Gummy supplements, from formula to delivery

What we make

• Pectin gummies, plant-based, for a vegan range.
• Gelatin gummies.
• Sugar-free gummies.
• Centre-filled or coated gummies, for a second texture or a finish.

Gummies are popular for vitamin C, elderberry, apple cider vinegar, kids' multivitamins, and sleep and relaxation.

Medicine or food?

A gummy is a medicine or a food the same way a capsule is: by what it contains and how it's presented, starting with its claims (medicine, food or cosmetic?). Two rules settle most gummies.

• Added vitamins and minerals. In a general food, a vitamin or mineral can only be added to a food listed in Schedule 17 of the Food Standards Code (section S17-4): cereals and cereal products, dairy products, edible oils and spreads, extracts, juices and cordials, plant-based analogues, soups and formulated beverages. Confectionery isn't on the list. A vitamin gummy is made as a listed medicine instead, which is why Complementary Medicines Australia tells parents to buy only gummies with an AUST L number on the label.
• A claim about health. A gummy that claims a therapeutic benefit is presented as a medicine. One with no added vitamins or minerals and no therapeutic claim can be a food, with its claims held to the food rules. More on the food pathway.

Making a gummy as a medicine

A gummy listed on the ARTG is held to the same rules as any other listed medicine. Every ingredient has to be in the Permissible Ingredients Determination, and every claim has to be a permitted indication backed by the sponsor's evidence (permitted indications). It's made at a site licensed by the TGA, or one holding TGA GMP clearance if it's overseas (choosing a supplement manufacturer). The first run is at least 3,000 finished retail packs, as for any format (what a supplement costs to develop).

The label

The label follows TGO 116, like any listed medicine's. Two lines matter more for gummies than for most formats.

• Sugar alcohols. An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry "Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea". That's worth checking on a sugar-free gummy.
• Iron and child-resistant packaging. TGO 95 requires child-resistant packaging for listed medicines containing certain substances in set strengths or pack sizes. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. That's worth checking on a kids' multivitamin gummy.

More in our supplement labelling guide.

Taste, texture and shelf life

Taste drives repeat purchase, so a gummy is tested for how it tastes and chews across its shelf life, as well as for its actives. The stability program supports the expiry on the label: what the TGA expects is in our stability testing guide. When the dose is high, a tablet holds more in one unit (capsules, tablets and softgels), and a large serve suits a powder.