By Pat Anson

The Food and Drug Administration is cracking down again on the kratom industry, by sending warning letters to 7 kratom vendors about illegally marketing a dietary supplement.

At issue is an alkaloid in kratom called 7-hydroxymitragynine — known as 7-OH — which relieves pain, improves mood, increases energy, and has opioid-like properties. 7-OH occurs naturally in kratom, but is present in only trace amounts.

Too boost its potency, some vendors are selling kratom gummies, tablets and extracts with concentrated levels of 7-OH, which the FDA says “may be dangerous.”

“7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,” the agency said in a press release.         

Warning letters were sent this month to Shaman Botanicals, My Smoke Wholesale, Relax Relief Rejuvenate Trading, Thang Botanicals, Royal Diamond Imports, Hydroxie, and 7Tabz Retail. The companies were given 15 business days to respond or take corrective action.

While some of the vendors have removed 7-OH products from their websites, others continue to sell them. Hydroxie, for example, still accepts orders for chewable tablets containing up to 30mg of 7-OH on its website. There are no explicit warnings about the tablets on the webpages where they are advertised, but Hydroxie cautions consumers about 7-OH on its “Warnings” page.     

“This product contains concentrated alkaloids. The potency is significantly greater than raw leaf,” Hydroxie says. “Levels of 7-OH in these tablets are extremely concentrated. Do not use this product without first consulting a doctor about this alkaloid to ensure it is safe for you.”

Kratom has been used for centuries in southeast Asia as a natural stimulant and pain reliever, but only in the past decade has it become widely available in the United States. It’s rare for someone to have an adverse reaction to natural kratom leaf, but people who consume concentrated extracts have been hospitalized or experienced overdoses.

Recently, former CDC Commissioner Robert Redfield, MD, called for kratom products containing elevated levels of 7-OH to be taken off the market.

“What we’re seeing with the compound 7-hydroxymitragynine is a textbook case of how manufacturers exploit regulatory gaps to create products that are, in essence, unregulated pharmaceuticals,” Redfield said.

“To put this in perspective: natural kratom contains less than 0.01 percent 7-hydroxymitragynine. These synthetic products contain concentrations up to 150 times higher. This is not botanical kratom — this is pharmaceutical-grade opioid chemistry operating without oversight.”

Two deaths and three other serious cases involving 7-OH mitragynine have been reported on the FDA’s Adverse Events Reporting System since 2023.  Of the three adverse events reported so far in 2025, one was considered life threatening. Another case resulted in a person being hospitalized. No other details are available.

When used cautiously, kratom advocates say 7-OH is a highly effective pain reliever and safer alternative to opioid medication.

“7-OH can be an invaluable harm reduction tool that should remain an option for the hundreds of thousands of consumers that rely on it,” the Holistic Alterative Recovery Trust (HART) said in a statement.

“HART strongly supports robust regulation and is pursuing legislation federally, and in the states, to mandate that all 7-OH products are manufactured safely, are marketed transparently, and are kept out of the hands of children.”    

The U.S. liposomal vitamins and minerals market is witnessing a significant surge as consumers increasingly prioritize health, wellness, and advanced nutritional supplementation. Valued at US$ 122.9 Mn in 2023, the market is projected to grow at a robust CAGR of 7.6% and exceed US$ 271.8 Mn by 2034, according to recent industry analysis. This growth is driven by factors such as the aging population, heightened health awareness, technological innovations in supplement delivery, and increasing adoption of liposomal formulations.

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Liposomal Technology Revolutionizing Nutrient Delivery

At the heart of this market’s rapid expansion lies the unique liposomal encapsulation technology, which enhances the bioavailability of vitamins and minerals. Liposomes are microscopic vesicles composed of phospholipid bilayers that mimic human cell membranes, allowing nutrients to be delivered more efficiently into the bloodstream.

Unlike traditional supplements, which often suffer from low absorption rates due to degradation in the digestive system, liposomal vitamins and minerals bypass many of these barriers. This results in significantly higher absorption and utilization by the body, making liposomal formulations a preferred choice for both consumers and healthcare providers.

Notably, liposomal technology is now being applied to a wide range of nutrients including vitamin C, vitamin D3, vitamin B12, iron, magnesium, zinc, glutathione, collagen, and curcumin, among others.

