentation are making amino acids affordable, scalable, and sustainable. Companies are able to use fermentation as an alternative to traditional chemical synthesis routes and in the continual need for non-animal-based feedstock. How Artificial Intelligence is changing the Amino Acid Industry Artificial intelligence (AI) has the potential to increase efficiency of production in the amino acid market, optimize fermentation, and use predictive quality control. In May 2024, the company Evonik will adopt AI-based modelling to improve accuracy in amino acid synthesis, leading to a decrease in carbon waste and energy consumption. AI can also be used to model demand signals and patterns as it pertains to food additives for animal feed and dietary supplements, all signals useful to companies like Ajinomoto and ADM as they work to stabilize supply chains. Additionally, start-up companies are using AI to streamline the discovery of new amino acid formulations to develop personalized nutrition. The amino acid sector is positioned for a new intelligence and more accessibly sustainable future given the integration of AI. Growth Factor Is the Increased Demand for Protein-Rich Diets Driving a Growth in Amino Acids? A key factor for the amino acid market is the worldwide shift to protein-rich diets, endorsed by government and health organizations. For example, the World Health Organization (WHO) stresses the importance of consuming protein to reduce under nutrition, especially in developing areas. In the U.S., the Dietary Guidelines for Americans (2020-2025) state that people will benefit from protein intake across age groups. India's Food Safety and Standards Authority of India (FSSAI) recently implemented an "Eat Right India" initiative that promotes protein in daily food. The growth in demand for amino acids is especially being felt for use in nutritional supplements, functional foods, and fortified beverages, which are primarily for athletes, older adults, and vegans who want to acquire essential amino acids. Market Opportunity Is the Growth of Plant-Based Nutrition Creating New Opportunities for the Amino Acid Market? The plant-based nutrition market offers significant opportunities for the amino acid market. As consumers embrace more vegan and vegetarian lifestyles, there is rising demand for amino acids derived from plants to assertively fill product nutritional gaps. According to the Good Food Institute 59% of U.S. households purchased plant-based foods in 2024, like the prior year, which is creating a variety of new opportunities for product innovation in the plant-based and fermented amino acid formulations. Companies like ADM and Evonik have expanded fermentation-based production to meet the growing demand for fermented, plant-based alternatives. Innovations in precision fermentation have expanded the availability of environmentally friendly and clean-label amino acids that affordably meet both consumer and market demand. This is an important trend aligned with the expanding consumer concerns for health, sustainability, and ethical procurement of sourcing all of which is positioning plant-based amino acids for sustained growth in the food, nutraceutical, and personal care markets. Limitations and Challenges in the Amino Acid Market Raw Material Price Volatility- Amino acid purchasing largely depends on agricultural products, especially soybeans and corn. Variations in crop yield due to local weather conditions or global trends can create unsteady raw material availability and ultimately higher production costs, affecting overall profitability. Stringent Regulatory Standards- For many regions, the food safety and pharmaceutical standards are stringent and in fact can often delay product feature approvals. Companies must ultimately conform to various standards established as authorities to like the FDA or EFSA, which also postpones product delivery to the market and adds costs. Limited Awareness in Underdeveloped Regions- Many developing countries may still have limited awareness of amino acid supplementation and its benefits - especially in human health/nutrition, leading to limited market support in these regions and trailing developed economies in adoption. Explore Strategic Figures & Forecasts – Access the Databook | Immediate Delivery Available: What are the different types of amino acids? Your body needs 20 different kinds of amino acids to function correctly. These 20 amino acids combine in different ways to make proteins in your body. Your body makes hundreds of amino acids, but it can't make nine of the amino acids you need. These are called essential amino acids. You must get them from the food you eat. The nine essential amino acids are: Histidine: Histidine helps make a brain chemical (neurotransmitter) called histamine. Histamine plays an important role in your body's immune function, digestion, sleep and sexual function. Isoleucine: Isoleucine is involved with your body's muscle metabolism and immune function. It also helps your body make hemoglobin and regulate energy. Leucine: Leucine helps your body make protein and growth hormones. It also helps grow and repair muscle tissue, heal wounds and regulate blood sugar levels. Lysine: Lysine is involved in the production of hormones and energy. It's also important for calcium and immune function. Methionine: Methionine helps with your body's tissue growth, metabolism and detoxification. Methionine also helps with the absorption of essential minerals, including zinc and selenium. Phenylalanine: Phenylalanine is needed for