New regulatory framework for food supplements
Highly expected by the sector, the new regulatory framework for food supplements (IN 28/18) brings advances such as the reclassification of a significant part of specific medicines, based on amino acids, vitamins and minerals to the new category of food supplements.
However, the new rules require a lot of attention from the companies that own products currently classified as specific medicines based on amino acids, vitamins and minerals, as they will require some adaptation of practically all products:
The first point is to assess whether your medicine will remain as a specific medicine or whether it will migrate to the new category of dietary supplements. For this, the company must:
· Check if the medicine's assets are covered and within the range provided by IN 28/18
· Assess whether the claim established for the product is in accordance with the indications and the product's market positioning is included in IN 28/18.
If the product has indications other than those provided for in IN 28/18 or constituents above the recommended range, it will remain in the category of specific drugs, but it should be done within 60 months (until June / 2023) (except for those already for therapeutic indication with subject code 11362 - Specific proof of safety and efficacy - RDC242 / 2018. The proof must be carried out following the provisions of article 32 of RDC 24/2011:
Art. 32 The technical report must contain information on safety and efficacy proven by:
I - pre-clinical and clinical safety and efficacy report; or
II - data from technical-scientific literature that includes this information; or
III - traditional use;
Note: For products that have already presented the items above, the steps above must be followed and the justification and indication of the file of the petition evaluated and approved by Anvisa in which the aforementioned proof has already been submitted must be presented.
If the product fits as a food supplement, the second step is to check if the excipients in its formula are included in RDC 239/18 which establishes the food additives and technology aids authorized for use in food.
If there is any excipient not foreseen, the company must request inclusion in the list following the established in RDC 16/1999. If this is the case for you, do it as soon as possible, because only after adding your ingredient to the list of food additives and adjuvants, the company will be able to adapt its product to the category of dietary supplements, and 5 years can go by quickly. This approval of the new ingredient can be carried out in conjunction with product registration.
Inovatie has extensive experience in the preparation of efficacy and safety reports for medicines, including those based on literature, and if needed we are available to prepare a budget.
Below is a summary of the new legislation published. And if you need help, do not hesitate to contact us even to prepare the safety and effectiveness report for your product.
Establishes authorized food additives and technology aids, including infants and young children.
Changes the categories of food dispensed/registration required. Ex. Extinction of the categories "food for pregnant women and nursing mothers" and "food for athletes". Mandatory registration of food supplements containing enzymes or probiotics.
Establishes requirements for proving the safety and health benefits of probiotics.
Regulates the registration of vitamins, minerals, amino acids and proteins for oral use classified as specific medicines, re-framing a part as food.
Creates the category of "food supplements". Establishes an adaptation period of 60 months.
Revoked the obligation for specific drugs to express the percentage of each asset based on the IDR.
Proof of validity through stability studies. It does not detail the criteria of the stability study.
It starts to allow over dosing, as long as it does not exceed the maximum limits established.
Labeling must show “This product is not a medicine”, “Do not exceed the daily consumption recommendation indicated on the packaging” and “Keep out of the reach of children”.
Establishes lists of constituents, usage limits (minimum and maximum), claims and supplementary labeling.
Update of the concept of IDR (Recommended Daily Intake) from “single value”, to “recommended range”.
Expansion of authorized claims, including "does not contain ...", "low in ..."
Provides for the health requirements of food supplements.
It defines what a food supplement is: a product for oral ingestion, presented in pharmaceutical forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, isolated or combined.
Lists substances that are not allowed in the composition of dietary supplements. Ex: partially hydrogenated oils and fats.
It innovates by incorporating the need for stability studies, without, however, detailing the specific requirements.
It allows overdose, as long as it does not exceed the limits of IN 28/18.
The sector is still waiting for the publication of the standard for food stability, which, depending on what is approved, can be quite impactful.