In the US, the FDA allows an authorised health claim linking soluble fibre from psyllium husk, as part of a diet low in saturated fat and cholesterol, to a reduced risk of coronary heart disease. The product must meet set conditions, including a minimum amount of psyllium soluble fibre per serving.
In the EU, a food may carry only the nutrition and health claims allowed under Regulation (EC) No 1924/2006 and listed in the EU register. A claim allowed in the US does not carry over. Claims rules change, so confirm the current position with a regulatory adviser before you print.
Food, supplement or medicine
The first question is what your product legally is. The same husk can be sold as a food ingredient, a dietary or food supplement, or a medicine. Laxative claims are medicinal claims in many markets.
- US: bulk-forming laxative claims fall under FDA's over-the-counter drug rules, not food rules.
- EU: psyllium sold for laxative use is often regulated as a herbal or traditional medicine, which needs its own authorisation.
- Food and supplement labels in both regions must avoid claims to treat, cure or prevent disease, apart from authorised health claims.
United States
- Health claim: the authorised psyllium and heart disease claim has fixed wording elements and conditions. Check the current FDA rule for the minimum soluble fibre per serving and other criteria.
- Dietary fibre: FDA has accepted psyllium husk as a fibre that can count towards dietary fibre on the Nutrition Facts label. Confirm current FDA guidance for your product.
- Nutrient content claims: terms such as "good source of fiber" or "high fiber" have defined thresholds per serving.
- Structure and function claims on supplements, such as supporting regularity, need substantiation and the standard FDA disclaimer.
- Warnings: FDA requires choking and fluid intake warnings on some psyllium products. Check which apply to your format.
European Union
- Nutrition claims: "source of fibre" and "high fibre" are allowed if the food meets the thresholds in the regulation's annex.
- Health claims: only authorised claims in the EU register, with their exact conditions of use, may be used. Search the register for any entry that names psyllium or the relevant fibre before relying on a claim.
- Claims not in the register, or refused, must not be used on food labels or in advertising.
- Food supplements also follow EU food supplement rules and each member state's notification process.
United Kingdom and other markets
Great Britain now keeps its own register of nutrition and health claims, which started from the EU list but can differ. Canada, Australia and New Zealand, and Gulf states each have their own rules. Do not assume one label works everywhere.
What your Indian supplier can and cannot do
Your supplier can confirm the product facts behind a claim: purity, soluble fibre data, and test results from an accredited lab. They cannot make a claim legal in your market. A certificate of analysis that states fibre content does not by itself support a health claim.
If you rely on a minimum fibre level for a claim, put it in your specification and test it on each lot. The grade you buy affects fibre content, as explained in what the purity grades 85%, 95%, 98% and 99% mean. If an Indian packer prints your retail packs, see whether Indian suppliers can pack psyllium in retail capsules or sachets.
How we help
We do not give regulatory or legal advice on claims. We make sure the product matches what your claim relies on, by writing it into the spec and testing each lot at an NABL-accredited lab. Ask for a free sourcing review.