the production of your brain's chemical messengers, including dopamine, epinephrine and norepinephrine. It's also important for the production of other amino acids. Threonine: Threonine plays an important role in collagen and elastin. These proteins provide structure to your skin and connective tissue. They also help with forming blood clots, which help prevent bleeding. Threonine plays an important role in fat metabolism and your immune function, too. Tryptophan: Tryptophan helps maintain your body's correct nitrogen balance. It also helps make a brain chemical (neurotransmitter) called serotonin. Serotonin regulates your mood, appetite and sleep. Valine: Valine is involved in muscle growth, tissue regeneration and making energy. Your body produces the rest of the 11 amino acids you need. These are called nonessential amino acids. The nonessential amino acids are alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine and tyrosine. Some nonessential amino acids are classified as conditional. This means they're only considered essential when you're ill or stressed. Conditional amino acids include arginine, cysteine, glutamine, tyrosine, glycine, ornithine, proline and serine. Functions of Amino acids Functions of Essential Amino acids Phenylalanine helps in maintaining a healthy nervous system and in boosting memory power. Valine acts as an important component in promoting muscle growth. Threonine helps in promoting the functions of the immune system. Tryptophan is involved in the production of vitamin B3 and serotonin hormones. This serotonin hormone plays a vital role in maintaining our appetite, regulating sleep and boosting our moods. Isoleucine plays a vital role in the formation of haemoglobin, stimulating the pancreas to synthesize insulin, and transporting oxygen from the lungs to the various parts. Methionine is used in the treatment of kidney stones, maintaining healthy skin and also used in controlling invade of pathogenic bacteria. Leucine is involved in promoting protein synthesis and growth hormones. Lysine is necessary for promoting the formation of antibodies, hormones, and enzymes and in the development and fixation of calcium in bones. Histidine is involved in many enzymatic processes and in the synthesizing of both red blood cells (erythrocytes) and white blood cells (leukocytes). Functions of Non-Essential Amino acids Alanine functions by removing toxins from our body and in the production of glucose and other amino acids. Cysteine acts as an antioxidant and provides resistance to our body; it is important for making collagen. It affects the texture and elasticity of the skin Glutamine promotes a healthy brain function and is necessary for the synthesis of nucleic acids – DNA and RNA. Glycine is helpful in maintaining the proper cell growth, and its function, and it also plays a vital role in healing wounds. It acts as a neurotransmitter. Glutamic acid acts as a neurotransmitter and is mainly involved in the development and functioning of the human brain. Arginine helps in promoting the synthesis of proteins and hormones, detoxification in the kidneys, healing wounds, and maintaining a healthy immune system. Tyrosine plays a vital role in the production of the thyroid hormones -T3 and T4, in synthesizing a class of neurotransmitters and melanin, which are natural pigments found in our eyes, hair, and skin. Serine helps in promoting muscle growth and in the synthesis of immune system proteins. Asparagine is mainly involved in the transportation of nitrogen into our body cells, formations of purines and pyrimidine for the synthesis of DNA, the development of the nervous system and improving our body stamina. Aspartic acid plays a major role in metabolism and in promoting the synthesis of other amino acids. Proline is mainly involved in the repairing of the tissues in the formation of collagen, preventing the thickening and hardening of the walls of the arteries (arteriosclerosis) and in the regeneration of new skin. Market Segmentation Product type Insights Which Product Segment is Dominating the Amino Acid Market in 2024? The non-essential amino acids segment dominated the market in 2024, due to extensive usage in food additives, some dietary health supplements, and various pharmaceutical formulations. Amino acids such as glutamic acid and aspartic acid are extensively utilized in flavoring agents and other products for metabolically enhanced products. As they can be produced by the body, they are commercially viable for large scale production leading to common usage. The essential amino acids segment expected to grow significantly amino acid market during the forecast period, owing to increasing awareness of balanced nutrition and muscle health. Essential amino acids such as leucine, valine, and lysine play an important role in both sports nutrition and medical diets as they can't be produced by the body and have to be consumed from food or supplements. Source Type Insights Why is Plant-Based is the Leading Application Segment? The plant-based sources segment will dominate the market in 2024, still benefitting from expanding global trends of veganism and plant-based nutrition. Soy, peas, and other legumes yield large and efficient supplies of amino acids naturally and cleanly, and consumers are largely expecting their protein products to be natural and clean label. Plant-based production is also associated with lower environmental impact, helping explain why said manufacturers and consumers have favored these foods if reduced impact is a factor. Animal-based