The global dietary supplements market, valued at a staggering USD 163,986.0 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 9.0% from 2023 to 2030. A trend powered by a growing geriatric population, a paradigm shift from pharmaceuticals to nutraceuticals, and an increasing focus on personalized nutrition. Additionally, the escalating number of fitness centers, health clubs, and gymnasiums are also contributing to this surge, augmenting the demand for energy and weight management supplements. (Source: Grand View Research)
The outbreak of the COVID-19 pandemic has considerably affected North American, Asian and European countries. However, the dietary supplement industry, largely concentrated in these regions, has capitalized on this situation, experiencing a boom in demand for immunity-boosting supplements.
But what’s hidden beneath these promising figures? The answer: an intricate maze of legalities. Yes, to successfully navigate the supplement market and sell supplements, it’s crucial to first understand the legal requirements and regulations.
In the Philippines, where supplements are increasingly gaining popularity, a License to Operate (LTO) from the Philippine Food and Drug Administration (FDA) and a Certificate of Product Registration (CPR) are mandatory. But if you think getting these is as easy as filling out an application form, think again. It’s a detailed, lengthy process that calls for a deep understanding of the legalities involved. And a single error can cause significant delays, affecting your plans to step into this profitable market.
So, how to sell supplements while keeping these legal requirements in check? Let’s dive deeper.
Understanding the Basics: What License Do You Need To Sell Supplements?
When it comes to selling supplements, the first question that pops up is, “What license do you need to sell supplements?” The answer lies in acquiring two critical documents: a License to Operate (LTO) and a Certificate of Product Registration (CPR) from the FDA. These are your legal passes to stepping into the world of selling supplements, be it online or offline.
But here’s the catch: the process isn’t straightforward. Many supplement brand owners, new to the industry, often believe that acquiring these licenses is a simple step-by-step process. In reality, it’s not. It’s a complex procedure that, if not handled correctly, can result in setbacks, putting your business plans on hold. That’s where expert assistance can prove to be an advantage. The professionals, with years of experience, not only guide you through the process but also ensure efficiency, sparing you from the hassle of understanding and dealing with the legalities.
Now that we understand the need for an LTO and a CPR, let’s walk through the steps involved in acquiring them.
How To Start Selling Supplements: Getting Your LTO
Embarking on your journey to sell supplements starts with securing a License to Operate (LTO). This license, issued by the Philippine FDA, is a formal declaration that allows your business to legally manufacture, import, export, distribute, or sell health supplements.
The process to acquire an LTO might seem daunting, but with a clear understanding and the right guidance, you can navigate through it smoothly. Let’s break down the process: The LTO is obtained via FDA’s E-LTO application, a digital application platform provided by the Philippine FDA. The steps and timeline are as follows:
Evaluation (25 days): After you submit the application, it enters the evaluation stage. During this period, the FDA’s evaluator reviews the application in accordance with Administrative Order 2016-003, “Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.” Should there be any deficiencies in the application, an automatic notification will be sent for compliance.
Checking and Quality Assurance (4 days): Once the application passes the evaluation, it’s forwarded to the FDA checker and Division Chief for Quality Assurance. These officials vet the application and its recommendations before it’s approved by the Center Director.
Approval (1 day): The Center Director provides the final decision on whether to issue the LTO to the applicant.
Throughout this process, it’s important to note that any simple error in your LTO application can cause significant delays. Hence, it may sometimes be worth it to leave this process to professionals who have years of experience and can execute it more efficiently.
Next up, after securing your LTO, is obtaining your Certificate of Product Registration (CPR), which further validates your right to sell health supplements.
Certificate of Product Registration: Ensuring the Quality of Your Supplements
The process to acquire a CPR is detailed but comprehensible. Let’s walk through it:
Application (0 days): The first step is to enter the FDA’s portal (https://eservices.fda.gov.ph/applications) and accurately fill up the online form.
Payment (2 days): The next step involves paying the assessed fee, as per the system-generated Order of Payment Form, through the FDA’s cashier or other payment methods such as Bancnet, Landbank.
Evaluation (48 days): Once the application is submitted and payment is confirmed, it enters the evaluation stage. Here, the evaluator examines your application and provides a recommendation for either denial or approval.
Checking (40 days): After the evaluation, the application moves on to the checking stage, where the checker reviews the evaluated application and the recommendation provided.
Issuance (20 days): The CFRR Director then reviews the application and electronically signs it. If deficiencies are found in the application, the applicant will receive a letter of denial.
Printing of CPR (4 days): Upon approval, the assigned administrative staff prints the system-generated CPR. They then update the e-registration, forward the CPR to the releasing section, and finally, the CPR is released to the applicant.
Just like with the LTO process, common pitfalls in the CPR process are making errors and missing requirements in the application. These mistakes and insufficient documentation can lead to significant delays in approval or even outright denial. This underlines the importance of meticulousness when filling out the application or, better yet, leaving it to professionals who are well-versed in the process.
Knowing how to sell health supplements legally is half the battle won. The next half is understanding how to transition from physical to digital sales. In the next section, let’s explore how to sell supplements online while maintaining strict compliance with regulations.
How To Sell Supplements Online: Ensuring Compliance in the Digital Space
The digital era has brought with it a tide of opportunities, one of which is the convenience of selling and purchasing products online. The world of dietary supplements is no exception. With the click of a button, consumers can have vitamins, protein powders, herbal supplements, and more delivered to their doorstep. The surge in online supplement sales has been astronomical, particularly as more consumers prioritize health, wellness, and convenience.
However, as with any significant shift in commerce, the rise of online supplement sales comes with its own set of challenges. The primary challenge? Ensuring that the sale of these products online remains compliant with existing regulations.
The Virtual World, Real Regulations
It’s a common misconception that the virtual marketplace is the ‘wild west’ when it comes to regulations – that it’s somehow less stringent or easier to navigate than brick-and-mortar sales. This couldn’t be further from the truth. The FDA’s regulations regarding the sale of supplements apply universally, regardless of whether transactions occur in person or online. This means that every health supplement you sell online should have the necessary LTO and CPR, just as if you were selling it in a physical store.
Why Compliance Matters, Especially Online
In light of the pandemic, the Philippine FDA noticed a proliferation of unregistered products in online marketplaces such as Shopee and Lazada. To clamp down on these non-compliant items, they issued public advisories, informing the general public about specific products being sold on these platforms without proper FDA registration. These online marketplaces are continuously monitored, and any companies or individuals found selling unregistered food supplement products online can face cease and desist orders from the FDA.
This underlines the importance of obtaining an LTO and CPR before selling supplements, even online. These legal documents are not just a way to comply with regulations, but they also help to gain the trust of consumers. They are an indication that you prioritize the quality and safety of your products.
Furthermore, in the digital realm, you must also ensure that your online platform adheres to additional laws surrounding data privacy, digital advertising, and consumer rights. It might seem overwhelming to keep up with these regulations, but they exist to safeguard both businesses and consumers. Together, they contribute to a secure and trustworthy online marketplace for health supplements.
The prospect of navigating these requirements might seem daunting, but remember, you don’t have to go through it alone. In the next section, we’ll discuss how a trusted partner like VBC can help simplify this process for you, allowing you to concentrate more on growing your online business.
Making It Easier: How VBC Can Assist
Diving into the world of supplements is a rewarding journey, but it’s clear that understanding and complying with the legal requirements can be quite challenging. From obtaining your LTO to getting your CPR, the process involves numerous steps and potential pitfalls. Not to mention, as you expand into online sales, staying on top of digital compliance can be equally daunting. So, where does one turn for help in navigating these hurdles? That’s where VBC comes in.
As a one-stop shop toll manufacturer in the Philippines, we have decades of experience obtaining LTO and CPR, not only for our company but also for hundreds of our customers. Our deep understanding of the regulations, our familiarity with the application process, and our knowledge of common mistakes allow us to guide our customers smoothly through each step.
Our team doesn’t just assist with the paperwork. We understand that as a business owner, your time is valuable. By taking on the burden of dealing with FDA regulations on your behalf, we allow you to focus on what you do best: running your business and selling your supplements. Our goal is to make the process as seamless as possible. We uphold a customer-centric approach, consistently updating you at every step of the process, enabling you to focus on your core operations. Our service extends beyond just LTO and CPR paperwork – we tap into our specialty in the diverse field of supplement production and formulation. While we’re recognized as a leading tablet manufacturer, our expertise isn’t limited to that format. We also excel in the creation of high-quality liquid, powder, capsule, and softgel supplements. Our comprehensive skills ensure your products meet market demands and abide by stringent regulations.
But why stop there? The path to a successful supplement brand extends beyond just compliance. In the next section, we’ll discuss the opportunities that lie ahead once you’ve secured your LTO and CPR and how to make the most out of selling health supplements.
How To Sell Health Supplements: Success Beyond Compliance
Navigating the intricate web of regulations and legalities is undoubtedly a pivotal aspect of establishing a foothold in the supplement industry. But true success? That transcends mere compliance. It’s built on the pillars of quality, trust, and a brand’s commitment to delivering genuine value to its consumers.
When we talk about the success of a supplement brand, the narrative isn’t limited to fulfilling the necessary legal prerequisites. Yes, securing your License to Operate (LTO) and Certificate of Product Registration (CPR) lays the foundation. However, to truly resonate with consumers and leave an indelible mark in the market, brands must journey beyond the confines of compliance.
First and foremost, it’s essential to recognize that consumers are becoming increasingly discerning. In the digital age, information is readily accessible. As a result, today’s consumers are more informed and demand transparency, quality, and genuine health benefits from the supplements they consume. Achieving this requires a deep-seated commitment to product quality, backed by rigorous testing, research and development.
Furthermore, successful branding is crucial. It’s not enough to have a product on the shelf; it’s about how that product communicates its value proposition. This involves thoughtfully crafted marketing strategies, customer education, and consistent brand messaging. In essence, while regulations ensure you’re in the game, your brand’s unique value and ethos determine how well you’ll play.
Enter VBC. Our extensive experience in the industry positions us as more than just a regulatory guide. We’re here to be your strategic partner, assisting in navigating the complexities of the FDA and realizing your brand’s full potential through innovative product formulations and top-notch production of high-quality supplements. By choosing to collaborate with VBC, you’re not just ensuring a smoother entry into the market; you’re tapping into a reservoir of industry insights, expertise, and best practices that can propel your brand to the forefront.
Whether you’re a seasoned player or a budding entrepreneur eager to make a mark in the supplement domain, remember: Compliance is your starting line, not the finish. The race to success is ongoing, demanding perseverance, innovation, and an unwavering commitment to excellence.
Are you ready to embark on this journey toward unparalleled success in the supplement industry? If so, VBC is here to accompany you every step of the way. Reach out to us and discover how, together, we can chart a course that not only meets regulations but also resonates with consumers, ensuring your brand’s longevity and prominence in the market. The world of health supplements awaits your breakthrough; let’s make it happen together.
Unlock the potential of the thriving health supplement market with VBC’s expert guidance. Discover what license you need to sell supplements, how to start selling supplements online, and achieve success beyond compliance. Embark on your journey today and start exploring our insightful blogs now!!