The new framework, currently in draft form, is set to replace existing guidelines that have been in place since 1991, where existing arrangements currently categorise these nutrients as either a food or drug.
“After thorough review and evaluation, and to keep pace with the advances in energy and nutrient requirements, the Food and Drug Administration of the Philippines (FDA) shall use the different international references in setting the limits of vitamins and minerals,” the guidelines state.
“The establishment of limit of vitamins and minerals in food/dietary supplements aims to ensure that the manufacturers use safe levels of vitamins and minerals in their products. Thus, use of the products under the instruction or direction for use provided by the manufacturers will be safe for the consumers.”
Revised maximum values for vitamins A and C, and folic acid
Revised maximum levels of vitamin and minerals for adults include vitamin A or retinol (1,500 microgram [μg] recommended energy intake per day); vitamin C (1,000 mg/day); folic acid (0.9 mg/day); and vitamin K (120 μg/day).
For vitamin K, the FDA referred to the vitamin K1 and/or vitamin K2 form, where the intended use was via the oral format of a multivitamin or mineral preparation for adults and not as a single ingredient.
The FDA also recommended that the label should contain the advice: “Consult a healthcare practitioner prior to use if you are on anticoagulant therapy or taking blood thinners such as warfarin.”
The guidelines go on to clarify specific labelling requirements, in which food/dietary supplements should contain advice to the consumer to avoid exceeding the maximum recommended use per day. The label should not contain any statement or implication that supplements can be used to replace meals or a varied diet.
Food/dietary supplements form only part of the diet of consumers
Other revised maximum levels of vitamin and minerals for adults include vitamin D (25 mcg/day); calcium (1200 mg/day); iodine (150 mcg/day); and zinc (15 mg/day).
The guidelines pointed out that as supplements formed only part of the diet of consumers, the levels of vitamins and minerals should not reach the maximum levels as other sources of nutrients from the diet were expected to contribute to nutrient intakes.
“This is to ensure safety and protect consumers as the amount beyond the upper levels of vitamins and minerals will pose adverse health effects,” the FDA stated.
Transition period built in to guidelines to ease pressure on supply chain
The new framework also revealed details of a transition period enabling manufacturers, traders, importers and distributors of food/dietary supplement products to adapt to the new rules.
Here, all affected supplements that need to reformulate and have a valid certificate of product registration (CPR) will need to file for initial application. CPRs with less than a year of validity will be renewed for a maximum of two years, provided they are qualified for renewal, to give time for reformulation, after which, an initial application shall be filed.
In cases where there are still existing label stocks that adhere to current CPR, a request for an "exhaustion" may be filed, where an inventory of remaining stocks must be declared for a maximum period of six months.
