Dietary Supplement Quality Assurance at Fullscript: New Supplement Brands & Product Handling

At Fullscript, your health and safety are a top priority. Each brand and product offered in Fullscript’s catalog must meet strict quality and safety standards, which provide you with peace of mind when selecting supplements. With so many options available, it can be challenging to choose the ideal supplements for you or your patients. Fullscript makes it easy to access the information you need regarding supplement quality by providing transparency regarding all of the brands offered in the catalog. Continue reading to learn more about Fullscript’s vetting process and quality standards.

Why is supplement quality important? 

The Food and Drug Administration (FDA) and Health Canada are the government organizations that oversee the regulation of dietary supplements and natural health products in the United States and Canada, respectively. (1)(4) However, dietary supplements are not as strictly regulated as pharmaceutical medications and the regulation of supplements is largely conducted post-market. Responsible parties, such as Fullscript, help fill the gaps in pre-market supplement regulation to help consumers feel confident about the products they purchase.

If the production and distribution of a product do not adhere to strict manufacturing standards, often reviewed by a third-party certifier, the product may include incorrect or adulterated ingredients, display inaccurate labels, and risk cross-contamination with other ingredients or microbiological contamination, among other critical issues that may affect product quality, and ultimately, consumer health. (4)

When considering supplement quality and safety, many dietary supplement manufacturers assess products using a set of standards known as Good Manufacturing Practices (GMPs). These standards consider the identity, purity, strength, and composition of the products that are being manufactured. (4)

Did you know? In the U.S., FDA regulates dietary supplements under a framework established by the Dietary Supplement Health and Education Act of 1994 (DSHEA). (8)

Good Manufacturing Practices (GMPs)

Good Manufacturing Practices are standards implemented by the FDA and developed with the intent to protect consumers and allow supplement manufacturers and resellers of supplements to eliminate the presence of unsafe and incorrect ingredients in their products. The GMP standards also ensure that products are labeled and packaged accurately, and are produced without contamination. (4) 

Good Manufacturing Practices (GMP) is sometimes referred to as Current Good Manufacturing Practices (cGMP). (2) The Current Good Manufacturing Practices serve as a guideline to supplement manufacturers and distributors to maintain up to date equipment, technologies, manufacturing processes, and policies. (2)

cGMPs exist to help ensure that supplements are produced consistently and meet specific quality and safety standards. (11) To be cGMP-certified, manufacturers must adhere to the following standards:

1. Places – locations where products are manufactured and stored are sanitary
2. People – employees are trained on proper cleanliness and safety processes
3. Processes – consistent operations are in place to provide authenticity and safety
4. Products – products are checked throughout manufacturing, storage, and delivery for authenticity, safety, and accuracy

cGMP certification comes from a third-party audit, in which a manufacturer’s standard operating procedures (SOPs), documentation systems, and manufacturing processes are evaluated against cGMP standards. cGMP certification is the baseline requirement for all brands in the Fullscript catalog. 

Adding new brands at Fullscript 

To ensure the catalog provides the highest quality products to providers and patients, Fullscript partners with the top professional-grade brands that are compliant with cGMP standards. All brands available in the Fullscript catalog undergo a thorough vetting process, so you can be sure that all products offered are manufactured with safety and quality in mind. 

Fullscript maintains the most comprehensive catalog in the industry and works to ensure that all brands meet strict policy and manufacturing standards before any brand or product is added to the catalog. The process for bringing on new brands involves an in-depth supplement quality control assessment that includes the review of the following:

• Current cGMP certifications for all manufacturers associated with the brand
• FDA facility registrations
• FDA citations, including 483s or Warning Letters
• 3PLs (Third Party Logistics) quality documentation
• Prop 65 compliance
• Recall procedures 
• Product complaints procedures
• Certificate of Analysis (COA) for finished products that include potency and identity of active ingredients, heavy metals and other contaminants
• Shelf life stability data for finished products
• Product label regulatory review

In collaboration with Fullscript’s Medical Advisory Team, the Quality Assurance team has established the Fullscript Quality Assessment, a comprehensive evaluation that allows brands to identify any measure taken that exceeds the basic quality standard requirements. This process not only applies to new brands, but existing brands as well. Fullscript also requires current brands to maintain 3rd party cGMP certification to further establish themselves as reputable supplement brands and to demonstrate their commitment to produce high-quality and safe products.

