No, pure phosphatidylserine is not approved by FDA. The question of whether phosphatidylserine is "FDA approved" is deceptively simple. The answer is not a straightforward yes or no, but rather a nuanced exploration of the complex regulatory landscape governing dietary supplements, drugs, and food ingredients in the United States. To state it clearly: Phosphatidylserine (PS) is not "FDA approved" as a drug for the treatment or prevention of any specific disease. However, it is a legal dietary supplement ingredient that has achieved regulatory statuses-namely Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) notifications-that allow pure phosphatidylserine to be marketed and sold to consumers. Why Phosphatidylserine Lacks FDA Approval?
What Qualifications Are Required For FDA Approval?
The U.S. Food and Drug Administration (FDA) approves new drugs and biologics after a rigorous, multi-stage process. This requires sponsors to provide "substantial evidence" from adequate and well-controlled clinical investigations that the product is both safe and effective for its intended use.
This evidence is primarily gathered through three phases of human clinical trials, which progress from initial safety and dosage studies in small groups to large-scale studies confirming efficacy and monitoring side effects. Furthermore, the manufacturer must prove it can reliably produce the drug to high quality standards, with controls to ensure its identity, strength, and purity. The FDA also requires that the proposed labeling be appropriate, providing accurate information for safe use. Ultimately, approval is only granted when the agency determines the drug's benefits outweigh its known risks for the target population.
Why Phosphatidylserine Lacks FDA Approval?
Pure phosphatidylserine is not an FDA-approved drug because it is not marketed as one; instead, it is legally sold as a dietary supplement, a category that operates under an entirely different set of rules that do not require pre-market approval for safety or efficacy. To understand this fully, one must explore the critical legal distinction between a "drug" and a "dietary supplement," the historical context of PS's sources, and the specific health claims the FDA allows it to make.
Drug Approval vs. Supplement Regulation
The most significant factor is the stark regulatory difference between a drug and a supplement, as defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994.
• The Drug Pathway:
For a substance to become an FDA-approved drug, its sponsor (typically a pharmaceutical company) must undertake a monumental, multi-phase process. This involves submitting an Investigational New Drug (IND) application, conducting extensive preclinical (lab and animal) studies, and then proceeding through three phases of human clinical trials to demonstrate conclusive evidence that the drug is both safe and effective for treating, preventing, or curing a specific disease. This process is meticulously reviewed by the FDA, often takes over a decade, and costs billions of dollars. Only after successfully proving both safety and efficacy does the agency grant approval.
• The Supplement Pathway:
DSHEA classifies dietary supplements as a subcategory of food, not drugs. Consequently, they are not subject to the same pre-market approval process. It is the sole responsibility of the manufacturer to ensure its product is safe and that any label claims are truthful and not misleading. The FDA's role is primarily reactive. Pure phosphatidylserine can take action against a supplement after it is on the market if it is found to be adulterated, misbranded, or unsafe. There is no requirement for supplement companies to prove their products are effective for any purpose. Therefore, a lack of FDA "approval" is the default status for all dietary supplements, including popular ones like vitamin D, fish oil, and probiotics.
Pure bulk Phosphatidylserine manufacturers have chosen the supplement pathway. There is no financial incentive for any company to invest the vast resources needed to run gold-standard clinical trials to get PS approved as a prescription drug for a condition like Alzheimer's disease when it can be sold profitably as a supplement for general cognitive support.
The Critical Issue of Source and Safety
The history of pure phosphatidylserine's sourcing is crucial to this discussion. Initially, in the 1980s and early 1990s, PS was derived primarily from bovine (cow) brain cortex. Early European clinical studies showing cognitive benefits used this bovine-sourced PS.
However, in the late 1990s, the emergence of Bovine Spongiform Encephalopathy (BSE, or "mad cow disease") created a significant public health crisis. The FDA took swift action to protect the food and supplement supply from potential contamination, which can cause the fatal Creutzfeldt-Jakob disease in humans. The agency effectively banned the use of bovine brain-derived ingredients in dietary supplements.
This forced the industry to adapt. Today, virtually all pure phosphatidylserine on the market is derived from plant-based sources, primarily soy and, to a lesser extent, sunflower lecithin. These sources are considered safe from the risk of prion diseases like BSE. This shift was essential for pure phosphatidylserine to remain on the market as a legal dietary supplement.
The Nuanced World of Health Claims
While supplement makers cannot claim to diagnose, treat, cure, or prevent diseases (which are "drug claims"), they can make what are known as structure/function claims. These are claims about the pure phosphatidylserine product's effect on the body's structure or function.
• An Illegal Drug Claim (for a supplement): "Treats Alzheimer's disease."
• A Legal Structure/Function Claim: "Supports memory function" or "Helps maintain cognitive health."
Pure phosphatidylserine products universally use these legal structure/function claims. Furthermore, the FDA has even granted PS a specific "qualified health claim." This is a rare category for claims that are supported by scientific evidence but do not meet the more rigorous "significant scientific agreement" standard required for an unqualified health claim.
