Fiber Supplements Manufacturer

The same gram target can land in different formats once density, water binding, gel strength and piece count are included. These rows are a first screen. The trial on the selected ingredient decides the format.

Commercial inulin labels in Prebiotic Fiber Gummies show how piece count carries a mid-gram soluble fiber. A gel-forming psyllium serving of the same grams is a different manufacturing job. US and EU wording for “good source,” “high,” “source of fibre” and “high fibre” is in Fiber Content Claims.

A project moves through the brief, a specification and feasibility review, a sample when the formula needs one, label review, and production.

The sweetener system and the sugar level are part of the gummy specification. Powder specifications cover dispersion and moisture protection. Sugar-free wording is reviewed with the sweetener system and the destination market. The brief names that market, and the label is reviewed against its rules.

The ranges below are KS planning figures for finished supplements and schedule a first look. The quotation sets the confirmed minimum and calendar for each SKU, and formula, fill weight, packaging, testing, a new flavor and the production schedule can change both.

The quotation then separates tubs or pouches, sticks and bulk powder, because fill weight, film and batch weight change the confirmed minimum. Where a commercial window is still open, the table says the project is quoted, and no day count is added.

A sample and a commercial batch are separate stages.

Documents for the project are the ingredient specification, the lot COA and an allergen statement for the lots used. Non-GMO documentation is included when it is available for that material. Shelf life is set from stability data on the finished format and pack.

Initial inquiries are typically answered within one business day. An NDA is available before a proprietary formula is opened.

Figures are group-wide. Capacity for a specific fiber format is confirmed by trial. Powder blending and stick-pack filling are assessed per project and are not given a daily rate in this table. Minimums and calendars for a SKU are in Planning Minimums and Timing.

Certifications include cGMP/GMP, ISO 9001, ISO 22000, HACCP, FSSC 22000, Halal and Kosher. Each applies to the legal entity, site and scope stated on its certificate. Halal and Kosher for a given fiber follow that certificate scope.

Ingredient weight, the fiber content of that ingredient, and the dietary fiber declared on the finished panel are three different numbers. The declared value follows the agreed method and records for that formula. A specification figure is not copied onto the label as a released result.

The specification defines what is purchased. The lot COA reports what that lot delivered. The release report confirms the finished SKU against its own specification. A certificate states the legal entity, site and scope it covers. Which declaration rule applies is set out under Fiber Content Claims and US Dietary Fiber Labeling.

This section covers nutrient-content claims for dietary fiber. Health-claim conditions for psyllium, oat and barley beta-glucan, native chicory inulin and glucomannan are in Market-Specific Claim Conditions. The destination market, the product category and the finished formula decide which set applies.

United States. 21 CFR 101.54 measures “good source,” “contains” and “provides” at 10 to 19 percent of the Daily Value per reference amount customarily consumed, and “high,” “rich in” and “excellent source” at 20 percent or more. The Daily Value for dietary fiber is 28 g, so those bands are about 2.8 g to 5.3 g and about 5.6 g or more on that reference amount. For a dietary supplement, 21 CFR 101.12 sets the reference amount as the maximum amount recommended on the label for consumption per eating occasion, or one unit when the label gives no recommendation. The declared grams still have to follow the dietary-fiber rules in US Dietary Fiber Labeling. If the food is not low in total fat, the label discloses total fat next to the fiber claim. The product category and the rest of 101.54 still have to fit before “high” is used.

European Union. Regulation (EC) No 1924/2006 sets “source of fibre” at 3 g of fibre per 100 g or 1.5 g per 100 kcal, and “high fibre” at 6 g per 100 g or 3 g per 100 kcal. The basis is per 100 g or per 100 kcal.

US Dietary Fiber Labeling

Isolated or synthetic non-digestible carbohydrates are assessed against the applicable FDA definition and guidance before any gram is declared. Being named below answers an identity question. The grams still come from the finished-product calculation in the specification table.

21 CFR 101.9(c)(6)(i) includes the following isolated or synthetic non-digestible carbohydrates in the dietary fiber calculation, because FDA has determined that they have physiological effects beneficial to human health: beta-glucan soluble fiber as described in 21 CFR 101.81, psyllium husk as described in that same section, cellulose, guar gum, pectin, locust bean gum, and hydroxypropyl methylcellulose.

FDA’s dietary fiber questions and answers also names carbohydrates the agency intends to propose adding to the definition. The guidance issued on June 14, 2018, The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels, is the enforcement-discretion notice for eight of them: mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high-amylose starch (resistant starch 2), galactooligosaccharides, polydextrose, and resistant maltodextrin/dextrin. Later notices added, among others, cross-linked phosphorylated RS4 in March 2019, glucomannan in January 2020 and acacia (gum arabic) in December 2021. Section 101.9(c)(6)(i) lists the seven carbohydrates named above. The additional names remain an intent to propose, with enforcement discretion while rulemaking is unfinished.

The same questions and answers describe mixed plant cell wall fibers, a broad category that includes apple fiber, as one of those intended additions. An apple-derived powder is checked against that identity. The category does not clear every apple ingredient. Green banana resistant starch is checked as green banana, rather than as high-amylose maize starch or resistant dextrin.