Examples of common third-party cGMP certifications include the following:

• International Organization for Standardization (ISO) 9001 (3)
• NSF International (6)
• Natural Products Association (NPA) (5)
• SGS (General Society of Surveillance) (7)
• Underwriter Laboratories (UL) (9)
• USP (13)

New Product Review

Starting in 2026, all new products added to the catalog are reviewed by the Quality Assurance and Medical teams. Only brands that provide proof of current third party cGMP certification are eligible for submitting new products. The Fullscript team reviews each product’s label, stability data, and Certificate of Analysis to ensure label claims are met and the product is contaminant free. Additionally, the medical team evaluates the formula and dosage to evaluate if the formulation is safe and supports the product’s claims. 

Storage of dietary supplements at Fullscript’s distribution centers 

Fullscript’s distribution centers operate according to cGMP standards and maintain NSF/ANSI 455-2 certification for each facility. Careful considerations are made regarding proper supplement storage, transport, and delivery to ensure each product is maintained and handled according to the manufacturer's instructions. Proper storage is particularly important for dietary supplement products, as many require storage in specific temperatures to prevent ingredient degradation and spoilage.

Similar to manufacturer requirements, Fullscript’s distribution centers adhere to cGMP standards for the storage of supplements, including attentiveness to cleanliness, ensuring employee safety training, and having consistent operation processes in place.

All of Fullscript’s distribution centers adhere to safety codes and follow manufacturer standards for proper storage. Shelf-stable products are stored in a temperature-controlled environment. Heat-sensitive products, such as certain probiotics and omega-3 fatty acids, are stored in refrigerated environments. Temperatures are monitored 24/7, 365 days a year to guarantee that the products are continuously stored at their recommended temperatures.

Furthermore, all facilities are regularly inspected for sanitation standards, personal hygiene compliance, pest control, and equipment maintenance. 

Product recall process

Fullscript has a dedicated team responsible for overseeing product recalls and monitoring any quality concerns initiated by consumers and manufacturers. Although uncommon, supplement recalls can happen. Fullscript works closely with manufacturers and brands, allowing for a quick response in the event of a product recall. 

Once notified of a product recall, Fullscript quarantines all affected inventory at its distribution centers and directly notifies impacted customers. Providers whose patients have purchased recalled products are encouraged to advise them to contact Fullscript for a full refund. 

Communications to both providers and patients include clear instructions for returning or safely disposing of affected products.

Product complaint process

In the event of a quality concern or product complaint from a provider or patient, Fullscript maintains a rigorous quality consumer complaint procedure. When a consumer contacts Fullscript’s Customer Success team with a product complaint, all pertinent details are recorded, including lot numbers and expiration dates, and the complaint is reported internally, as well as to the specific brand. 

Complaints help the Quality Assurance team forecast possible voluntary recalls from brands, and they also allow Fullscript to continually evaluate the quality of the brands in the catalog. Depending on the nature of the complaint, Fullscript may request that the product be returned so that the brand can conduct necessary quality testing. 

Direct shipments to patients  

Once an order is placed, items are carefully packaged and shipped promptly to patients. Fragile products, such as supplements in glass bottles, are packaged with extra care to prevent damage while in transit.

Most heat sensitive-products are shipped inside an insulated pouch containing a reusable cold pack to keep them cool in transit. The fully frozen cold pack is placed into the insulated pouch when the order is prepared to ship, and as the cold pack thaws over the following days, the insulated pouch continues to keep the product cool. Heat sensitive products are designed to withstand short-term temperature variations, and remain safe and effective to use. If indicated on the product’s label, be sure to promptly place the product into the refrigerator for long-term storage.  

Did you know? Fullscript has five distribution centers, located in Arizona, California, Kansas, Virginia, British Columbia, and Ontario, Canada.

Fullscript Tested Program

As mentioned previously, Fullscript’s quality standards require that all distributed brands undergo an initial quality assessment, and incoming products are reviewed by the quality and medical teams. The Fullscript Tested program adds an additional layer of quality reassurance. Every quarter, up to 150 products are pulled directly from our distribution center shelves and sent to ISO 17025 accredited third-party labs for testing. These products are tested to ensure they are free of contaminants (heavy metals and microbials) and meet label claims. Products that have 100% of label claim and are contaminant free receive the Enhanced Tested badge. 

While all brands and products meet cGMP standards, the Fullscript Tested program systematically spot checks products to ensure these standards are met after distribution. Products that do not meet the strict Fullscript standards do not receive a badge. Products with  serious safety or potency results are removed from the catalog. 

The bottom line

At Fullscript, product safety and quality are a top priority. When introducing a new brand, the Fullscript Quality Assurance team carefully reviews the brand and their products, including standards, certifications, any associated complaints, compliance with FDA guidelines, and more. Fullscript stands apart from many retailers who do not specialize in supplements and, therefore, may not have the same measures in place to help ensure product quality and handle product recalls. Fullscript’s priority is to offer products that have been meticulously selected and monitored, stored, and shipped with care.