This article follows on from Chapter 1: 2025 FSMP Industry Trends, where we explored the global outlook, regulatory milestones, and policy drivers shaping the FSMP sector. In this second chapter, we look more closely at how the concept of medicine-food homology is influencing product innovation, clinical applications, and market opportunities.

From Treatment to Full‐Cycle Health Management

Across Europe and Asia, the health industry is shifting from a focus on treating disease to managing health across the entire life cycle. Within this context, the traditional Chinese principle of medicine-food homology, the idea that food can also serve as medicine, has gained renewed relevance.寻找口服营养补充剂图片

Combined with advances in modern medicine and nutrition science, this philosophy has evolved into a specialised field: Foods for Special Medical Purpose (FSMP). These products are designed with targeted formulations to provide nutritional therapy for people with specific medical conditions.

When the Eastern wisdom of “food as medicine” meets the Western science of “precision nutrition,” the result is more than just new product formats. It represents a restructuring of both theory and practice, offering safe and effective solutions for chronic disease management, clinical recovery, and preventive care.

FSMP: A Precision Tool in Clinical Nutrition

FSMP are not ordinary foods. They are evidence‐based nutritional solutions developed for people with restricted intake, impaired digestion, metabolic disorders, or disease‐specific needs.

For example, post‐surgical patients with swallowing difficulties can benefit from liquid or peptide‐based FSMP that are absorbed efficiently while reducing intestinal strain. Unlike health supplements or pharmaceuticals, FSMP do not rely on pharmacological effects. Instead, they deliver nutritional therapy to support recovery and improve outcomes.

The concept originated in Western clinical practice. In the 1960s, the United States introduced enteral nutrition formulas for post‐surgical patients. By the 1980s, formulations had diversified into whole‐protein, peptide‐based, and amino acid‐based types.

China entered the field later, establishing a dedicated regulatory framework in 2016. Since then, more than 150 FSMP products have been approved, though this still lags behind the thousands available in Europe and the US, highlighting the sector’s growth potential.

Six Key Application Areas

FSMP are designed to meet precise nutritional needs across different life stages and health conditions.ce15bd89056fd7adecb27f39b69e7e11

Perioperative recovery: Peptide‐based enteral nutrition reduces infection risk and accelerates healing after gastrointestinal surgery.

Metabolic disease management: Specialised formulas for diabetes (slow‐release carbohydrates) and chronic kidney disease.

Oncology support: High‐energy formulas prevent cachexia, while omega‐3 enriched immune formulas improve quality of life and reduce complications.

Special infant nutrition: Hydrolysed protein or amino acid formulas for allergy management; preterm formulas with high energy density and lactoferrin.

Elderly frailty: Thickened liquid formulas reduce aspiration risk and help prevent sarcopenia, lowering malnutrition rates by up to 30 percent.

Inherited metabolic disorders: Low‐phenylalanine formulas for PKU patients to prevent neurological damage.

From Basic Support to Precision Function

The FSMP product landscape is evolving from basic nutrition support to precision functional interventions, covering all ages and multiple disease areas.

Age‐specific formulas range from infant anti‐allergy and lactose‐free products to adult full‐nutrition and disease‐specific formulations, such as resistant starch for diabetes or branched‐chain amino acids for liver disease.

New dosage forms are also emerging. Beyond traditional liquids, formats now include ready‐to‐drink bottles, instant powders, gels, and fibre‐enriched suspensions to improve compliance and gut health.

Medicine-Food Homology:

Traditional Wisdom Meets Modern Science

Integrating traditional functional ingredients into FSMP is opening new therapeutic pathways.

In metabolic diseases, blends of stevia, monk fruit glycosides, and hyaluronic acid have been shown in animal models to reduce blood glucose and lipid levels. In oncology, ginsenoside Rh2 and maitake polysaccharides enhance immune function and survival rates in cancer patients. In liver repair, silymarin and glutamine combinations improve mitochondrial function and reduce ALT/AST levels in alcoholic liver disease.

This marks a shift from empirical herbal pairings to scientifically validated ingredient-target-pathway mechanisms, supported by advanced extraction methods, molecular docking, and clinical trials.

Market Opportunities in China

Chronic diseases and ageing are the twin engines of growth. Over 300 million Chinese live with diabetes, chronic kidney disease, or cancer, yet only 30 percent receive standardised nutrition therapy. If FSMP penetration rises from under 2 percent to 10 percent, the market could exceed RMB 20 billion.

Since 2016, registration cycles have shortened, insurance reimbursement has expanded, and R&D subsidies have been introduced, all of which are accelerating adoption.

Challenges and the Path Forward

Despite strong momentum, FSMP faces several challenges.

Research and development requires high investment, with costs of 30 to 50 million RMB per formula, long clinical trials, and continued reliance on imported raw materials. Market awareness remains low: 72 percent of the public mistake FSMP for “premium health foods,” while only 18 percent know they require physician guidance. Competition is also intense. Multinationals dominate 65 percent of the market, but local firms are leveraging medicine-food homology to differentiate and catch up.

Conclusion

The convergence of medicine-food homology and FSMP represents a meaningful dialogue between traditional wellness wisdom and modern nutrition science. As preventive care merges with precision nutrition, a full‐cycle health management model is taking shape, spanning prevention, treatment, and rehabilitation.

While challenges remain in technology, awareness, and competition, policy support, consumer upgrading, and domestic innovation are driving momentum. This fusion of tradition and modernity is set to become a core force in advancing public health and unlocking the potential of a 150 billion RMB market.

References

IJBM | Wenzhou University Sun Da Research Group: Developing Potential Medicine-Food Homology FSMP Formulas for Diabetes Management, Food Plus Smart Food Tech.

Professor Yu Kang, Peking Union Medical College: Current Applications and Clinical Value of FSMP, Nutrition Science & Technology.

Popular Science | Special Foods: FSMP (Part III), SMO Food Testing.

FSMP Industry Market Analysis, National Dairy Engineering Technology Research Center.

Sinofn Health Co., Ltd.

Address

Room 704, Building 1 Minghai Center, 416 Hulunbeier Road, Dongjiang Area, Tianjin pilot Free Trade Zone, Tianjin, China

E-mail

sihuizhu@sinofn.com

Website

www.sinofnhealth.com

SINOFN Health Co., Ltd. is the dedicated supplement OEM manufacturing division of SINOFN Group – a national high-tech enterprise founded in 2012 and backed by the Chinese Academy of Sciences. Established in 2025, we operate from Shanghai as the trading hub for global partners seeking premium, science-driven contract manufacturing services.

This release was published on openPR.

Market data shows that in 2023 the global vitamin B9 (folic acid) market was approximately USD 118 million, and is expected to grow to USD 160 million by 2030, with a compound annual growth rate (CAGR) of 5.1%. China, as the world’s primary producer of folic acid, accounts for around 90% of global capacity. Its mature industrial chain and rich resources support broad applications across food and beverage, dietary supplements, pharmaceuticals, and animal feed.

This landscape is turning industry attention toward medicine, food homology ingredients: how to leverage modern food processes and technologies to scientifically develop raw materials rich in natural folate, and transform them into daily friendly, palatable, and efficacy‐driven natural folate nourishing products. The following explores innovation paths for developing food‐based supplements centered on natural folate from medicine food homology ingredients.

The truth about folate supplementation:

Differentiated needs and market opportunities

Folic acid, also known as vitamin B9, is a water‐soluble vitamin essential to human health. It plays a key role in cell division, DNA synthesis, anemia prevention, fetal development, and cardiovascular health.

People typically supplement folate in two ways: through daily foods (natural folate intake), or through folate‐related supplements, which suit preconception and pregnant women and those needing rapid replenishment, for example:

Preventing birth defects: Adequate folate intake reduces the risk of fetal neural tube defects (e.g., spina bifida, anencephaly). Because the neural tube closes very early in pregnancy (often before a woman realizes she is pregnant), folate supplementation must begin in advance.

Preventing anemia: Folate is required for healthy red blood cell production. Deficiency impairs maturation, leading to megaloblastic anemia with symptoms such as fatigue, weakness, and pallor.

Cardiovascular benefits: Folate helps convert homocysteine in the blood into other beneficial compounds. Elevated homocysteine is an independent risk factor for cardiovascular disease, associated with arterial damage and increased thrombosis risk.

Folate supplements tailored for pregnancy, anemia, and older adults Source: TaobaoImage: Folate supplements tailored for pregnancy, anemia, and older adults Source: Taobao

As an essential micronutrient, folate cannot be synthesized by the body and must be obtained through diet. By source, it is generally divided into natural folate and synthetic folic acid, which differ in structure, absorption mechanisms, and stability.

Natural folate is abundant in leafy greens, citrus fruits, and legumes, and integrates readily into human metabolic pathways. However, it is less stable and prone to degradation during cooking due to heat, light, pH, and metal ions. Rational preparation methods help preserve its activity in daily diets.

Synthetic folic acid is widely used in supplements and fortified foods. Compared with natural folate, it is more stable and relatively more bioavailable, yet may pose metabolic risks. For women planning pregnancy and those who are pregnant, supplements remain a reliable way to ensure adequate intake.

Folic AcidImage source: Internet

Important misconceptions persist:

Different groups need different daily amounts:

Adults: 400 μg/day

Preconception women: 400-800 μg/day

Pregnant women: 600-800 μg/day

Lactation: ~500 μg/day

High‐risk conditions: Up to 5 mg/day under medical supervision

Some individuals have folate metabolism barriers: Factors include limited MTHFR enzyme activity, malabsorption, drug interactions, liver disease, and inadequate dietary intake. These individuals struggle to convert standard folic acid into the active form (5‐methyltetrahydrofolate, 5‐MTHF), and may require already‐activated folate supplements.

640 (1)Image source: Internet

Additionally, certain habits and medications affect folate absorption and utilization, such as chronic alcohol intake and some antiepileptic drugs or antibiotics.

Folate supplementation is therefore not “one size fits all.” It involves specific needs by population, individual differences, and potential risks. Yet today’s market still primarily features synthetic folic acid products, whose metabolic limitations contrast sharply with consumers’ growing demand for “natural, safe, and personalized” health solutions. The market urgently needs folate strategies that are safe, effective, and precisely matched to different population needs.

Medicine-food homology:

Hidden treasury of natural folate

Previous research suggests the most impactful measure is “total folate,” including natural folate from foods and folic acid from fortified foods and dietary supplements. Because natural folate is water‐soluble and does not remain long in the body, it requires continuous dietary replenishment.

Beyond common sources such as spinach, asparagus, avocado, animal liver, and legumes, many medicine-food homology ingredients are rich in natural folate, offering traditional health functions while serving as important folate sources:

Goji berry (Lycium barbarum)

Folate content: Up to 1,400 μg per 100 g (dry), with ~70% bioavailability, exceeding typical leafy greens.

Traditional functions: Neutral and sweet in nature; enters liver and kidney meridians; nourishes kidney and liver, benefits essence and eyesight, and supports qi and blood.

Nutritional synergy: Folate and iron directly participate in hemoglobin synthesis; polysaccharides support immune modulation.

Formulation tip: Pair with vitamin C-rich foods (e.g., lemon) to develop composite nutrition products that improve folate absorption.

Goji berryImage source: Internet

Black sesame

Folate content: ~191 μg per 100 g. Also rich in essential amino acids, iron, vitamin E, and unsaturated fatty acids.

Potential benefits: Supports metabolism, helps prevent anemia, activates brain cells, and may help lower cholesterol.

Traditional functions: “Tonifies liver and kidney, benefits essence and blood.” Often combined with black rice; suitable for composite products targeting liver-kidney insufficiency and essence-blood deficiency.

Black sesameImage source: Internet

Euryale seed (Gorgon fruit)

Folate content: ~18 μg per 100 g (lower), but provides vitamin E, minerals, and easily absorbed small‐granule starch – suitable for pregnant/postpartum women and those with weak digestion.

Traditional functions: Tonifies the middle and qi, nourishes essence, strengthens will.

Bioactive compounds: Flavonoids, cyclopeptides, and glucosteroids with antioxidant, antibacterial, and anti‐myocardial ischemia effects.

Pairing: Often combined with malt, hawthorn, and yam to promote digestion, enhance immunity, and aid glycemic modulation.

Euryale seed (Gorgon fruit)Image source: Internet

Lotus seed

Folate content: Dry seeds ~45-60 μg per 100 g; lotus embryo (heart) higher (80-90 μg), though bitter; de‐embryo lotus commonly used (~40-50 μg).

Bioavailability: Predominantly bound folate (>65%), with ~68% bioavailability; slow release during digestion, less susceptible to gastric acid – well suited for folate supplementation in those with sensitive stomachs.

Lotus seedImage source: Internet

Hawthorn

Folate content: Dried ~20-35 μg per 100 g; fresh 8-12 μg.

Thermal stability: After 60°C drying or 100°C boiling for 30 minutes, folate retention exceeds 75%, far higher than spinach (under 50% with similar processing).

Application advantage: Ideal for products requiring thermal processing.

HawthornImage source: Internet

Taken together, medicine-food homology ingredients such as goji, black sesame, euryale seed, lotus seed, and hawthorn not only provide accessible natural folate but also deliver diverse bioactive compounds and traditional health functions – offering strong potential for development and complementary applications.

How natural folate fits “three core populations”:

Formulation innovation

With higher safety and metabolism‐aligned bioavailability, natural folate – under the medicine-food homology concept – has formed differentiated product matrices for three core groups: pregnant/postpartum women and infants, middle‐aged and older adults, and the general health market.

Physiological differences drive precision in ingredient pairing and process design, avoiding potential risks of synthetic folic acid while amplifying nutritional synergy through composite formulations.

Pregnant/postpartum women and infants:

High safety + precise nutrition

Goji berry: High folate + iron can be paired with gentle ingredients (e.g., yam, jujube) to develop postpartum qi-blood conditioning drinks or pastes, reducing reliance on synthetic iron and folic acid supplements.

Lotus seed: Bound folate is gentle and less irritating to sensitive gastrointestinal tracts; can be milled into powder for infant nutritional rice cereals or pregnancy meal replacements, delivering folate while supporting calming and spleen‐strengthening traditional effects.

Black sesame: Rich in folate, unsaturated fatty acids, and calcium – ideal for late‐pregnancy and lactation snacks (e.g., sesame balls, cookies), efficiently covering critical nutrients.

Black sesame cookiesImage source: TMall

Middle‐aged and older adults:

Chronic disease prevention + functional synergy

Cardiovascular support: Products add natural folate‐rich extracts alongside antioxidants such as coenzyme Q10 to help reduce homocysteine levels and lower cardiovascular risk.

Antioxidant formulations: Natural folate paired with vitamin E and selenium to counteract oxidative damage from multiple angles and support systemic function.

Neuroprotection: Natural folate, B6, and B12 jointly metabolize homocysteine, reducing neurotoxicity and potentially lowering dementia risk; may also improve sleep and memory in adults over 60 facing cognitive decline.

Hawthorn: Combines heat‐stable folate with traditional lipid‐lowering and blood‐invigorating functions; can be formulated with astragalus and ginseng into solid beverages or tablets for targeted lipid modulation.

Herbal TeaImage source: TMALL

Goji + black sesame synergy: Goji polysaccharides with black sesame’s vitamin E and selenium form robust antioxidant combinations for formulas aimed at healthy aging and cognitive maintenance – aligned with the holistic perspective of medicine-food homology.

General health market:

Everyday scenarios + easy supplementation

Convenient formats: Snacks: Single‐serve packs of black sesame and goji, or energy bars, deliver traditional wisdom in modern convenient forms. Drinks: Hawthorn + goji blends create flavorful wellness teas with clear benefits (“appetite‐opening,” “eye health”) and natural folate replenishment.

Functional beverages: Combine juices rich in natural folate (e.g., orange) with other nutrients in balanced ratios to help consumers top up folate in daily hydration.

Fortified basics: Add euryale and lotus seed powders to breakfast cereals or meal‐replacement mixes to supplement folate while supporting intestinal motility – meeting “light wellness” preferences.

Conclusion

With the core advantages of “low overdose risk, high bioavailability, and metabolism alignment,” natural folate – empowered by medicine-food homology – has moved beyond the scope of a single nutrient to become a vital bridge between traditional wellness and modern nutrition science.

From uncovering folate features in hawthorn and lotus seed to designing products tailored to pregnant/postpartum women and older adults, natural folate is reshaping supplementation into a natural part of daily eating. Looking ahead, as AI‐assisted formulation and cold‐chain upgrades advance, natural folate will integrate more precisely into everyday diets, standardize ingredient cultivation, and deliver full‐cycle health support across populations – driving nutrition consumption toward scientific, diversified upgrades.

References

Xu Tianyue, Zhang Junjie, et al. Progress in forms, stability, and naturalization of folate (vitamin B9). DOI: 10.19812/j.cnki.jfsq11-5956/ts.2024.02.029

Tan Mei. Enrichment and stability of natural folate/VB6 in Lactobacillus plantarum-fermented purple cabbage juice and mechanisms of action on the gut microbiota. Jinan University thesis.

Qin Shuyong. Questions and answers on folate supplementation: Scientific supplementation to safeguard health. Proceedings of the 2025 South China Health Management Forum – Health Science Popularization Collection.

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Sinofn Health Co., Ltd.

Address

Room 704, Building 1 Minghai Center, 416 Hulunbeier Road, Dongjiang Area, Tianjin pilot Free Trade Zone, Tianjin, China

E-mail

sihuizhu@sinofn.com

Website

www.sinofnhealth.com

SINOFN Health Co., Ltd. is the dedicated supplement OEM manufacturing division of SINOFN Group – a national high-tech enterprise founded in 2012 and backed by the Chinese Academy of Sciences. Established in 2025, we operate from Shanghai as the trading hub for global partners seeking premium, science-driven contract manufacturing services.

This release was published on openPR.

Introduction to java burn review

In the ever-evolving world of weight management supplements, Java Burn has emerged as a revolutionary approach to metabolic enhancement. As we navigate through 2025, the search for effective, natural solutions for weight management continues to grow, and our comprehensive java burn review aims to provide you with the most current and honest assessment of this popular coffee-based supplement. Unlike traditional weight loss products that require drastic lifestyle changes, Java Burn offers a simple integration into your daily routine by mixing with your morning coffee.

What sets Java Burn apart in the crowded supplement market is its unique delivery system and scientifically-backed ingredient profile. Our java burn coffee reviews analysis reveals that this tasteless, odorless powder contains a proprietary blend of natural metabolism-boosting compounds designed to work synergistically with caffeine. When combined with your regular coffee, it transforms your daily ritual into a powerful metabolic trigger that can help accelerate fat burning throughout the day.

Key Benefits and Features

After extensive research and analysis of numerous java burn reviews consumer reports, we’ve identified several key benefits that users consistently report experiencing:

Metabolic Acceleration

The primary mechanism of Java Burn revolves around enhancing your body’s natural metabolic rate. The formula contains ingredients like Chromium, L-Theanine, and L-Carnitine, which work together to optimize how your body processes energy. Unlike stimulant-based weight loss products that can cause jitters, Java Burn promotes a smooth, sustained metabolic boost that doesn’t overwhelm your system.

Appetite Regulation

Many java burn reviews 2025 highlight the product’s ability to naturally curb cravings and reduce overall calorie intake. The combination of ingredients helps stabilize blood sugar levels, which in turn minimizes sudden hunger pangs and reduces the tendency to snack between meals. This makes it easier to maintain a calorie deficit without feeling constantly deprived or hungry.