A wheat-derived ingredient does not, by itself, decide a gluten-free claim. Under 21 CFR 101.91, a food using the claim must meet the ingredient conditions in that section, and any unavoidable gluten must be below 20 ppm. Wheat remains a major allergen. When wheat is declared in the ingredient list or in a “Contains wheat” statement and the label also uses a gluten-free claim, 21 CFR 101.91(b)(3) requires the wheat declaration to carry the asterisk statement that the wheat has been processed to allow the food to meet FDA requirements for gluten-free foods. A food that uses both and omits that statement is misbranded. Eligibility for a given SKU still depends on processing history, cross-contact controls and the records for that finished product. FDA’s gluten-free labeling questions and answers summarize the rule.

These are health-claim conditions for the named fibers, including the required label statements. They are separate from the nutrient-content claims above.

• US soluble-fiber claim (21 CFR 101.81). For psyllium, the qualifying husk is psyllium seed husk at a purity of no less than 95 percent, with 3 percent or less protein, 4.5 percent or less light extraneous matter, and 0.5 percent or less heavy extraneous matter. Combined extraneous matter may not exceed 4.9 percent. The food contains at least 1.7 g of soluble fiber from that husk per reference amount customarily consumed. The daily level in the claim is 7 g or more of soluble fiber from psyllium seed husk. Soluble fiber for this claim is determined by the method incorporated in that section. The husk-extract specification of soluble fiber ≥ 85% does not, by itself, meet the 95 percent purity condition. The food that bears the claim, including a dietary supplement, has to meet the low-saturated-fat, low-cholesterol and low-fat conditions in that section. The low-fat condition has an exception when the fat comes from the eligible whole-oat sources. The same section sets separate conditions for beta-glucan soluble fiber from the whole-oat and barley sources named there, including 3 g or more per day. A 10:1 oat extract is not one of those sources.
• EU native chicory inulin claim (Regulation (EU) 2015/2314). The bowel-function claim may be used only for a food that provides a daily intake of at least 12 g of native chicory inulin. Native chicory inulin in that entry is a non-fractionated mixture of monosaccharides below 10 percent, disaccharides, inulin-type fructans, and inulin extracted from chicory, with a mean degree of polymerization of at least 9. The label has to tell the consumer that the effect is obtained with a daily intake of 12 g of chicory inulin. A 4 g gummy serving does not itself provide that daily intake. A high-purity grade does not establish the native-inulin definition. The claim is listed in the EU Register of nutrition and health claims.
• EU glucomannan claim (Regulation (EU) No 432/2012). The weight-loss claim may be used only for a food that contains 1 g of glucomannan per quantified portion. The consumer information states that the effect is obtained with 3 g of glucomannan a day, in three doses of 1 g, together with 1–2 glasses of water, before meals, in an energy-restricted diet. The claim also requires a choking warning for swallowing difficulty or too little fluid, and advice to take the product with water so it reaches the stomach. Those grams are glucomannan, not konjac-extract weight. The same register lists the conditions of use.

The brand owner is responsible for the final label and claim strategy.

Label directions and warnings to confirm for the destination market:

• Psyllium. A drink mix needs a water instruction. When the label uses the 21 CFR 101.81 psyllium claim and the husk is dry or incompletely hydrated, 21 CFR 101.17(f) also requires a notice on adequate fluid, choking if the product is eaten with too little liquid, and avoiding the product if swallowing is difficult.
• Glucomannan and konjac. Use the water amount, timing and choking warning in the EU claim above when that claim is requested. The water instruction is part of the label for a gel-forming konjac serving.
• Inulin and FOS. Gastrointestinal tolerance at the labeled serving, including whether the directions introduce the serving gradually.

Incoming-material checks and finished-product release criteria are defined in the approved project specification. Depending on the ingredient and product, the agreed scope may include identity, fiber content by the specified method, moisture, microbiology and heavy metals. The project specification identifies the required tests, methods, acceptance limits and release documents before production. Any external laboratory testing is confirmed by scope and quotation.

What is the MOQ for private-label fiber gummies?

Gummies are quoted for the project. Piece count, the cook trial, the assay and the pack set the minimum and the dates. Planning ranges for the other formats are in Planning Minimums and Timing.

How many grams of fiber can a gummy deliver?

The piece count and the fiber decide that. Commercial inulin readings are on Prebiotic Fiber Gummies. A gel-forming psyllium serving is generally too bulky for a standard piece.

Can psyllium be made into capsules or stick packs?

Yes, when the capsule count or the stick fill is part of the specification. A gel-forming drink is usually a powder. See Psyllium Drink Mix.

How do you test dietary fiber content?

The finished-product specification names the method and the limit. Incoming material is checked against the ingredient specification. Declared grams follow the destination market’s labeling rules. See Specification, Fiber Grams and Label Review.

What is the difference between straight-chain content and resistant starch?

Straight-chain content measures amylose, the linear fraction of the starch. Resistant starch measures starch that resists digestion in the small intestine. This grade is specified on resistant starch ≥ 40%, not on amylose. See Green Banana Resistant Starch.

How long does it take to develop and manufacture a fiber supplement?

The timeline depends on the fiber grade, the formula, the format, the packaging and the testing. A sample may be needed to confirm dispersion, viscosity, flavor or gummy texture before the specification is approved. Commercial production is scheduled after formula approval, packaging confirmation and agreement on the release requirements. Planning ranges are in Planning Minimums and Timing. The quotation states the sample and production windows for that project.