Sexual wellness is no longer a peripheral category in the nutraceutical industry. The global sexual health supplements market was valued at approximately USD 3.5 billion in 2023 and is projected to reach around USD 7 billion by 2030, growing at a compound annual growth rate of 10.4% (2024–2030) according to Grand View Research. That growth reflects a fundamental shift: consumers now view sexual health as integral to overall wellness rather than an isolated concern.
For nutraceutical brands and product development teams evaluating sexual wellness ingredients, this shift creates both opportunity and risk. The opportunity is clear. The risk lies in a category that continues to attract significant regulatory scrutiny. The FDA1 regularly identifies products marketed for sexual enhancement that contain undeclared pharmaceutical ingredients, including sildenafil and tadalafil. Recent FDA notifications in 2025 and 2026 show that adulteration remains an active concern in the category, reinforcing the importance of ingredient traceability, quality control and scientifically substantiated claims. Selecting the right ingredient therefore requires a particularly rigorous evaluation framework.
Key takeaways
- Scientific evidence should be evaluated according to its design and relevance, rather than treated as interchangeable.
- Standardization helps ensure a consistent phytochemical profile across production batches.
- Traceability and analytical controls are particularly important in a category affected by adulteration concerns.
- Formulation factors such as dosage, stability and sensory characteristics should be considered during product development.
- Multi-target botanical ingredients can be investigated across complementary biological pathways relevant to sexual function.
What biological mechanisms matter most in sexual wellness ingredients?
Sexual function involves coordinated activity across vascular, endocrine and neurological systems. Natural ingredients developed for this category may act through multiple biological pathways, including vascular and endocrine mechanisms.
One key pathway is the nitric oxide-cGMP signaling axis, which plays an important role in vascular relaxation in genital tissue in both men and women. Nitric oxide activates guanylate cyclase, increases cyclic GMP and promotes smooth muscle relaxation. Phosphodiesterase type 5 (PDE5) degrades cGMP, so ingredients that promote nitric oxide production or influence PDE5 expression may interact with this pathway.
Another relevant pathway involves androgen-estrogen balance regulated by aromatase. Aromatase converts androgens to estrogens, and modulation of aromatase activity may influence androgen-estrogen balance, a pathway relevant to sexual function.
A multi-target ingredient that influences more than one relevant biological pathway may offer a broader mechanistic profile than a single-target compound. Recent in vitro research published in Pharmaceuticals² in April 2026 investigated this multi-target activity in a standardized Turnera diffusa extract (Liboost®), reporting reduced PDE5 expression, inhibition of aromatase activity and a moderate increase in nitric oxide production. Together, these findings suggest potential modulation of vascular, endocrine and nitrergic pathways relevant to sexual function.
How should R&D teams evaluate the evidence behind sexual wellness botanicals?
R&D teams should evaluate sexual wellness botanicals according to the type, quality and relevance of the available evidence. Not all evidence carries the same weight, and understanding what conclusions can reasonably be drawn from each type of research is just as important as the results themselves.
Randomized, double-blind, placebo-controlled clinical trials provide the strongest level of evidence for evaluating efficacy. Study population, duration, dosage and the use of validated outcome measures are all essential when assessing how relevant the findings may be to a finished product.
Real-life and consumer studies can provide a different type of insight. While they should not be interpreted as equivalent to controlled clinical trials, they can help evaluate consumer experience, perceived benefits and the relevance of an ingredient under everyday conditions.
Liboost®, for example, has been evaluated in a consumer study3 involving both men and women, exploring areas such as sexual desire, arousal, satisfaction and overall sexual wellbeing. These human observations are complemented by mechanistic research investigating biological pathways related to nitric oxide, PDE5 and aromatase.
Mechanistic in vitro research provides another layer of evidence by helping establish biological plausibility and identify the compounds and pathways potentially responsible for an ingredient’s activity. Phytochemical characterization can further connect these biological effects with defined constituents of a standardized botanical extract.
Taken together, these different levels of evidence help R&D teams understand not only whether an ingredient shows potential, but also how robustly that potential has been characterized and where further research may still be needed.
Why does phytochemical standardization determine formulation success?
Phytochemical standardization helps ensure that a botanical ingredient maintains a consistent and reproducible composition across production batches. This is particularly important because extracts from the same plant species can differ substantially depending on factors such as extraction conditions and raw material quality.
Standardization to identified bioactive markers is what makes an ingredient reproducible. When an extract is characterized by HPLC and standardized to contain a defined concentration of selected constituents, manufacturers can maintain a more consistent phytochemical profile across production batches. Without this standardization, formulators cannot reliably ensure that the composition evaluated in research is reproduced in the finished product.
Consider Turnera diffusa as an illustration. An HPLC-DAD-HRMS analysis of the Liboost® extract identified 49 compounds, predominantly flavonoids including luteolin and apigenin derivatives, methoxyflavones, and flavanones, with a total quantified flavonoid content of 15.9 mg per gram. The extract is standardized to contain more than 1.5% total flavonoids (commercially designated Liboonoides®). This level of characterization enables quality control at every stage from raw material to finished dose form.
Contrast this with unstandardized botanicals where relevant compounds are not identified, quantified, or controlled across batches. Formulators working with such materials face an inherent reproducibility challenge that cannot be addressed solely through good manufacturing practices at the finished-product stage.
Why does substantiation matter in sexual wellness?
Sexual wellness is a category where scientific evidence and regulatory positioning need to be considered together. In the United States4, dietary supplement structure/function claims must be truthful, not misleading and supported by appropriate substantiation, while claims that explicitly or implicitly refer to the diagnosis, treatment, mitigation, cure or prevention of disease fall outside this framework.
