Philippines Vitamins and Minerals Classification Guidelines

The Philippines presents a significant opportunity for U.S. exporters, particularly in the health and wellness market. With a growing middle class and increasing awareness of health and nutrition, demand for dietary supplements and vitamins is on the rise. However, entering this market requires a clear understanding of the country’s regulatory landscape, especially in light of recent amendments to Philippine Food and Drug Administration (FDA) regulations. The reclassification of vitamins and minerals from “food or drug” to “food or dietary supplements” and the imposition of new limits on daily intake levels are critical considerations for U.S. manufacturers aiming to expand their presence in the Philippines.

The Philippine FDA is currently reviewing amendments to FDA Office Order No. 22 s. 1991, which reclassifies vitamins and minerals as dietary supplements rather than drugs. This shift aligns with international standards, such as those set by the ASEAN Alimentarius Commission, USFDA, and other global bodies like the World Health Organization and the Food and Agriculture Organization. The revised regulation also introduces maximum allowable daily intake limits for 26 vitamins and minerals, including Vitamin A, C, D, B1, B6, Calcium, Iron, and Magnesium. These limits are consistent with U.S. standards and aim to ensure consumer safety by preventing the risks associated with overconsumption.

For U.S. companies looking to export dietary supplements to the Philippines, these regulatory changes have significant implications. First, all dietary supplements must be registered with the Philippine FDA, a process that may differ from the U.S. regulatory system. Additionally, U.S. manufacturers must ensure that their products adhere to the new maximum daily intake limits for vitamins and minerals. Failure to comply with these regulations could result in delays, fines, or product recalls.

Labeling requirements also differ between the two countries. In the Philippines, product labels must include a warning advising consumers not to exceed the recommended daily intake. Moreover, labels may not claim that supplements can replace meals or serve as a substitute for a varied diet. This could necessitate adjustments to product packaging and marketing strategies to comply with local regulations.

As the Philippines continues to revise its regulations for dietary supplements, U.S. exporters must stay informed and ensure their products comply with local laws. The reclassification of vitamins and minerals as dietary supplements and the establishment of maximum daily intake levels reflect the country’s commitment to consumer safety and align with international standards. By adhering to these regulations and adapting their product offerings accordingly, U.S. manufacturers can successfully navigate the Philippine market and tap into its growing demand for health and wellness products.

The U.S. Commercial Service Manila can help U.S. exporters navigate the Philippine regulatory environment and expand their reach to the Philippine market.

U.S. exporters may view the draft FDA Circular here.

For more information, you may email Katrina Domingo, Commercial Specialist at email address Katrina.Domingo@trade.gov.