sources segment are expected to grow at fastest rate during the forecast period, with increased amino acid density and superior bioavailability. This category comprises amino acids harvested from meat, eggs, dairy, etc., and overwhelmingly utilized in clinical nutrition and infant formula. The increase in interest towards high-protein diets and the growing presence of functional food and therapeutic nutrition segments justify the strong growth in animal-based sources. Grade Type Insights How Pharma Grade Segment Dominate Amino Acid Market in 2024? The pharma-grade segment is the largest in 2024 owing to the critical role it plays in clinical formulations, metabolic therapies, and the medical nutrition market. Pharmaceutical-grade amino acids with the highest purity are administered to patients, via intravenous feeds, in chronic disease treatment, surgery, and to patients suffering from protein deficiency or impaired digestion. The segment is the most important to healthcare systems around the world due to the rigorous quality standards and regulatory approval. Feed-grade amino acids segment are predicted to grow the fastest rate during the forecast period, owing to their increased use in livestock and poultry nutrition. Products such as lysine, methionine, and threonine have been shown to aid with animal growth and feed efficiency and overall improve animal productivity. Furthermore, the global imperative to produce antibiotic-free meat as well as the rising importance of sustainability in farm animal production will drive the growth of amino acid-based feed additives. End User Insights Which End-User Segment Dominates the Amino Acid Market in 2024? The food and beverage segment led the market in 2024. This was due largely to a surge in consumer interest in functional foods and dietary supplements. Amino acids are used for flavor enhancement (like monosodium glutamate), nutrition enhancement, and as a texturizer. Amino acids have become more important in daily foods due to increasing demand for protein and wellness-focused diet trends. The pharmaceutical segment expects the fastest growth during the forecast period, as more applications for amino acids are becoming accepted in the medical market, such as metabolic disorder therapies, tissue repair, and chronic disease management. In addition, their use in intravenous nutrition is on the rise, especially with patients with chronic gastrointestinal disorders or recovering from surgery. The evolution of amino acid-based drug delivery systems and therapeutic formulations is also accelerating the growth of this segment. Invest in Premium Global Insights Immediate Delivery Available @ What Makes Asia Pacific a Global Amino Acid Leader? Asia Pacific dominated the amino acid market in 2024, which was fuelled by very significant capacity additions and pro-development policies. Adisseo's new methionine plant in Fujian province, China was commissioned in August 2023, which demonstrates the regional level of investment in feed-grade amino acids. On top of this, Google's collaborators have seen significant traction in the stake of fermentation-derived high-purity ingredients in the pharmaceutical and nutraceutical sectors due to increasing protein consumption and urbanization. This combination of major initiatives solidified the Asia-Pacific marketplace as the world's production hub supported by alternative protein research and governmental support. Market Trends China China continues to be at the very centre of Asia Pacific region dominance. The government's feed reform is a policy-driven effort to reduce the percentage of soymeal in animal feed to 10% (from 13%) by the year 2030, which has accelerated the adoption of synthetic amino acids by large farms in China. ) These trends further reinforce China's ability as the region's powerhouse where companies are broadening their capabilities in fermentation and bio-manufacturing to exploit the new demand. Is Europe's Regulatory Revolution Driving an Increased Demand for Amino Acids? Europe expects the fastest growth in the market during the forecast period. The demand for amino acids in Europe is witnessing a dynamic shift, largely influenced by much stricter regulations limiting the use of antibiotics in livestock. As the EU has an absolute prohibition on 'prophylactic' (preventative) and group level treatment with antibiotics. In the face of these regulations, farmers may be looking to amino acids, such as lysine and methionine, as alternatives to support animal health and performance. Major organisations such as BASF are already onboard with this movement, with facilities in Germany and Belgium producing amino acid intermediates from 100% renewable electricity and effectively reducing approximately 1.8 million tonnes of CO2 emissions per year. As new regulations combine with environmental responsibility, we are witnessing unprecedented market growth across the whole region. Germany Market Trends Germany is set to take advantage of this rapidly evolving landscape in terms of amino acids—we see a unique combination of industrial innovation and willingness to comply with regulations. BASF's Ludwigshafen plant has shifted its amino related intermediate production to an operation powered entirely by renewable energy. In terms of livestock, German farmers are increasingly reliant on amino acids to achieve productivity targets while adhering to strict EU regulations specifically aimed at antibiotics. More Insights in Towards Chem and Materials: Polyglycolic Acid Market : The global polyglycolic acid market size was estimated at USD 6.19 billion in 2024 and is predicted to increase from USD 6.79 billion in 2025 to approximately USD 15.72 billion by 2034, expanding at a CAGR of 9.77% from 2025 to 2034. Polymer Denture Material Market : The global polymer denture material market size accounted for USD 2.49 billion in 2025 and is forecasted to hit around USD 4.11 billion by 2034, representing a CAGR of 5.75% from 2025 to 2034. Polyethylene Wax Market : The global polyethylene wax market size was valued at USD 2.35 billion in 2024 and is expected to hit around USD 3.56 billion by 2034, growing at a CAGR of 4.25% from 2025 to 2034. Specialty Polymer Market : The global specialty polymer market volume was estimated at USD 17.71 million tons in 2024 and is predicted to increase from 19.25 million tons in 2025 to approximately 40.7 million tons by 2034, expanding at a CAGR of 8.67% from 2025 to 2034. Bio-Based Textiles Market : The global bio-based textiles market size reached a size of 54.21 billion in 2025, the market is further projected to grow at a CAGR of 8.55% between 2025 and 2034, reaching a size of 113.43 billion by 2034. Competitive Landscape in the Amino Acid Market Adisseo- Major producer of methionine for animal nutrition, particularly poultry and swine. ADM- Supplies soy-based amino acids and blends for food and feed industries. Ajinomoto Co., Inc.- Pioneer in industrial production of amino acids like glutamate and lysine via fermentation. AMINO GmbH- Specializes in high-purity amino acids for pharmaceuticals and biotech research. Bill Barr & Company- Distributes amino acids and related ingredients for food, feed, and pharma markets. DAESANG- Produces MSG, nucleotides, and amino acids like lysine via fermentation. DSM- Offers amino acid-based nutritional solutions for animal and human health. Donboo Amino Acid Co., Ltd.- Manufactures bulk essential amino acids (e.g., leucine, valine) for various industries. Evonik Industries AG- Leading global producer of DL-Methionine for animal nutrition. Fermentis Life Sciences- Produces fermentation-derived amino acids and peptides for food and pharma. Global Bio- Chem Technology Group Company Limited Produces corn-derived amino acids like glutamic acid and lysine at scale. IRIS BIOTECH GmbH- Supplies custom amino acid derivatives for drug delivery and peptide synthesis. What is Going Around the Globe? In January 2025, TRI-K Industries launched Fision® GlowPlex which is an amino acid ingredient for skin aids to increase radiance and even skin tone. TRI -K's sustainable innovation will represent both a functional and sustainable approach to a new class of active ingredients in cosmetics. In September 2024, Ajinomoto Co., Inc. and Danone launched a strategic partnership that aims to reduce greenhouse emissions in the dairy industry utilizing amino acid-based feed formulations to encourage a low-carbon food system. For more information, visit the Towards Chem and Materials website or email the team at sales@ +1 804 441 9344 Amino Acids Market Top Key Companies: Adisseo ADM Ajinomoto Co., Inc. AMINO GmbH Bill Barr & Company BI Nutraceuticals Blue Star Corp. CJ CheilJedang Corp. DAESANG DSM Donboo Amino Acid Co., Ltd. Evonik Industries AG Fermentis Life Sciences Global Bio-Chem Technology Group Company Limited IRIS BIOTECH GmbH KYOWA HAKKO BIO CO., LTD. Novus International PACIFIC RAINBOW INTERNATIONAL, INC. Sichuan Tongsheng Amino Acid Co., Ltd. Taiwan Amino Acid Co., Ltd. Sigma-Aldrich Wacker Chemie AG Wuxi Jinghai Amino Acid Co., Ltd. Wuhan Grand Hoyo Co., Ltd. Hebei Huayang Group Co., Ltd. Amino Acids Market Report Segmentation This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Towards Chem and Materials has segmented the global Amino Acids Market Type Outlook (Volume, Kilotons; Revenue, USD Million, 2020 - 2034) Essential Histidine Isoleucine Leucine Lysine Methionine Phenylalanine Threonine Tryptophan Valine Non-essential Alanine Arginine Asparagine Aspartic Acid Cysteine Glutamic Acid Glutamine Glycine Proline Serine Tyrosine Ornithine Citrulline Creatine Selenocysteine Taurine Others Source Outlook (Volume, Kilotons; Revenue, USD Million, 2020 - 2034) Plant-based Animal-based Chemical Synthesis Fermentation Grade Outlook (Volume, Kilotons; Revenue, USD Million, 2020 - 2034) Food Grade Feed Grade Pharma Grade Other Grades By Regional North America Europe Asia Pacific Latin America Middle East Africa Immediate Delivery Available | Buy This Premium Research Report@ About Us Towards Chem and Materials is a leading global consulting firm specializing in providing comprehensive and strategic research solutions across the chemical and materials industries. With a highly skilled and experienced consultant team, we offer a wide range of services designed to empower businesses with valuable insights and actionable recommendations. USA: +1 804 441 9344 APAC: +61 485 981 310 or +91 87933 22019 Europe: +44 7383 092 044 Email: sales@ Web: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Japan Times
08-07-2025
- Health
- Japan Times
Despite leadership changes Kobayashi Pharma still struggling with reform
Kobayashi Pharmaceutical remains only halfway through overhauling its corporate governance, as it struggles to restore public trust following the revelation of health problems linked to some of its dietary supplements more than a year ago. In an effort to move past its troubled legacy, the Osaka-based company has replaced its president twice and appointed an external chairman. These steps were intended to reduce the influence of the founding family, whose dominance has been widely seen as a root cause of the scandal. The family is believed to hold a 30% equity stake in the company and wields significant influence, posing a formidable barrier to meaningful internal reform efforts. In March last year, Kobayashi Pharmaceutical reported a series of health issues, including cases of kidney disease, among consumers who had taken dietary supplements containing beni kōji, rice fermented with red yeast. In response, the company has been compelled to review its management structure, compensate affected individuals and investigate the root cause of the problem. A report by an independent fact-finding committee comprising external attorneys concluded that then-President Akihiro Kobayashi "failed to take the lead on conducting a product recall or issuing a warning to ensure consumer safety." Following these findings, the company announced in July the same year that both Kobayashi and his father, Chairman Kazumasa Kobayashi, would resign from their positions. Satoshi Yamane, who was promoted from senior managing director to president the following month, described the company's corporate culture up to that point as one of "homogeneity" centered around the founding family. He noted that this culture had led to an overreliance on the Kobayashi family, and initiated efforts to reduce management's dependence on the family and foster a more diverse and resilient leadership structure. But in January this year, Yamane announced his resignation as president, with Executive Officer Norikazu Toyoda succeeding him. Additionally, three of the four outside directors decided to step down. As a result, five of the seven directors, including outside directors, who were in office when the beni kōji issue emerged have now left their positions. To further strengthen its leadership, Kobayashi Pharmaceutical has appointed Yoshihito Ota, known for his role in the management turnaround of Japan Airlines, as chairman following Toyoda's promotion to president. While the embattled company is highlighting progress in its management reforms, fully distancing itself from the founding family remains a significant challenge. Former Chairman Kazumasa Kobayashi continues to serve the company as a special adviser, while former President Akihiro Kobayashi now holds the position of director in charge of compensation. Oasis Management, a Hong Kong-based investment fund that owns 10% of Kobayashi Pharmaceutical's outstanding shares, has been critical of the company's management since last autumn. At an extraordinary shareholders' meeting in February, Oasis Management proposed its own slate of directors, but the proposal was rejected by a majority vote. In an unexpected turn of events in March, shareholders rejected a proposal by management to amend the company's articles of incorporation at the annual meeting. The proposed revision had been intended to advance governance reform. Currently, the articles of incorporation stipulate that the chairman and president serve as co-chairs of the board of directors. Management's proposal sought to change the provision so that, in principle, the chairmanship of the board would be held by an outside director. The proposal was rejected primarily because shareholders from the founding family voted against it, highlighting their significant influence over the company. In a recent interview, President Toyoda reflected on the outcome of the March general shareholders' meeting. He acknowledged, "We should have held more discussions to gain support from the founding family" regarding the proposed changes to the articles of incorporation. "The founding family also understands the importance of governance reform," he added. Toyoda expressed confidence that future internal reforms, compensation for victims and the implementation of measures to prevent a recurrence of the health issue would not be affected. In May, Kobayashi Pharmaceutical published its first newspaper advertisement since the scandal broke, and in June it resumed television commercials. With compensation for the victims still incomplete, however, consumer confidence in the company is still low. "We have yet to see whether (the resumption of commercials) will actually bring back customers," Toyoda said.

Associated Press
03-07-2025
- Health
- Associated Press
Global Kratom Coalition Applauds FDA Action Against Hydroxie and Expects Broader Crackdown Against Synthetic Opioids Like 7
FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health risk associated with the proliferation of 7 The Global Kratom Coalition (GKC) today commended the U.S. Food and Drug Administration (FDA) for issuing a comprehensive and forceful warning letter to Hydroxie, LLC, a seller of synthetic 7-hydroxymitragynine (otherwise known as '7') products falsely marketed as dietary supplements, shots, and drink mixes. The GKC hailed the move as a critical step in addressing these products that masquerade as natural dietary supplements but are actually unapproved new drugs. 'This warning letter is a major step in a broader effort to remove dangerous '7' products from store shelves and online marketplaces,' said Walker Gallman, Legislative Director of the Global Kratom Coalition. 'These actions should protect consumers and safeguard the integrity of the dietary supplement marketplace. It should result in a cascade of warnings to other 7 makers.' In the June 25, 2025, letter , the FDA identified multiple violations of the Food, Drug, and Cosmetic Act, citing Hydroxie's products as both unapproved new drugs and adulterated food. The FDA noted that Hydroxie's 7 products—including its 'Hydroxie 15mg 7-OH Tablets,' 'Hydroxie Red Shots,' and 'Hydroxie 7-OH Drink Mix"—are marketed with drug claims and contain an ingredient not generally recognized as safe. 'Your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets... are drugs as defined by section 201(g)(1) of the FD&C Act... because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,' the FDA stated in the letter. 'Based on our review... the use of 7-OH in conventional food does not satisfy the criteria for GRAS status... [and] raises serious concerns about potential harm associated with 7-OH,' the agency warned. 'This is a watershed moment,' said Gallman. 'The FDA has now publicly and definitively recognized that products like Hydroxie's, which are made up of synthetically boosted and highly concentrated levels of 7-hydroxymitragynine, are deceptively marketed as dietary supplements or conventional foods and are illegal. They are not kratom products; they are not dietary supplements; they are not legal; they are unapproved drugs and adulterated foods masquerading as legal, natural products.' FDA Warning Letter Addresses Persistent 'Bad Actors' Damaging Industry The GKC has long warned that certain actors in the marketplace are undermining public trust in the dietary supplement industry by selling synthetically enhanced or adulterated 7 products, often under the guise of 'all natural' or 'dietary supplement' or as 'kratom'. However, these products are marketed by the companies that sell them and the advocacy organizations that support them ( Holistic Alternate Recovery Trust (HART) and 7-Hope Alliance ) as drugs to treat chronic pain and opioid use disorder. The FDA's letter made clear that: 7 has not been evaluated by the FDA for safe use. Without formal safety evaluation, consumers are left exposed to unknown risks from products that have never undergone rigorous scientific review. The FDA has received adverse event reports associated with 7. Reports of harm linked to 7 include serious side effects such as liver toxicity, seizures, and respiratory issues, underscoring the need for immediate regulatory scrutiny. 7 has opioid-like effects and poses unique safety concerns. Because concentrated, synthetic 7 is a novel, potent opioid receptor agonist, its presence in unregulated consumer products raises red flags about addiction, misuse, and overdose. 'We urge the FDA and state regulators to continue down this path,' said Gallman. 'The longer these products are on the market, the greater the threat to public safety.' A Growing Chorus of Concern About Synthetic 7-Hydroxymitragynine Products The FDA warning letter also adds to a growing chorus of scientists, researchers, and industry stakeholders who have issued concerns about 7 products. In reaction to the FDA warning letter on social media, Dr. Christopher R. McCurdy, PhD, from the University of Florida College of Pharmacy said , 'The FDA is taking action on semi-synthetic kratom alkaloid derivatives, and this is exactly what we count on the FDA to do! These non-kratom products need to be removed from the market as they are no different from the many synthetic cannabinoids that made up 'spice' and caused harm to many … These novel chemicals synthesized from kratom extracts are potent opioids and a public health threat as currently marketed. They might be beneficial if pursued through the same pathways that all novel drugs gain approval.' In a statement released last week, Dr. C. Michael White, Pharm.D., FCP, FCCP, FASHP, a pharmacist, distinguished professor of pharmacy practice at the University of Connecticut School of Pharmacy, and Kratom Consumer Advisory Council chair said: 'Selling potent opioid receptor-stimulating 7 products in gas stations, convenience stores, and smoke shops in unlimited quantities within arm's reach of candy bars and energy drinks is a public health recipe for disaster. It allows a whole new generation of consumers to potentially get hooked on opioids, and we know where that leads.' In late 2024, leading kratom researchers at Johns Hopkins University and the University of Florida issued urgent warnings about proliferation of 7 products and for its potential for abuse, dependence, severe withdrawal , and even respiratory depression, dangers that run directly counter to it being marketed as a treatment for opioid addiction. GKC Committed to Transparency and Science The Global Kratom Coalition will continue to encourage and support federal and state regulators to investigate vendors who make false or misleading claims about their products, particularly those promoting unapproved drugs disguised as dietary supplements. About Global Kratom Coalition The Global Kratom Coalition is an alliance of kratom consumers, experts, and industry leaders dedicated to protecting access to kratom while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers. For more information, visit Media Contact Patrick George +1 916-202-1982 [email protected] ### SOURCE: Global Kratom Coalition Copyright 2025 EZ Newswire


Forbes
02-07-2025
- Health
- Forbes
MCT Oil: Science Backed Health Benefits And Uses
Medium-chain triglyceride (MCT) oil is a dietary supplement gaining attention for its potential health benefits, which may include supporting weight loss and enhancing metabolism, as well as brain health. In this article, we dive into MCT oil, including how it's sourced, potential benefits and drawbacks, and expert advice about product quality and dosing. Whether you're hearing about MCT oil for the first time or considering adding it to your wellness routine, we've got you covered. Dietary supplements are not regulated by the Food and Drug Administration (FDA), and ingredients and their amounts may vary. Be sure to talk to your doctor before taking any supplement. MCT oil is a concentrated form of medium-chain triglycerides, a type of fatty acid. It is available on its own or found in natural sources. '[MCTs] are fatty acids your body absorbs really fast,' says Jessica Peatross, M.D., a board-certified internist and functional medicine practitioner based in St. Petersburg, Florida. Compared to long-chain triglycerides (LCTs) found in most dietary fat sources—think avocadoes, meat, cheese, olive oil and nuts—MCTs are more easily digested and metabolized. MCTs head straight from your bloodstream to your liver, where they're converted into ketones (acids produced by the liver when fat is broken down for energy) or used as an immediate energy source, explains Dr. Peatross. Thanks to this quick conversion to energy, MCT oil is popular among individuals following ketogenic and low-carb diets , as it helps maintain ketosis—a metabolic state where the body burns fat instead of carbohydrates for energy. Fatty acids consist of a long chain of carbon atoms. The fundamental difference between MCTs and LCTs (both saturated fats) is their molecular structure. MCTs have a shorter fatty acid chain length: MCTs contain six to 12 carbon atoms, whereas LCTs contain more than 12 carbon atoms. Because LCTs have a longer chain length, they require bile salts and pancreatic enzymes for digestion, meaning they take longer to metabolize, says Dr. Peatross. Sources of MCT Oil Primary sources of MCT oil include coconuts, palm kernels and milk fat products like butter and ghee. Coconuts contain the highest concentration of MCTs among these sources (65%).. According to Dr. Peatross, MCT oil is a concentrate of the carbon atoms that are most efficient at turning into energy and ketones, including: Caproic acid (contains six carbon atoms) Caprylic acid (contains eight carbon atoms) Capric acid (contains 10 carbon atoms) Lauric acid (contains 12 carbon atoms) Coconut oil is often compared to MCT oil due to its high MCT content. However, MCT oil is a more concentrated source and can provide the benefits of MCTs without the additional calories and long-chain fatty acids found in coconut oil. Among the purported benefits of MCT oil, the following are backed by research. May Assist With Weight Loss The rapid metabolism of MCTs can increase how your body burns calories and how full you feel after eating, potentially leading to reduced calorie intake throughout the day. Numerous studies suggest that MCT oil may aid in weight loss. A 2024 meta-analysis in Clinical Nutrition concluded that among individuals with overweight and obesity, diets enriched with MCTs are more effective in achieving weight loss than diets that did not include MCTs. May Prevent Muscle Loss MCT oil may help maintain muscles by providing a readily available energy source, which is crucial for stimulating protein synthesis, says Angela Graham, a registered dietitian nutritionist and owner of The Dispersed Dietitian, a platform that combines nutrition coaching with the outdoors. This type of oil may be particularly helpful in preventing sarcopenia, the age-related loss of muscle mass and strength. A 2019 clinical trial in The American Journal of Clinical Nutrition found that consuming MCT oil improved muscle strength and function in older adults. Enhances Metabolism Because MCT oil is rapidly absorbed and converted to energy, it has a thermogenic effect (increased metabolic rate after eating) that can help maintain lean muscle mass during weight loss, explains Dr. Peatross. A 2023 study in the Journal of Translational Medicine examined the effects of MCT oil supplementation (20 grams daily for 45 days) among women with overweight or obesity on a very-low-calorie ketogenic diet. The supplemented group experienced significant decreases in body weight, body mass index (BMI) and waist circumference. Supports Cognition Ketones, a byproduct of MCT oil breakdown, easily cross the blood-brain barrier and can be used as an alternative fuel source to glucose. 'The keto (high-fat) diet is great for overall brain health or brain-specific conditions,' notes Dr. Peatross. For example, ketogenic diets rich in MCTs may support cognitive function in people with mild Alzheimer's disease , says Graham, as the condition impairs the body's ability to break down glucose for energy in the brain. Additional large-scale studies are needed to confirm the ways in which MCT oil can support cognition , according to researchers in the field. May Help Fight Infections MCTs possess natural antimicrobial and antifungal properties, says Dr. Peatross. Capric and caprylic acid, in particular, have shown efficacy against various pathogens, including Candida albicans, a common yeast that can cause infections. While MCT oil may have additional anti-inflammatory effects, more research is needed. Prevents Malnutrition in Digestive Disorders 'MCTs don't require bile acids for digestion, which makes them easier to absorb for people with digestive disorders like Crohn's, celiac disease or pancreatic insufficiency (where the pancreas doesn't produce enough enzymes to digest food),' says Graham. She adds that they're often used in clinical nutrition for patients who need extra calories in an easy-to-digest form. Fuel Your Day with Onnit MCT Oil! Unlock your potential with Onnit MCT Oil, the perfect addition to your daily routine. Packed with medium-chain triglycerides, Onnit's premium oil provides a quick source of energy and supports cognitive function. Shop Now On Onnit's Website While MCT oil has promising benefits, it's not without drawbacks. Excessive consumption of MCT oil can lead to fat accumulation in the liver, potentially increasing the risk of developing fatty liver disease. While most people feel less hungry when consuming MCTs, these fatty acids may increase ghrelin (a hunger hormone), especially when fasting, notes Dr. Peatross. MCT oils contain saturated fats, and high saturated fat intake may raise levels of low-density lipoprotein (LDL) cholesterol, often referred to as 'bad' cholesterol, causing plaque buildup in the arteries and potentially impairing cardiovascular health. MCT Oil Side Effects MCT oil is usually well-tolerated, but research suggests consuming too much may cause the following side effects: Nausea Vomiting Stomach and intestinal cramping Diarrhea Bloating MCT Oil Dosages No dosage recommendations exist for MCT oil, and working with a dietitian or health care professional can help you decide what may suit your unique needs. To minimize side effects, Graham recommends starting with a daily dose of one teaspoon and gradually increasing your intake to one to two tablespoons per day. 'You can blend [MCT oil] into smoothies [and] coffee , or drizzle it over oatmeal or veggies,' she says, adding that it's best not to heat the oil, which can cause it to break down and lose its beneficial properties. How to Choose the Best MCT Oil To choose a high-quality MCT oil, Dr. Peatross recommends considering the following: Source . Look for oils derived from organic, non-GMO and sustainably sourced coconut or palm kernel oil. . Look for oils derived from organic, non-GMO and sustainably sourced coconut or palm kernel oil. Purity . Choose a product free from additives, fillers and artificial ingredients that's packaged in glass or BPA-free bottles. . Choose a product free from additives, fillers and artificial ingredients that's packaged in glass or BPA-free bottles. Type of MCTs . Opt for oils that contain a higher concentration of caprylic acid and capric acid, as these are the most beneficial for energy production. . Opt for oils that contain a higher concentration of caprylic acid and capric acid, as these are the most beneficial for production. Third-Party Testing. Select products that undergo third-party laboratory testing for quality and potency to ensure you get a reliable product.


Reuters
23-06-2025
- Business
- Reuters
Court revives lawsuit against supplement maker, applies lower bar for mislabeling claims
June 23 (Reuters) - A U.S. appeals court revived a proposed class action against a dietary supplement company on Monday, ruling that a single test showing its product had a misleading nutrition label was enough for the case to move forward. The San Francisco-based 9th U.S. Circuit Court of Appeals reversed a lower court's ruling that had dismissed a lawsuit against ProSupps USA over claims that its Hydro BCAA product had far more carbohydrates and calories than the label listed. The appeals panel said, opens new tab the plaintiff, Jacob Scheibe, had enough initial evidence to accuse ProSupps of mislabeling its product under California law, rejecting the lower court's holding that Scheibe needed to use a more elaborate testing regimen set by the U.S. Food and Drug Administration. The ruling means that in the 9th Circuit, where district courts have issued varying rulings on product testing requirements for lawsuits alleging mislabeling under state law, it could become easier for consumers to bring such claims. The 9th Circuit said that in the initial phase of a lawsuit, a plaintiff doesn't have to follow the full FDA sampling process to accuse a company of using a false nutrition label. For labels on products fortified with protein and other nutrients like those sold by ProSupps, the FDA requires testing on 12 samples, each taken from different lots of product, a nearly impossible thing for an everyday customer to replicate, said Charles Weller, the attorney for the plaintiff. Until now, some courts in the 9th Circuit were requiring it before a mislabeling lawsuit could be filed, he said. Representatives for ProSupps did not immediately respond to requests for comment. Customer Jacob Scheibe filed the proposed class action against the company in 2022, claiming that the label on the Hydro BCAA powdered supplement said they contained zero carbohydrates and zero calories, but a test using an FDA-prescribed process showed the product had more than five grams of carbohydrates and more than 50 calories per serving. He brought claims under California's consumer deception laws on behalf of a class of California ProSupps customers. The trial court dismissed the lawsuit, agreeing with ProSupps that Scheibe needed to use the 12-sample method to avoid having his claims preempted by federal labeling law. In its ruling reversing the lower court, the appellate court said Scheibe's one test of the product and the results that showed a significant difference from what the label read were enough to allow an inference that more testing would also show the label was wrong. The case is Scheibe v. ProSupps USA LLC, U.S. Court of Appeals for the 9th Circuit, No. 23-3300 For the plaintiffs: Charles Weller For ProSupps: Jessica Walker of Theodora Oringher; and Jaikaran Singh of Foley & Lardner