The Philippines is looking to overhaul its 33-year-old regulation on vitamins and minerals, reclassifying these products as food or dietary supplements, as well as the daily limits per person.
This marks a significant shift from the current classification, where these products are categorized as either food supplements or drugs. The new framework, currently in draft form, is set to replace existing guidelines that have been in place since 1991,this new regulation is still pending on the outcome of a PUBLIC CONSULTATION
Understanding the New Regulations
The reclassification of 26 vitamins and minerals as food or dietary supplements.
Products must meet specified maximum daily limits to ensure consumer safety. Example: The new framework, officially titled the “Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product,” introduces clear guidelines on the maximum daily limits for 26 essential vitamins and minerals. For example, the daily limit for vitamin C is set at 1,000mg, while vitamin D has a maximum daily limit of 25 mcg. These limits are designed to prevent overconsumption and potential toxicity.
The label must include the caution statement: "Consult a healthcare practitioner prior to use if you are on anticoagulant therapy or taking blood thinners such as warfarin."
For vitamins and minerals without maximum daily limits set by the FDA and no known hazards at high intakes, companies must submit scientific data on their maximum intake levels to the FDA.
All vitamin and mineral products must also include a warning for consumers not to exceed the maximum limit stated on the label.
Under the current classification, vitamins and minerals labeled as drugs can have a strength or concentration per dosage form exceeding 105% of the recommended dietary allowance (RDA) for fat-soluble vitamins and more than 150% of the RDA for water-soluble vitamins.
If classified as food supplements, the strength or concentration per dosage form must be less than 105% of the RDA for fat-soluble vitamins and less than 150% of the RDA for water-soluble vitamins.
The new guidelines were developed based on standards from CODEX and regional policies observed in Southeast Asia, Europe, and the US, according to the FDA.
"After a thorough review and evaluation, and to keep up with advances in energy and nutrient requirements, the FDA will use various international references to set the limits for vitamins and minerals. These references include the Association of Southeast Asian Nations (ASEAN), Codex Alimentarius Commission, Food and Agriculture Organization/World Health Organization (FAO/WHO), European Food Safety Authority (EFSA), and the USFDA, among others," the agency explained.
The FDA aims to ensure that manufacturers use safe levels of vitamins and minerals in their products by establishing maximum daily limits.
Additionally, the FDA stated that vitamins and minerals classified as food or dietary supplements must be in the form of capsules, tablets, liquids, gels, powders, or pills. They should not be available in parenteral forms, sublingual forms, or other methods not taken directly into the mouth.
Proposed Implementation and Compliance Period:
The Food and Drug Administration (FDA) Philippines will oversee the implementation of these new regulations. and there will be a transition period allowing manufacturers to adjust and comply with the new standards.
Companies with Certificates of Product Registration (CPRs) expiring within five years of the new guidelines being introduced must submit their reformulations before their current CPRs expire.
For companies whose CPRs expire in less than a year, the FDA will extend their existing CPRs for up to two years for companies to reformulate and submit registration that they comply with new regulations.
Implications for Manufacturers
For manufacturers, this regulatory change represents both a challenge and an opportunity. On one hand, they must invest in product reformulation, re-labeling, and possibly even re-registering products with the FDA. This process involves significant cost and effort, especially for smaller businesses.
On the other hand, aligning with these new standards can enhance product credibility and consumer trust. Products that meet these new guidelines will be seen as safer and more reliable, potentially boosting sales in a market where health consciousness is rapidly growing.
Benefits for Consumers
Consumers stand to gain the most from these regulatory changes. With clearer guidelines and stricter enforcement, the risk of consuming excessive amounts of vitamins and minerals is significantly reduced. This is crucial in a market where dietary supplements are increasingly popular and widely available.
Moreover, consumers will have access to products that meet international safety and quality standards, providing peace of mind and ensuring that their health is not compromised by substandard or potentially harmful supplements.
The Role of International Standards
By adopting standards from international bodies such as the Codex Alimentarius Commission and the European Food Safety Authority, the Philippines is taking a significant step towards harmonizing its regulations with global norms. This not only facilitates international trade but also ensures that consumers in the Philippines have access to the same quality of supplements as those in more developed markets.
How Protech Solutions Can Help?
In Protech Solutions we specialize in the production of packing and processing machinery for the International nutraceutical, food, and food supplements, cosmetics, and pharmaceutical industries, from one machine to the entire production line, and we can assist Nutraceutical manufacturers in the Philippines adapting to these new regulations faster. Here’s how we can help:
Advanced Production Lines:
Our production and counting capsule lines ensure precise formulation and dosage control, helping manufacturers comply with the new maximum daily limits for vitamins and minerals.
We offer customizable machinery solutions tailored to meet specific production requirements and regulatory standards.
Quality Assurance and Control:
Our machines are equipped with advanced quality control systems to ensure that every batch of supplements meets the highest standards of safety and efficacy.
Our Machines productions follow GPM guidelines.
Efficient Packing Solutions:
Our packing machines are designed for efficiency and reliability, ensuring that products are safely and accurately packaged.
We offer solutions for various packaging types, including bottles, blister packs, and sachets, and more for diverse market needs.
Technical Support and Training:
We provide comprehensive technical support and training to ensure that your staff is well-equipped to operate and maintain our machinery.
Our team of experts is available to assist with installation, calibration, and troubleshooting, ensuring smooth and efficient production processes.
By partnering with us, nutraceutical manufacturers in the Philippines can confidently navigate the regulatory landscape and deliver high-quality, compliant products to their consumers.
Looking Ahead: Opportunities and Challenges
If The replacement of the 33-year-old vitamins and minerals regulation in the Philippines is successful it will mark a significant milestone in the country’s approach to dietary supplements.
As Nutraceutical manufacturers adapt to the new standards, the market will likely see an influx of high-quality, safe, and effective products. This, in turn, could drive increased consumer confidence and demand, fueling further growth in the sector.
Nutraceutical Manufacturers in the Philippines that can navigate the regulatory landscape effectively will be well-positioned to capitalize on the growing health and wellness trend among Filipino consumers. Strategic investments in product development and compliance will be crucial for long-term success.
What do you think about it? Should the new regulations of Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product proposed by the FDA be implemented or should the Philippines keep the 33 years old actual regulations?
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