FDA Qualified GMPs & TruLabel Supplements
All our supplements are made in the USA and in GMP / TruLabel labs for assurance of top quality products. This article gives some information about quality testing standards. It includes excerpts from Kevin M Connolly, PhD.
Taking Supplementation Seriously
Until recently, the only way to assess the quality of a supplement (short of spending a personal fortune on lab testing), was subjective data such as brand reputation, marketing claims, and personal experience.
The recent definition of the Good Manufacturing Practices (GMPs) for dietary supplement manufacturers by the Food and Drug Administration has significantly improved how supplement quality is viewed. The 1995 Dietary Supplement Health and Education Act (DSHEA), in addition to legally defining supplements and setting guidelines for their sale and marketing, also provided for a set of regulations governing their proper manufacture. It wasn’t until 2007, however, that these rules (the GMPs), were finally issued by the FDA.
The GMPs are a set of requirements and expectations for the quality manufacturing, testing, and storage of dietary supplement products. They were phased in over a three year period; as of June 2010, all manufacturers are expected to be GMP-compliant. GMPs are a great benefit to consumers, and promise to dramatically improve confidence in their dietary supplement choices.
While generally viewed as a positive step, the implementation of the FDA GMPs is relatively new, and the regulations themselves still contain areas (such as testing requirements) that are not fully defined. It may also be some time before the FDA gets around to assessing the GMP compliance of every dietary supplement manufacturer, if they even choose to do so. Therefore it is useful to be familiar with other resources to determine the quality of a supplement product; this article outlines some of the most common.
What is Quality in a Dietary Supplement?
There are several ways to define quality for a supplement, but conventional assessments of supplement quality usually concentrate on two areas:
1. Adherence to label claims. It is fairly obvious that a quality supplement should contain the amounts of each ingredient (within an acceptable margin of error) stated in the Supplement Facts panel.
2. Freedom from adulteration. Although adulteration suggests some sort of malicious intentional contamination, in terms of GMP, it is officially used to describe any contamination of a dietary supplement product. This includes:
- Elevated levels of toxic metals (lead, mercury, cadmium, arsenic, etc.),
- High levels of microbes,
- Toxins, natural or man-made (pesticides, herbicides, chemical wastes).
Ingredient quality and manufacturing quality can be treated as separate measures that must both be considered when choosing a quality supplement. A good manufacturer cannot make a quality supplement using poor quality ingredients, just as the best ingredient cannot add to the quality of a product if the manufacturer cannot reliably put the correct amount in the bottle.
Identifying Quality in a Supplement
Third party product testing, directly demonstrate that the product adheres to label claims and represent the best affirmation of product quality. Unfortunately, only a fraction of the supplement market will ever get an independent test, so the savvy consumer must often look for other quality indicators when making a quality assessment.
Standardization: An indirect measurement of ingredient quality, standardized ingredients contains a measurable amount of a particular compound. This is most often applied to extracts. For example, milk thistle contains hundreds of different compounds; the most active for liver detoxification is the compound silymarin. Therefore, to guarantee the desired activity of milk thistle, manufacturers extract and process the seeds of the milk thistle in a way that preserves a consistent, measurable amount of silymarin (as in “Milk thistle, standardized to 68 percent silymarin”). However, not all herbs and nutrients are, or can be, standardized.
Branded ingredients: These refer to manufacturers who have a “specialized” manufacturing techniques or animal or human clinical trials. While not a direct quality measurement, branded ingredients are usually better tested.
Pharmacopoeiae: These are standards (monographs) developed and maintained by independent organizations of scientists as recommended guidelines for manufacturing quality. The most familiar in the U.S. is the United States Pharmacopoeia (USP). These are not independently verified but assumed to be a higher and labeled (ex: glutamine USP).
The USP also maintains the USP Verified Dietary Supplement Ingredient Program, a voluntary program in which manufacturers can have individual ingredients verified for manufacturing consistency, meeting label claims for purity, potency, and quality, and acceptable limits of contamination. The USP website maintains a list of ingredients and manufacturers which have been verified under this program.
The Best Indicators
1. GMP Manufacturing Certification: This is FDA regulated Good Manufacturing Practice. All dietary supplement manufacturers and distributors are required to adhere to the FDA GMPs. However, most have not been audited by the FDA, so their compliance is not necessarily guaranteed. Therefore, there are organizations that perform independent audits to certify compliance.
cGMP: The set of current, up-to-date methodologies, practices, and procedures mandated by the Food and Drug Administration (FDA) and the Internal Conference on Harmonization (ICH) which are to be followed in the testing and manufacture of pharmaceuticals. The set of rules and regulations promulgated and enforced by the FDA and other countries’ regulatory authorities to ensure the manufacture of safe clinical supplies. All Novasep API and biopharmaceutical manufacturing facilities operate under current Good Manufacturing Practices (cGMP).
2. Third Party Testing: This is also strong evident of individual product quality. However, very few companies do this because it adds considerable cost to the products, usually not practical – especially if it is a GMP certified manufacturer.