In 2003, the FDA authorized the following qualified claim for pure phosphatidylserine: "Consumption of phosphatidylserine may reduce the risk of dementia in the elderly." However, this claim must be accompanied by a very specific disclaimer: "Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim."
This qualified claim perfectly encapsulates the situation: there is some promising but inconclusive scientific evidence for natural phosphatidylserine's benefits, which is enough for it to be sold as a supplement with specific caveats, but far from enough evidence to warrant the immense investment and scrutiny required for full FDA drug approval.
Is phosphatidylserine expected to receive FDA approval?
It is highly unlikely that pure phosphatidylserine (PS) will seek or receive FDA approval as a prescription drug in the foreseeable future. This expectation is rooted in the fundamental differences between the regulatory pathways for dietary supplements and pharmaceuticals, the economic incentives for manufacturers, and the current state of scientific evidence. Here's a detailed analysis of why FDA approval for PS is not anticipated.
Regulatory Pathway and Economic Disincentives
The most significant barrier to FDA approval is the financial and logistical burden of the drug approval process. To gain approval, a sponsor (typically a pharmaceutical company) must conduct extensive preclinical studies and large-scale, randomized, double-blind, placebo-controlled human trials to prove the substance is both safe and effective for treating a specific disease. This process can take over a decade and cost billions of dollars.
Natural phosphatidylserine is already widely available as a dietary supplement, generating revenue for manufacturers without the need for this massive investment. There is no economic incentive for any company to pursue FDA approval, as it would not only be extraordinarily expensive but also counterproductive. If PS were approved as a prescription drug for a specific condition (e.g., mild cognitive impairment), it would likely be removed from the supplement market due to regulatory conflicts. The FDA prohibits substances approved as drugs from being sold as dietary supplements. Thus, bulk phosphatidylserine manufacturers would risk losing their existing consumer market by pursuing drug status.
The Nature of Scientific Evidence
While some clinical studies suggest pure phosphatidylserine may support cognitive function, especially in aging populations, the evidence is not robust enough to meet the FDA's high bar for drug approval. Existing research often involves:
• Small sample sizes that limit statistical power.
• Short study durations are insufficient to demonstrate long-term efficacy or safety for disease treatment.
• Use of structure/function endpoints (e.g., improved memory recall) rather than endpoints the • FDA accepts for drug approval (e.g., halting progression of Alzheimer's disease).
The FDA has already acknowledged the preliminary nature of this evidence through its authorization of a qualified health claim for pure phosphatidylserine in 2003, which must include the disclaimer: "Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim." This statement highlights the gap between current research and the conclusive data required for drug approval.
Absence of a Patent Incentive
Pharmaceutical companies pursue FDA approval primarily when they can secure patent protection, guaranteeing exclusive rights to market the drug for a period and recoup their investment. Phosphatidylserine is a naturally occurring compound that cannot be patented in its natural form. While synthetic derivatives or specific formulations could potentially be patented, no company has shown interest in developing a novel, patentable version of pure phosphatidylserine for the drug approval pathway. Without the prospect of patent exclusivity, the business case for funding expensive clinical trials vanishes.
Regulatory Precedent
The regulatory history of pure phosphatidylserine further diminishes the likelihood of approval. Its initial source-bovine brain-was effectively banned due to mad cow disease concerns, leading to the shift to plant-based sources (soy, sunflower). This history complicates the regulatory picture and would require any drug application to thoroughly address safety concerns about sourcing and long-term use, adding another layer of complexity and cost.
Therefore, while not "approved," modern plant-sourced pure phosphatidylserine is a legally marketed dietary ingredient that has successfully navigated the FDA's regulatory pathways for new supplement ingredients. Guanjie Biotech is a raw material phosphatidylserine supplier. We supply bulk soy phosphatidylserine and sunflower phosphatidylserine with different specifications. Welcome to enquire with us at info@gybiotech.com.
References
U.S. Food and Drug Administration (FDA). (2003). *FDA Announces Qualified Health Claims for Omega-3 Fatty Acids* [Press Release].
[2]U.S. Food and Drug Administration (FDA). (2022). What is a Dietary Supplement? https://www.fda.gov/food/dietary-supplements/what-dietary-supplement
[3]U.S. Food and Drug Administration (FDA). (2018). Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-dietary-supplement-new-dietary-ingredient-notifications-and-related-issues
[4]Glade, M. J., & Smith, K. (2015). Phosphatidylserine and the human brain. Nutrition, 31(6), 781–786.
[5]Hellhammer, J., Fries, E., Buss, C., et al. (2004). Effects of soy lecithin phosphatidic acid and phosphatidylserine complex (PAS) on the endocrine and psychological responses to mental stress. Stress, 7(2), 119–126.
[6] U.S. Food and Drug Administration (FDA). (2021). Frequently Asked Questions on the Patentability of Inventions Devised Using Artificial Intelligence.
