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How to Formulate a Functional Beverage: From Target Profile to Shelf-Stable Batch (2026)

How to formulate a functional beverage: write a target profile for taste, function, dose, cost and claim route; dose the actives with an overage set from stability data; balance pH and stabilisers; choose a process that meets the US rule for your product type and still protects the active; then prove the dose and safety at the end of shelf life before you scale up.[1][2]
SIDr Shreya Iyer
PhD (Food Science) · Director of New Product Development, Food Research Lab
✓ Technically reviewed by FRL Editorial · Last reviewed: 5 November 2026 · Next review: May 2027
Posted
5 November 2026

Last checked
5 November 2026

Reading time
9 min

Sources
15
At a glance
  • A functional beverage is formulated in five steps: target profile, actives and base, process, stability and scale-up.
  • Decide early whether the drink is a beverage or a dietary supplement; FDA looks at name, packaging, serving size, labelling and marketing.
  • Set overage from stability data: vitamin C in apple juice stayed above 85% at 4 °C but fell below 40% at 35 °C over 60 days.
  • pH 4.6 and water activity 0.85 decide whether 21 CFR Part 113 (low-acid) or Part 114 (acidified) applies; juice drinks also need Part 120 HACCP.
  • Hurdle technology can protect actives, but it works inside the applicable rule, not instead of a scheduled process.
Key numbers
pH 4.6
Finished equilibrium pH that separates low-acid from acid and acidified foods [2]
aw 0.85
Water activity above which a low-acid food falls under Part 113 [7]
Above 85%
Vitamin C kept in apple juice after 60 days at 4 °C [1]
Below 40%
Vitamin C kept after 60 days at 35 °C [1]
5-log
Minimum pathogen reduction for juice under HACCP [9]
3 years
Record retention for acidified-food processing and pH records [2]

How to formulate a functional beverage: what the process involves

A functional drink has to taste good, deliver its dose and stay safe and stable on a US shelf, and those goals pull against each other. This guide sets out how to formulate a functional beverage in five steps, from target profile to a shelf-stable batch, so you can brief a lab with the right questions. It is the hub of our functional beverage series: if you are still budgeting, start with the functional beverage development cost guide.

Formulation vs a kitchen recipe

A recipe lists ingredients and steps. A functional beverage formulation adds specifications, a dose target per serving with its overage, pH and processing limits, and the tests that prove each batch. That documentation is what lets the drink be repeated at scale and defended on the label (Figure 1).

Five-step functional beverage formulation workflow: 1 target (taste, function, dose and claims), 2 actives (select, dose and balance base), 3 process (heat and preservation), 4 stability (shelf life and dose retention), 5 scale-up (pilot and commercial run)
Figure 1. Five-step workflow for formulating a functional beverage, from target profile to scale-up.

Step 1: Define the target profile and the claim route

Taste, function, dose, cost and claims

Write down five things before the first bench trial: the target sensory profile, the function, the dose per serving, the cost ceiling and the claim route. Each one becomes a number with a tolerance and a test.

Beverage or dietary supplement?

The claim route matters in the US because a liquid can be sold as a conventional food (a beverage) or as a dietary supplement, and the rules differ. FDA’s 2014 guidance says it looks at how the product is represented, including its name, packaging, serving size and recommended intake, its labelling and advertising, and its composition.[3] Structure/function claims are allowed on both. A dietary supplement that carries one must be notified to FDA no later than 30 days after first marketing; a conventional food has no such notification step.[4][5]

Settle this first, because it shapes the ingredients, the label and the cost. For the classification rules, see functional beverages vs functional foods; for the US regulatory questions brands ask most, see our functional beverage FDA regulations Q&A.

Step 2: Select actives and balance the base

Active dosing, overage and bioaccessibility

Set the dose and overage from stability data, not from the label figure alone. In pasteurised apple juice, vitamin C stayed above 85% of its starting level after 60 days at 4 °C but fell below 40% at 35 °C, so the same label claim needs a very different overage depending on how the drink is stored.[1] The process also changes how much of an active the body can access: in one study of high-pressure-processed tomato juice, all-trans lycopene bioaccessibility peaked at 6.86% at 500 MPa.[6] Our guide to bioactives in functional beverages covers ingredient choice in more depth.

Acidulants, sweeteners and stabilisers

Choose pH, acidulants and buffering early, because acidity is both a taste lever and a safety control. In the US, a finished equilibrium pH of 4.6 is the line between low-acid and acid or acidified foods (Step 3).[2][7] Where protein or oil is present, the base also needs a stabiliser or hydrocolloid system, and minerals can undo it. In an acidic (pH 2.0) pea-protein emulsion, adding 0.5 M salt raised mean droplet size from 0.55 µm to 0.95 µm, and heating at 90 °C for 30 minutes with the salt raised it to 3.00 µm, a sign of extensive aggregation.[8] Sweeteners are chosen against the target profile and the cost ceiling.