Energy Enhancement Without Crash

Traditional energy supplements often provide a quick burst followed by an inevitable crash. Java Burn’s formulation, particularly with the inclusion of L-Theanine, creates a balanced energy release that sustains throughout the day. Users report feeling more alert and focused without the nervous energy or subsequent fatigue associated with other metabolic enhancers.

Convenience and Simplicity

One of the most praised aspects in java burn reviews is the effortless integration into existing routines. There’s no need for complicated dosing schedules or special preparations—simply mix one packet with your morning coffee and continue with your day. This simplicity significantly increases compliance rates compared to more complex supplement regimens.

How to Get Started with Java Burn

Implementing Java Burn into your wellness routine requires minimal effort but following some best practices can optimize your results. Based on our analysis of successful user experiences from various java burn reviews consumer reports, we recommend this straightforward approach:

1. Consistent Morning Routine: Add one packet of Java Burn to your first cup of coffee each morning. Consistency is crucial for maintaining metabolic benefits throughout the day.
2. Proper Hydration: Drink adequate water throughout the day to support metabolic processes and help your body efficiently utilize the ingredients.
3. Balanced Nutrition: While Java Burn can enhance results, it works most effectively when combined with a sensible diet rich in whole foods.
4. Regular Activity: Incorporate light to moderate physical activity to complement the metabolic benefits of the supplement.
5. Patience and Tracking: Allow 2-3 weeks for your body to adjust and begin showing noticeable results. Track your progress with measurements beyond just scale weight.

Advanced Tips and Strategies for Optimal Results

For those looking to maximize their Java Burn experience, our analysis of long-term user java burn reviews 2025 reveals several advanced strategies:

Timing and Synergy

While Java Burn is effective with your first morning coffee, some users report enhanced benefits when timing their consumption approximately 30 minutes before physical activity. This allows the metabolic-enhancing compounds to reach peak effectiveness during exercise, potentially increasing fat utilization as an energy source.

Dietary Synergism

Pairing Java Burn with a moderately reduced carbohydrate intake appears to amplify its effects. The metabolic optimization seems to work particularly well when your body is encouraged to utilize fat stores more efficiently. However, extreme dietary restrictions are unnecessary and may counterproductively slow metabolism.

Cycling Protocol

Some experienced users mentioned in java burn coffee reviews implement a cycling strategy—using the product consistently for 8-12 weeks followed by a 2-4 week break. This approach may help maintain sensitivity to the ingredients and prevent adaptation that could diminish effectiveness over extended continuous use.

Common Mistakes to Avoid

Based on critical analysis of less successful experiences in java burn reviews consumer reports, we’ve identified several common pitfalls that can compromise results:

• Inconsistent Use: Skipping days or irregular usage disrupts the metabolic optimization process. Consistency is key to experiencing the full benefits.
• Overconsumption of Coffee: Adding Java Burn to excessive amounts of coffee (beyond your normal tolerance) can lead to discomfort. Stick to your regular coffee routine.
• Unrealistic Expectations: Java Burn is a metabolic enhancer, not a miracle cure. It works best as part of a comprehensive wellness approach.
• Neglecting Other Health Factors: Poor sleep, extreme stress, and inadequate nutrition can undermine Java Burn’s effectiveness.
• Insufficient Water Intake: Proper hydration is essential for metabolic processes. Dehydration can significantly reduce effectiveness.

Frequently Asked Questions

How quickly can I expect to see results with Java Burn?

Most users report noticing initial changes within the first 2-3 weeks of consistent use, with more significant results becoming apparent after 4-6 weeks. Individual results vary based on factors like metabolism, diet, activity level, and consistency of use.

Is Java Burn safe for people with caffeine sensitivity?

Java Burn is designed to be mixed with coffee, so it does contain additional caffeine. If you’re sensitive to caffeine, consider using it with half-caff or decaffeinated coffee, or consult with your healthcare provider before use.

Can I use Java Burn if I don’t drink coffee?

While specifically formulated for coffee, some users have reported success mixing it with tea or other warm beverages. However, optimal absorption and effectiveness are designed around coffee consumption.

Are there any side effects associated with Java Burn?

Java Burn is generally well-tolerated when used as directed. Some individuals might experience mild adjustment effects during the first few days as their metabolism adapts. These typically subside quickly. As with any supplement, discontinue use if you experience persistent discomfort.

How does Java Burn compare to other weight management supplements?

Unlike pills, powders, or shakes that replace meals, Java Burn enhances your existing routine without requiring significant changes. Its integration with morning coffee makes compliance easier than products with complex dosing schedules.

Can I take Java Burn while on medication or with existing health conditions?

If you have pre-existing health conditions or are taking medication, particularly for metabolic disorders like diabetes or thyroid issues, consult with your healthcare provider before introducing any new supplement, including Java Burn.

Conclusion

After conducting an exhaustive java burn review analysis for 2025, it’s clear that this innovative metabolic enhancer offers a unique approach to weight management that aligns with modern lifestyles. The convenience of integrating it into an existing coffee ritual, combined with its scientifically-formulated ingredient profile, makes Java Burn stand out in the crowded supplement market. While individual results naturally vary, the consistency of positive feedback across multiple java burn reviews consumer reports suggests genuine effectiveness for many users.

Java Burn represents the evolution of metabolic supplementation—moving away from complicated regimens toward simple, sustainable integration into daily life. As with any wellness product, realistic expectations and consistency are key to achieving optimal results. When combined with sensible nutrition and regular activity, Java Burn appears to be a valuable tool for those seeking to enhance their metabolic efficiency and support their weight management goals.

FDA reportedly inspected the warehouse in Leetsdale, a suburb of Pittsburgh, on June 4 and June 10.  The agency subsequently informed the company that the 1,542 cases of Jack3d and Oxylite Pro it found there that contain DMAA were considered adulterated under the law.

On April 11, FDA had issued a statement saying it “is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.”

The statement went on to say, “FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.”

GNC: Ingredient is safe

In April, in an earnings conference all with stock analysts, GNC CEO Joe Fortunato said the company was selling through its remaining stock of DMAA-containing products.

“Reality is, it’s been 15 months the military has been investigating DMAA. They found nothing that came back. We went to them three times, obviously concerned that if there was any safety issue, we wanted the product off the table. They have nothing,” Fortunato said during the call.

 “I think they issued a quick warning on those products the night before the story (on NBC). And I’m sure they did that so that they would not be pegged as saying the FDA didn’t do anything about this,” he said. “But this product is safe and I think the FDA has pretty much said that just from the fact that they haven’t pulled (DMAA-containing products) from the shelves.”

Game of chicken?

Observers of the situation said it seemed as if GNC had drawn a line in the sand as to how far it was willing to go to accommodate FDA on the DMAA affair.

“That’s a silly statement to make.  FDA has come out a number of times that they think it is unsafe.  Whether they were going to do anything about it was the question,” said Justin Prochnow, an attorney with Greenberg Traurig.

 “I’m not surprised that FDA did this at all. I think GNC was daring the agency to take a more serious enforcement action,” said Marc Ullman, an attorney with Ullman, Shapiro & Ullman.

In a statement released to the media, GNC said, “The two detained products, Jack3d and OxyELIiTE Pro, are third party products distributed by USPlabs. They represent a very small fraction of products at the Leetsdale facility.”

GNC will sell out inventory

In a statement reiterated Fortunato’s statements in the earnings call that GNC believes DMAA is safe and that the company had received no information from FDA backing the assertion that the ingredient is unsafe.  The company said it intends to continue to sell out its remaining DMAA inventory in its stores.

“(The) current inventory of products in stores will be exhausted within weeks. It is unclear then to GNC why the FDA has initiated this action at this point given DMAA-containing products are no longer being made,” the company said.

“DMAA-containing products are widely sold across the country. Yet, to the best of GNC’s knowledge, the FDA has not taken any action against the same products residing in other distributors’ warehouses or in any stores throughout the country. DMAA-containing products may continue to be sold and/or distributed everywhere in the US except this one GNC distribution facility. Given this situation, it is hard to view this action as anything other than a biased agency action against GNC in retaliation for GNC’s stance on DMAA,” the statement concluded.