For product development teams, this makes the quality and relevance of the supporting evidence particularly important. The strength of substantiation should be considered in relation to the specific message being communicated, taking into account factors such as the type of evidence available, the population studied, the endpoints evaluated and how directly the research supports the intended positioning.
Mechanistic, phytochemical, consumer and clinical research can each contribute different information to an ingredient’s scientific dossier, but they should not be treated as interchangeable levels of evidence. Understanding these distinctions helps brands develop communication that accurately reflects what has been studied while identifying where additional research may be needed.
For ingredient selection, regulatory readiness therefore goes beyond identifying an appealing benefit. It means evaluating whether the scientific documentation, quality controls and available evidence provide a sufficiently robust foundation for the intended product positioning in the target market.
How does adulteration risk affect ingredient selection decisions?
Adulteration risk makes traceability, identity testing and robust quality controls particularly important when selecting sexual wellness ingredients. Sexual enhancement supplements have historically represented a significant share of adulterated dietary supplements identified by the FDA, and recent notifications show that the issue remains relevant today.
For formulators, this reinforces the importance of ingredient traceability, identity testing and robust quality controls throughout the supply chain.
When evaluating a sexual wellness ingredient supplier, product development teams should consider several quality markers. Traceability from raw material through extraction to finished ingredient provides visibility across the supply chain. Validated identity testing helps confirm ingredient authenticity, while batch-specific certificates of analysis provide documentation that defined specifications have been met. Appropriate screening for potential adulterants can provide an additional layer of quality assurance in a category subject to continued regulatory scrutiny.
In this context, Pharmactive researchers, in collaboration with the Instituto de Química Orgánica General (IQOG-CSIC), have developed and validated analytical strategies specifically for the detection of PDE5 inhibitors in Turnera diffusa (damiana) products. The study2 evaluated three analytical methods — LC-DAD, LC-Q MS and FIA-ToF MS — for the detection and quantification of avanafil, vardenafil, sildenafil and tadalafil. The FIA-ToF MS approach provided a rapid screening workflow, reducing analysis time to approximately one minute per sample while maintaining satisfactory sensitivity, precision and accuracy. This type of targeted analytical research can strengthen quality control strategies for damiana-based ingredients and products.
Suppliers that maintain control and oversight across sourcing, extraction, standardization and quality testing can provide greater transparency and consistency. Manufacturing under recognized quality systems such as GMP, together with robust analytical controls, further strengthens confidence in ingredient quality and traceability.
What formulation factors should be considered when selecting a sexual wellness ingredient?
Formulators should consider the studied dose, stability, physicochemical characteristics and sensory profile of an ingredient alongside its scientific evidence. These factors determine how easily a botanical extract can be incorporated into a practical, stable and consumer-appropriate finished product.
Dosage is an important consideration. The amount evaluated in available research should be compatible with the intended serving size and dosage form. Ingredients used at relatively low amounts can offer greater formulation flexibility, particularly in multi-ingredient products where capsule space or serving size may be limited.
Stability is another important factor. Botanical constituents can be affected by manufacturing and storage conditions, including heat, oxidation, moisture and interactions with other formulation components. Appropriate stability data and handling guidance can therefore help maintain ingredient specifications throughout the product’s shelf life.
The physicochemical characteristics of botanical compounds may also influence formulation decisions. Solubility, processing conditions and interactions with other ingredients can affect how an extract behaves within different delivery formats and should be considered during product development.
Finally, sensory characteristics matter, particularly in consumer-facing formats. Botanical extracts with pronounced taste, aroma or color may require additional formulation strategies when used in chewables, powders, gummies or beverages.
Together, these considerations help formulators select ingredients that are not only scientifically characterized, but also practical to incorporate into a stable and consumer-appropriate finished product.
How is the sexual wellness ingredient category evolving for brands?
Sexual wellness is increasingly moving beyond the traditional focus on male performance toward a broader view of wellbeing that includes desire, arousal, satisfaction, hormonal health and different life stages in both sexes. This evolution is creating opportunities for brands to develop more inclusive formulations that address sexual wellbeing as part of a wider health and wellness context.
For ingredient selection, this broader perspective favors ingredients that can be relevant across different consumer groups and that are supported by clearly characterized mechanisms and appropriate scientific evidence. Rather than focusing exclusively on a single aspect of sexual performance, product developers are increasingly considering multiple dimensions of sexual wellbeing and how they intersect with areas such as stress, hormonal changes, circulation and healthy aging.
For brands entering or expanding in this category, differentiation increasingly depends on the quality of the ingredient itself: reproducible standardization, transparent sourcing, robust analytical characterization and a scientific dossier that accurately reflects the level of evidence available. Broad traditional positioning alone may be less compelling in a category where both consumers and industry stakeholders are placing greater emphasis on transparency and substantiation.
Liboost® reflects this evidence-led approach. The standardized Turnera diffusa extract combines detailed phytochemical characterization with consumer research and published mechanistic studies exploring multiple biological pathways relevant to sexual function. For formulators and brand owners, this combination of standardization, scientific characterization and technical documentation can provide a stronger foundation for developing differentiated sexual wellness products.
REFERENCES:
(1). U.S. Food and Drug Administration (FDA). Sexual Enhancement and Energy Product Notifications. 2026.
(2) Benito-Vázquez I, et al. Pharmaceuticals. 2026;19(4):597.
(3) Pharmactive Biotech Products. Liboost® Real-Life Consumer Study. 2019.
(4) U.S. Food and Drug Administration (FDA). Structure/Function Claims.
(5) Jiménez-Amezcua I, et al. Journal of Chromatography A. 2026;1784:467204.