Table 1. Choices in the drink base

Choice What it controls Evidence or rule
Active and dose Function and label claim Dose loss depends on storage temperature[1]
pH and acidulant Taste and microbial safety pH 4.6 sets which US process rule applies[2][7]
Stabiliser system Suspension and emulsion stability Salt and heat can aggregate protein-stabilised droplets[8]
Sweetener Taste and cost Set by the target profile

Step 3: Choose the process and the US rule it falls under

Which US rule applies to your drink

Before choosing equipment, work out which set of FDA rules your drink falls under. The finished equilibrium pH, the water activity (aw), whether it contains juice, and whether it is sold chilled or at ambient temperature decide it.

Table 2. US process rules by beverage type

Drink type Rule What it means for formulation
Low-acid (pH above 4.6, aw above 0.85), shelf-stable in a sealed container, e.g. many plant-protein drinks 21 CFR Part 113 Commercial sterility by retort or aseptic processing; scheduled process set by a qualified person[7]
Acidified (acid added to a low-acid base to reach pH 4.6 or below) 21 CFR Part 114 pH controlled, tested often and recorded; scheduled process set by a qualified person[2]
Contains juice 21 CFR Part 120 (juice HACCP) A HACCP plan with at least a 5-log reduction of the pertinent pathogen, unless the processor is under Part 113 or 114[9]
Carbonated, or kept refrigerated Excluded from Part 114 Other rules, such as FSMA preventive controls, still apply[2][10]

Acidified and low-acid processors must also register the establishment with FDA and file each scheduled process no later than 60 days after registration and before packing a new product.[11] Facilities covered by Part 113 or Part 120 are exempt from the FSMA hazard analysis and preventive controls subparts only for the hazards those parts control.[10] Our guide to FDA food facility registration covers the general registration step.

Pasteurisation, aseptic and hurdle approaches

Processing is a trade-off between safety and active protection. Heat is the usual route to safety and shelf life, but it has costs. UHT processing can change how plant proteins behave in plant-based beverages.[12] In a tropical fruit juice blend, pasteurisation at 85 °C for 30 seconds cut ascorbic acid by about 7%.[6] Heat also reduces some bioactive compounds, which is why non-thermal options are being studied.[13]

Hurdle technology combines several mild controls, such as pH, water activity, preservatives and a gentler heat step, so that no single control has to be severe.[14][15] It can protect sensitive actives, but only within the US rule your drink falls under; it does not replace a scheduled process. Our hurdle technology guide for functional drinks explains how to combine them. For retorted products, pilot retort trials let you test a heat process before committing to a line, and our review of plant-based beverage stability after heat treatment covers what UHT can do to texture and sedimentation.

Step 4: Prove stability to the end of shelf life

Run shelf-life and stability testing against three things: the active, the sensory profile and the microbiology. The apple juice study held samples at 4, 25 and 35 °C for 60 days, found that losses followed first-order kinetics, and used Arrhenius and Q10 analysis so the results could support accelerated shelf-life testing.[1] Accelerated data are a prediction, so confirm them with real-time samples; our comparison of real-time vs accelerated shelf-life testing explains the limits.

Choose storage conditions that match the US supply chain you expect, including warm warehouses and trucks, then test the dose at the end of shelf life, not only at day zero. Physical checks such as sedimentation and phase separation belong in the same study; see beverage stability testing for the test set.

Step 5: Get ready for scale-up

Before scale-up, lock the formula, the process limits and the test methods. For an acidified or low-acid drink, a qualified person with expert knowledge of the process must establish the scheduled process, and acidified-food processors must keep processing and pH records for 3 years from the date of manufacture.[2][7]

Recheck the dose, pH and stability on the first pilot run, because larger batches, longer hold times and different heat exchangers expose problems the bench hides. Newer non-thermal methods carry extra risk here: the ultrasound and thermosonication beverage studies reviewed in 2024 were all at laboratory scale.[13] Our heat-stable plant beverage development worked example follows one drink through these steps.

A functional beverage formulation checklist

Table 3. Checklist from target profile to scale-up

Step Check
1. Target Taste, function, dose, cost ceiling and claim route (beverage or supplement) written down[3][4]
2. Actives Dose and overage set from stability data[1]
3. Base pH, acidulant and stabilisers chosen; finished equilibrium pH and aw measured[2][7]
4. Process US rule identified (Part 113, 114 or 120, or none); heat or hurdle approach chosen for safety and active protection[7][2][9][14]
5. Stability Dose, sensory and microbiology tested to the end of shelf life[1]
6. Scale-up Scheduled process by a qualified person, FDA registration and process filing, records in place[11][2]

Formulator’s note: formulate for the end of shelf life. The label claim must be true on the last day, not the first. Set the dose and overage for the warmest storage condition you expect.

