At Fullscript, your health and safety are a top priority. Each brand and product offered in Fullscript’s catalog must meet strict quality, purity, label accuracy, 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 natural health products 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, quality standards, and dietary supplement quality assurance.
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 many supplements lack transparency regarding purity, quality, and safety.
If the production and distribution of a product does not adhere to strict manufacturing standards, often confirmed by a third-party certifier, the product may include expired ingredients, display inaccurate labels, and risk cross-contamination with other ingredients or microbiological contamination, among other critical issues that can 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 each product that is manufactured. (4)
Did you know? In the U.S., the FDA regulates dietary supplements under a set of regulations outlined by the Dietary Supplement Health and Education Act of 1994 (DSHEA). (11)
Good Manufacturing Practices (GMPs)
Good Manufacturing Practices are standards implemented by the FDA and developed with the intent to protect consumers and allow all 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) These standards allow distributors, like Fullscript, to be held accountable for consumer safety and ensure their products meet quality standards.
Good Manufacturing Practice (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)
Established by the FDA, cGMPs exist to verify that supplements are produced consistently and meet specific quality and safety standards. (11) To be cGMP-certified, manufacturers must adhere to the following standards:
- Places – locations where products are manufactured and stored are sanitary
- People – employees are trained on proper cleanliness and safety processes
- Processes – consistent operations are in place to provide authenticity and safety
- Products – products are checked throughout manufacturing, storage, and delivery for authenticity, safety, and accuracy
Adding new brands at Fullscript
To ensure the catalog provides the highest quality products to practitioners 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 ensures 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 questionnaire that requires the disclosure of the following information from brands:
- Accurate label claims
- cGMP auditing & certifications
- Compliance reporting
- Description of internal quality teams
- FDA inspections
- Finished goods quality testing practices
- Internal training programs on quality maintenance
- Label and facility testing
- Manufacturing personal information (both internal and external)
- Quality assurance policies and processes
- Raw ingredient information
- Recall procedures
- Testing for adulterants and contaminants (e.g., heavy metals, chemical substances, pesticides)
Fullscript’s Quality Assurance team then assesses the information collected from the quality control assessment to ensure that the brand’s products are produced with consideration for quality, purity, transparency, and safety.
In collaboration with Fullscript’s Integrative Medical Advisory Team (IMAT), the Quality Assurance team has recently 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 strongly encourages current brands to register with third-party certification programs 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 certifications include the following:
- cGMP (12)
- International Organization for Standardization (ISO) 9001 (3)
- NSF International (6)
- Non-GMO Project (8)
- Natural Products Association (NPA) (5)
- SGS (General Society of Surveillance) (7)
- Underwriter Laboratories (UL) (9)
- USDA Organic (10)
Did you know? Each month, Fullscript receives 49 new brand requests on average, but only adds approximately one to two new brands to the catalog to ensure only the highest quality brands are included in the catalog.
Storage of dietary supplements at Fullscript’s distribution centers
Fullscript’s distribution centers operate according to cGMP standards and in compliance with the NSF International guidelines. 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 maintained at a temperature of 68 to 77 degrees Fahrenheit (18 to 25 degrees Celsius). Heat-sensitive products, such as certain probiotics and omega-3 fatty acids, are stored in refrigerated environments at 36 to 46 degrees Fahrenheit (2 to 7 degrees Celsius), with humidity at no more than 60%. 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 alerted of a product recall, Fullscript quarantines existing products in affected distribution centers and notifies practitioners directly. Practitioners of patients who have purchased recalled products are urged to advise their patients immediately. Provided in the communications to practitioners are clear instructions for handling the return or disposal of affected products.
Product complaint process
In the event of a quality concern or product complaint from a practitioner 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.
Any 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 are completely 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 three distribution centers, located in Phoenix, Arizona, Lancaster, Pennsylvania, and Mississauga, Ontario.
Emerson Quality Program (EQP)
Fullscript and Emerson Ecologics are now coming together as one team. But what does that mean for quality? We’re excited to announce that providers and patients can now look forward to new quality content including the Emerson Quality Program on the Fullscript platform! For those that are new to the Emerson Quality Program, a brief summary of the program and its key components are below.
As mentioned previously, Fullscript’s quality standards require that all distributed brands undergo an initial quality assessment. Through the Emerson Quality Program (EQP), an established industry standard in providing quality assurances, Fullscript invites brands to be transparent about their confidential manufacturing processes so that Fullscript’s Integrative Medical and Quality Assurance teams can carefully and comprehensively evaluate them. Depending on their manufacturing standards and quality practices, brands may qualify as an EQP Gold-level partner or as an EQP Silver-level partner.
EQP Gold and Silver level partners are held to a higher standard that includes:
- Testing: Quarterly testing by Fullscript and independent third party labs in regards to contamination, identification, or potency of finished supplement products. We may also compare the testing results of our brands to other non-professional or consumer brands to understand the differences in quality.
- Inspections: Virtual or Onsite audits of manufacturing processes, thorough product label claim reviews, and expiration date verification at regular intervals by Fullscript quality experts.
- Manufacturing Procedural Evaluation: A thorough audit of all manufacturing standards and processes
- Sourcing/Sustainability: Understanding the quality, origin, and sustainability of the raw materials used to manufacture dietary supplements. This includes comprehensive testing requirements for materials.
Through extensive document assessments, on-site audits, and independent finished product testing, the EQP helps ensure that everything is in place for EQP partner brands to offer the highest quality product available for practitioners and their patients.
By selecting products in the distribution centers, and testing these products on a quarterly basis with independent qualified laboratories, the EQP continually confirms the high quality standards expected from these brands.
Other third party distributors may claim that they have the best quality programs, but don’t be fooled by imitations. Fullscript and Emerson are the market leaders in quality supplements. Only Fullscript and Emerson Ecologics have the longstanding expertise and commitment to the standards set by the EQP.
“Let Fullscript and Emerson Ecologics focus on supplement quality so you can focus on your patients.”
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 all products, including their standards, certifications, any associated complaints, claims, 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 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.
- Health Canada. (2020). Natural and non-prescription health products directorate. https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/natural-non-prescription-health-products-directorate.html
- International Society for Pharmaceutical Engineering. (n.d.). What is GMP? https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
- ISO. (2020, June 11). ISO 9000 family — Quality management. https://www.iso.org/iso-9001-quality-management.html
- National Institutes of Health. (2020). Dietary supplements: What you need to know. https://ods.od.nih.gov/factsheets/WYNTK-Consumer/
- Natural Products Association. (n.d.). Natural Products Association. https://www.npanational.org/
- NSF. (2021, February 24). Food consulting solutions. NSF International. https://www.nsf.org/consulting/food
- SGS. (n.d.). SGS. https://www.sgsgroup.us.com/
- The Non-GMO Project. (n.d.). What is a GMO? – the Non-GMO Project. Non-GMO Project. https://www.nongmoproject.org/gmo-facts/what-is-gmo/
- UL. (n.d.). UL Empowering Trust. https://www.ul.com/
- U.S. Department of Agriculture. (n.d.). USDA Organic. https://www.usda.gov/topics/organic
- U.S. FDA. (2007, June 25). Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. https://www.federalregister.gov/documents/2007/06/25/07-3039/current-good-manufacturing-practice-in-manufacturing-packaging-labeling-or-holding-operations-for
- U.S. FDA. (2020, September 21). Current good manufacturing practice (CGMP) regulations. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations