Beyond the label: Understanding nutraceuticals (premium supplement grade and detary supplement grade)

Setting a new standard for transparency and quality in personalized wellness

In a world where health and wellness options seem endless, quality isn’t just something we want; it’s something we need. But when it comes to choosing a nutraceutical, how can you tell what truly sets one product apart from another?

At Medisca, that’s the question we’ve set out to answer.

As compounding and wellness continue to evolve, so does the demand for quality. Since 2014, Medisca has supported this shift through our nutraceutical offerings, helping healthcare professionals deliver reliable, wellness-based solutions as part of a more integrative approach to care. To advance this mission, we are pleased to introduce a newly defined category, known as our “premium supplement grade (“PSG”).” We are setting a new standard in personalized wellness and nutritional therapy, one that delivers enhanced quality, greater transparency, and empowers informed choice.

If you're looking to enhance your knowledge, LP3 Network is launching an upcoming webinar series focused on sterile compounding requirements, product qualification, and the role of complementary treatments in personalized wellness.

But before we dive deeper, let’s take a closer look at what nutraceuticals are, and why they matter.

Why now?
With the rise of telehealth and the growing emphasis on integrative wellness, nutraceuticals are playing a more central role in personalized treatment plans. This growth has also drawn greater attention from regulatory bodies and raised expectations among healthcare professionals and patients alike. In response, Medisca developed a classification system that brings greater clarity to sourcing decisions and sets a new benchmark for transparency and quality across the board.

Raising the standard in nutraceuticals

At Medisca, we offer two distinct nutraceutical grades, each defined by its level of regulatory oversight, testing requirements, and manufacturing standards.

Our dietary supplement grade products are produced under the supervision of food and health authorities, while our premium supplement grade products are manufactured in FDA-registered and listed drug manufacturing facilities. Our Qualified manufacturers adhere to FDA registration and listing requirements and comply with general facility and equipment-specific finished pharmaceutical cGMP standards (21 C.F.R. Parts 210 and 211). Compliance with stability testing may vary. Any differences between product-specific cGMP standards and the Pharmaceutical/Premium Grade Supplement are indicated on each individual product specification

Here’s a closer look at what sets each grade apart:

Dietary supplement grade
For over a decade, our nutraceutical offerings have served as trusted, high-quality options, meeting recognized industry standards such as ISO certifications and FDA Food Facility Registration.

Crafted under well-established guidelines, these products emphasize safety, consistency, and effectiveness, making them a reliable choice for daily wellness support.

Premium supplement grade
Our premium supplement grade nutraceuticals are held to an even higher standard. Manufactured in FDA-registered drug manufacturing facilities, they are tested to pharmaceutical-grade specifications relating to formulation, packaging, labeling, and storage.

This isn’t just a new label, it’s a new benchmark in quality and transparency. With full visibility into sourcing, manufacturing, and testing, you gain the confidence to make informed, high-quality choices.

The result? More clarity, more control, and more confidence in selecting the product that best fits your needs.

Today, approximately 60% of our nutraceutical portfolio falls under Dietary Supplement Grade, 37% under Premium Supplement Grade, 4% under excipient, and 2% under API. As part of our commitment to quality, we are actively working to increase the number of products meeting the highest-grade standards wherever possible.

Making sense of nutraceuticals: Your top questions answered

Can a premium supplement grade be used in preparing various dosage forms and compositions, including non-sterile and sterile?

As with any ingredient, the suitability and appropriateness for use in a given case is a function of a thorough review of the manufacturer documentation, specifications, and required testing, etc. Whether a premium supplement grade can be used in a sterile preparation depends on the end user's internal qualification process, risk assessment, a thorough assessment of the material’s quality, and its suitability for the intended use. From a qualification standpoint, the primary differences between a premium supplement grade and an active pharmaceutical ingredient lie in the vendor quality agreement and Medisca-conducted stability testing. These are the key factors that distinguish the two in terms of regulatory and quality expectations.

Despite these differences, both product types share several quality attributes:

• Sourced from FDA-registered drug manufacturing facilities
• NDC-listed (National Drug Code)
• Subject to full compendial testing annually and testing for residual solvents and elemental impurities every two years using validated methods.

Can a dietary supplement grade be labeled as USP?
Yes, if it meets the specifications set out in its corresponding dietary supplement monograph.

USP (United States Pharmacopeia) refers to a monograph standard that outlines identity, strength, quality, and purity requirements. It applies to a wide range of substances, including active pharmaceutical ingredients (drug substances), excipients, and certain dietary supplements.

A dietary supplement can carry a USP designation if it fully complies with its corresponding USP dietary supplement monograph. This designation reflects that the product meets all specifications, as defined by the monograph. The Medisca premium supplement grade includes additional rigor in the qualification process, as mentioned above, offering a higher level of assurance and qualification for compounding professionals.

What’s next in our quality journey
Over the coming months, you’ll see these classifications reflected across our platform, including product pages, Safety Data Sheets (SDS), Certificates of Analysis (CofAs), and product labels. While updates to digital assets will be implemented sooner, label transitions may take more time. These efforts are part of our broader initiative to enhance transparency and support informed decision-making at every step.

This evolution is already underway, with recent additions like NAD+ (3315) and Ascorbic Acid – Tapioca Source (3310) joining our Premium Supplement Grade line. These represent just the beginning of our expanding high-grade nutraceutical offerings.

Explore our full nutraceutical catalog and learn more about how each grade supports smarter, more personalized care.

Have questions about which nutraceuticals are right for your practice?
Speak to one of our experts for tailored support and trusted guidance. Contact us.