Conclusion

Functional beverage development follows an order: a written target profile, actives dosed from stability data, a balanced base, a process that meets the right US rule and protects the active, and a stability study that supports the label. Decide the product category and the claim early, because they shape everything after. Next in the series, read our hurdle technology guide.

For brands & formulators

Food Research Lab’s beverage formulation team can turn your brief into a target profile, select and dose the actives, build the base and plan the process and stability study around the US rule your drink falls under. We run stability and microbiological testing, or arrange it through accredited partner laboratories, as part of a shelf-life study.

For heat-processed drinks, you can book pilot retort trials before scale-up. Or contact us with your brief.

In this series

What to do now
  • ✓Write the target profile: taste, function, dose per serving, cost ceiling and claim route.
  • ✓Decide beverage or dietary supplement before artwork, using FDA’s 2014 guidance factors.
  • ✓Measure finished pH and water activity on the bench prototype to see whether Part 113, 114 or 120 applies.
  • ✓Plan the stability study at your warmest expected storage temperature and set the overage from it.
  • ✓Line up a qualified process authority and FDA process filing before the first commercial run.
Your next step
Turn your functional drink brief into a stable batch
1Share the concept, target actives and dose, format and intended US claim route.
2FRL builds the target profile and base, and maps the drink to the applicable US process rule.
3Get a formulation and stability plan, with pilot trials before scale-up.
Questions brands ask
How do you formulate a functional beverage?

Start with a written target profile for taste, function, dose, cost and claim route. Then select and dose the actives with an overage based on stability data, balance pH and stabilisers, and choose a process that meets the applicable US rule. Finally, test the dose, sensory quality and microbiology to the end of shelf life before scale-up.[1][2]

What is the difference between a recipe and a functional beverage formulation?

A recipe lists ingredients and method. A functional beverage formulation is a documented specification: exact ingredient levels, a dose target per serving with overage, pH and processing limits, and the tests that prove every batch. That documentation lets the drink be reproduced at scale and supports what the label says.

How do you keep actives stable in a functional drink?

Control pH, limit heat and oxygen exposure, choose packaging that protects the active, and add an overage that covers the expected loss. Storage temperature matters: in one apple juice study, vitamin C stayed above 85% at 4 °C but fell below 40% at 35 °C over 60 days.[1]

What pH does a shelf-stable functional beverage need in the US?

There is no single required pH. A drink with a finished equilibrium pH of 4.6 or below can be an acid or acidified food, while a drink above pH 4.6 with water activity above 0.85 is a low-acid food that needs a commercially sterile process, such as retort or aseptic processing.[2][7]

Is a functional drink a beverage or a dietary supplement in the US?

It depends on how it is represented. FDA’s 2014 guidance looks at factors such as the product name, packaging, serving size, recommended intake, labelling, advertising and composition. Drinks sold in soda-, juice- or water-style containers and consumed like beverages are usually treated as conventional foods, not supplements.[3]

What makes functional beverage formulation difficult?

Taste, dose, stability, safety and cost all interact. Raising a dose can spoil flavour, lowering pH can change protein stability, and a stronger heat process can destroy the active. The drink must also fit the right US process rule. Getting all of these right usually takes several rounds of bench trials and stability testing.[8][6]

