The main changes to current rules focus on revising the maximum limits for vitamins and minerals, with minimum levels for vitamins and minerals increasing from 20 to 30% of the RDI per unit (one tablet, one capsule, one tablespoon or other).
The vitamin and mineral content in dietary supplements also may not exceed the levels of No Observation of Adverse Effects (NOEA), stated the consultation document.
ANMAT defines supplements as products intended to increase the usual dietary intake of nutrients and other ingredients in healthy – and not diseased – people. The products must be orally administered and may be presented in different forms, including tablets, capsules, granules, powders, liquid drops, solutions, or other forms for gastrointestinal absorption.
All dietary supplements products must be manufactured according to good manufacturing practices (GMPs) and sold in packaging that guarantees the quality and stability of the products.
“They must contain, in simple or combined form: amino acids, proteins, lipids, carbohydrates, probiotics, vitamins, minerals and / or fibers.”
According to the proposed regulatory updates, the permitted botanical list could be cut from 35 to 27 species.
Only the use of these herbs and / or botanicals will be allowed when:
a) there is documented evidence of its physiological and / or nutritional role,
b) its physiological and / or nutritional role is related to the main nutrients responsible for the framing as a dietary supplement, and
c) its concentration of use in the product has no therapeutic indication or is applied to pathological states.
Protein & fish oil
For protein supplements, ANMAT states that these should cover no less than 30% of the RDI for protein per unit.
For fish oil supplements, the EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) content should be no less than 6% each. When made with fish oil concentrates (or concentrates from other marine organisms), these must have an EPA and DHA content no less than 15% and 10%, respectively.