Technological Advancements Drive Market Growth

Modern manufacturing techniques such as microfluidization, thin-film hydration, and reverse-phase evaporation have improved the stability, precision, and efficacy of liposomal supplements. Recent innovations have even enabled the creation of nano-liposomes and smart liposomes-engineered to release nutrients in response to environmental stimuli like pH or temperature.

Such advancements allow targeted delivery of nutrients to specific tissues or cells, enhancing their therapeutic effect. As personalized nutrition becomes a key trend in the wellness industry, the role of these advanced delivery systems is becoming increasingly pivotal.

Rising Health Consciousness and Nutritional Awareness

The U.S. is experiencing a significant shift toward proactive health management, with consumers seeking ways to prevent chronic conditions through dietary and lifestyle choices. According to the CDC, nearly 13% of U.S. adults consume four or more dietary supplements monthly-indicative of a growing reliance on supplemental nutrition.

Several factors have fueled this trend:

Depleted soil quality and pesticide use reducing the nutritional content of food

Lifestyle-induced deficiencies due to poor diets, stress, or aging

Increased focus on immune health post-pandemic

Consumers are now looking for potent, fast-absorbing, and science-backed supplements, which has amplified the demand for liposomal products that promise superior efficacy.

Vitamins Dominate Product Segment

Among product types, liposomal vitamins hold a dominant market share, particularly vitamin C, vitamin D3 & K2 combinations, and vitamin B12. These are widely recognized for their roles in immune support, bone health, and energy metabolism.

Traditional vitamin C supplements have an absorption rate of just 14-30%, while liposomal vitamin C has demonstrated significantly higher absorption, making it one of the most popular liposomal supplements in the U.S. market.

As awareness of nutrient deficiencies grows-especially in aging adults and high-stress populations-demand for liposomal vitamin formulations is expected to remain high throughout the forecast period.

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Liquid Formulations Lead by Convenience and Compliance

Based on formulation, the liquid segment dominates the U.S. liposomal vitamins and minerals market. Liquids are easier to consume and digest, particularly for children, seniors, and individuals with swallowing difficulties.

Advantages of liquid formulations include:

Customizable dosing

Faster absorption

User-friendly administration

Their palatable flavors and convenience make liquid liposomal supplements particularly popular among new adopters and repeat consumers alike.

Offline Sales Channels Retain Market Majority

Despite the digitalization of healthcare retail, offline channels-especially supermarkets, hypermarkets, and retail drug stores-continue to lead in terms of sales volume. The personalized shopping experience, ability to consult store staff, and visibility of branded products contribute to the dominance of offline distribution.

However, online channels, including company-owned websites and third-party aggregators, are growing rapidly. The convenience of subscription models, doorstep delivery, and promotional offers make digital platforms a significant growth avenue, particularly among younger, tech-savvy consumers.

Competitive Landscape: Innovation and Retail Partnerships

The U.S. liposomal vitamins and minerals market is highly competitive, with companies investing in product innovation, retail partnerships, and consumer education. Key players include:

Codeage LLC

ActiNovo

Life Cykel Labs LLC

Goldman Laboratories LTD

LivOn Labs

Core Med Science

Quicksilver Scientific, Inc.

CYMBIOTIKA LLC

California Gold Nutrition

KAL Vitamins

Nutra Biogenesis

BodyBio

DaVinci Laboratories

Notable Developments:

July 2024: Quicksilver Scientific launched a new Cacao Mint flavor of its liposomal glutathione, expanding its popular antioxidant product line.

March 2024: Codeage LLC introduced its Liposomal Glutathione Powder, offering 1000 mg of glutathione per serving, with enhanced antioxidant and skin health benefits.

March 2024: CYMBIOTIKA entered a retail agreement with Sprouts Farmers Market, ensuring shelf presence across multiple physical stores in the U.S., thus expanding consumer access to premium liposomal supplements.

These strategic moves underscore how flavor innovation, product differentiation, and distribution expansion are central to competitive advantage in this rapidly evolving market.

Outlook: A Healthy Future for Liposomal Supplements

The U.S. liposomal vitamins and minerals market is expected to maintain its upward trajectory through 2034, supported by:

Aging demographics seeking bioavailable supplements

Rising healthcare costs pushing preventive health solutions

Technological advancements in delivery mechanisms

Strong retail and online distribution networks

Increased consumer education and wellness culture

As nutritional science continues to intersect with biotechnology, liposomal formulations are likely to redefine how Americans approach daily supplementation-providing higher efficacy, faster results, and greater trust in health outcomes.

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