References
  1. Stan, G. E., Tudorache, M., Alexe, A. I., Adriani, L., & Moise, A. E. (2025). Kinetics of nutritional degradation of apple juice influenced by storage conditions. Scientific Papers. Series D. Animal Science, 68(1), 489–498. https://animalsciencejournal.usamv.ro/pdf/2025/issue_1/Art58.pdf (cited for vitamin C retention above 85% at 4 °C and below 40% at 35 °C after 60 days in pasteurised apple juice, first-order kinetics, and Arrhenius and Q10 analysis for accelerated shelf-life testing).
  2. U.S. Food and Drug Administration. (2026). 21 CFR Part 114: Acidified foods. Electronic Code of Federal Regulations (current as of 3 November 2026). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114 (cited for the definitions of acid and acidified foods, the aw 0.85 and pH 4.6 limits, the exclusion of carbonated beverages and refrigerated foods (§ 114.3), frequent pH testing and recording (§ 114.80), the qualified person who establishes the scheduled process (§ 114.83) and 3-year record retention (§ 114.100)).
  3. U.S. Food and Drug Administration. (2014, January). Guidance for industry: Distinguishing liquid dietary supplements from beverages. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-distinguishing-liquid-dietary-supplements-beverages (cited for the factors FDA weighs in deciding whether a liquid is represented as a beverage or a dietary supplement).
  4. U.S. Food and Drug Administration. (n.d.). Structure/function claims. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/structurefunction-claims (cited for structure/function claims on conventional foods and dietary supplements, and the dietary supplement notification requirement).
  5. U.S. Food and Drug Administration. (2026). 21 CFR 101.93: Certain types of statements for dietary supplements. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-F/section-101.93 (cited for notifying FDA no later than 30 days after first marketing a dietary supplement that bears a structure/function statement).
  6. Putnik, P., Pavlić, B., Šojić, B., Zavadlav, S., Žuntar, I., Kao, L., Kitonić, D., & Kovačević, D. B. (2020). Innovative hurdle technologies for the preservation of functional fruit juices. Foods, 9(6), 699. https://doi.org/10.3390/foods9060699 (cited for the studies it reviews: a 7% ascorbic acid loss after pasteurising a tropical fruit juice blend at 85 °C for 30 s, and the highest all-trans lycopene bioaccessibility in high-pressure-processed tomato juice (6.86%) at 500 MPa).
  7. U.S. Food and Drug Administration. (2026). 21 CFR Part 113: Thermally processed low-acid foods packaged in hermetically sealed containers. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-113 (cited for the definition of low-acid foods, commercial sterility and scheduled processes set by qualified persons (§§ 113.3, 113.83)).
  8. Nikbakht Nasrabadi, M., Eskin, M. N. A., Thiyam-Hollander, U., & Ghosh, S. (2025). On the stability of acid-soluble pea protein-stabilized beverage emulsions against salt addition and heat treatment. RSC Advances, 15(23), 18430–18443. https://doi.org/10.1039/d4ra06899h (cited for droplet size (D4,3) rising from 0.55 µm to 0.95 µm with 0.5 M NaCl and to 3.00 µm after heating at 90 °C for 30 min with salt, in a pH 2.0 emulsion).
  9. U.S. Food and Drug Administration. (2026). 21 CFR Part 120: Hazard Analysis and Critical Control Point (HACCP) systems. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120 (cited for juice used as a beverage ingredient falling under Part 120 and the 5-log pathogen reduction requirement, with exemptions for processors under Parts 113 and 114 (§§ 120.1, 120.24)).
  10. U.S. Food and Drug Administration. (2026). 21 CFR 117.5: Exemptions [FSMA preventive controls for human food]. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-A/section-117.5 (cited for the hazard analysis and preventive controls subparts not applying to activities covered by Part 120, or by Part 113 for its microbiological hazards).
  11. U.S. Food and Drug Administration. (2026). 21 CFR Part 108: Emergency permit control. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-108 (cited for establishment registration (Form FDA 2541) and scheduled-process filing no later than 60 days after registration and before packing a new product, for acidified (§ 108.25) and low-acid (§ 108.35) foods).
  12. da Silva Matos, J., Azevedo, P. Z., Costa, J. E. G., Justino, H. de F. M., Lamarão, C. V., & Sanches, E. A. (2024). UHT processing in the context of plant-based beverages: A scientific review on product characteristics and the functional role of plant proteins. Food Chemistry Advances, 5, 100848. https://doi.org/10.1016/j.focha.2024.100848 (cited for UHT processing affecting plant-protein function and product characteristics in plant-based beverages).
  13. Sotelo-Lara, D. M., Amador-Espejo, G. G., Álvarez-Araiza, D. F., Cordero-Rivera, A. K., Millán-Quintero, K. G., Campos-Vega, R., & Velázquez-Estrada, R. M. (2024). Ultrasound and thermosonication as promising technologies for processing plant-based beverages: A review. Food Technology and Biotechnology, 62(4), 538–552. https://doi.org/10.17113/ftb.62.04.24.8624 (cited for heat treatments reducing some bioactive compounds, and for ultrasound and thermosonication beverage studies being laboratory scale so far).
  14. Leistner, L. (2000). Basic aspects of food preservation by hurdle technology. International Journal of Food Microbiology, 55(1–3), 181–186. https://doi.org/10.1016/S0168-1605(00)00161-6 (cited for the hurdle concept: combining several mild preservative factors instead of one severe one).
  15. Abdullahi, N., & Dandago, M. A. (2021). Hurdle technology: Principles and recent applications in foods. Indonesian Food and Nutrition Progress, 17(1), 6–11. https://doi.org/10.22146/ifnp.52552 (cited for common hurdles such as temperature, pH, water activity and preservatives, and their use to protect product quality).