The USP Dietary Supplement Verification Program, the TruLabel program and ConsumerLab tests supplements. Products which pass testing bear their seals.
The TruLabel Program is a dietary supplement label registration and random-testing program. This internal oversight program was designed to create a high level of confidence with retailers and consumers that products sold in the marketplace are accurately labeled.
The TruLabel program provided database information to defend the industry when elected officials and regulatory agencies have questions and/ or make incorrect statements about products. The random testing has been beneficial to the industry also as the test results have been used to backup concerns about products or ingredients in the marketplace.
QUALITY ASSURANCE
Cedar Bear Naturales™ QA/QC (Quality Assurance / Quality Control) Standards
Cedar Bear Naturales™ and its departments all adhere to the same exacting and stringent QA/QC standards. These standards serve three purposes. 1st is to assure that safe and accurate ingredients are used in all products we produce. 2nd is to make sure that the controls are in place for clean contaminant-free production that meets the highest standards for our industry. and 3rd is to assure that the finished products are verified as being safe for human and animal consumption. The following QA/QC standards are utilized and adhered to by Cedar Bear and its departments:
U.S. FDA cGMP Inspected
cGMP stands for current Good Manufacturing Practices. The cGMP standard that all companies in the dietary supplements industry (which herbal manufacturers are part of) must comply with is the U.S. Federal Government's FDA cGMP rules & regulation policy. Though different than FDA cGMP standards for the drugs & pharmaceutical industry, the FDA cGMP standards for herbal & dietary supplements industry are very detailed and stringent, and in some areas are more restrictive and stringent than that for drug & pharmaceutical industry cGMP rules & regulations.
Cedar Bear FDA cGMP standards are guided by 21 CFR 111 and 21 CFR 110 policy & rules. 111 deals with all aspects of the 'intrinsic' product itself, while 110 deals with product labeling and claims issues. Both are part of FDA cGMP oversight of the herbal & dietary supplements industry for product quality & safety and accuracy of product labeling & claims.
Cedar Bear Naturales™ is FDA cGMP inspected on an ongoing basis.
Kosher (Kashrus) Certified
'Kosher' is a very stringent consumables preparation standard rooted in antiquity and proven in modern food and dietary science. Where the word 'kashrus' is used, it means to be in a state of being kosher, which all Cedar Bear Naturales® retail brands are.
Our kosher certification is done through Scroll K, an OU (Orthodox Union) recognized affiliate kosher certifying agency. Some aspects of the kosher certified standard we adhere to are actually more stringent than FDA cGMP standards for the same aspects.
Statistics have shown that over 70% of individual shoppers seeking kosher certified prepared products are not of the religious affiliation from which kosher originated. Their reason for seeking out kosher certified products is the assurance such products are manufactured to consistently clean standards and don't contain ingredients deemed to be harmful to health and well-being in general.
Vegan Certified
Cedar Bear uses no animal parts or ingredients in its products. Even the glycerin used is 100% USP Grade GMO-Free Kosher Certified 'Vegetable' glycerin.
Gluten Free
Since no grain alcohol is used in the making of Cedar Bear TincTract® products there is no chance of contaminating our products with alcohol that may in some instances contain gluten tags, which in very gluten sensitive individuals can set off adverse gluten caused reactions. And yes, if the fermented grains from which alcohol is distilled is not double, or better yet, triple distilled, there is no guarantee that light mole weight gluten particles will not distill into the alcohol during initial distillation for alcohol.
Also, no Cedar Bear retail brands products contain gluten-containing ingredients. Only herbs, glycerin, and water are used in the making of our products utilizing the revolutionary and proprietary 'Genuine TincTract® Made' process for making our concentrated and potent liquid herbal products.
Totally Additive Free
All Cedar Bear Naturales™ retail brands liquid herbal products have no additives, chemical preservatives or added flavoring agents. Amazingly, our products taste great, possess amazing shelf life stability, and, they require no refrigeration, even after opening!
FDA 'Full Disclosure' Product Label Compliant
Unlike many competitor herbal product companies who qualify to take the FDA labeling rule exemptions on full disclosure, and have done so, we here at Cedar Bear Naturales™ chose to not take those exemptions but instead chose to provide consumers with product labels that are full disclosure as detailed in FDA rules & regulations on the issue.
Full disclosure labeling is one way we prove to consumers that we are more interested in their getting ALL the information FDA labeling standards are intended to provide for concerned consumers, even if it costs us more to do so.
Supplement Quality Assurance: cGMP, Processes, and More
July 4th, 2019
Written by Diana Kolesarova
Supplement Quality Assurance: cGMP, Processes
As a practitioner, quality is the most important factor to consider when looking for a trusted source to provide health products for patient wellness. An abundance of policies and processes can make it difLicult to Lind exactly what you’re looking for and may defer time away from patient care in order to understand quality assurance. You may also be faced with multiple solutions and may not know which to choose.
At Fullscript we make it easy to access the information you need about the quality of our products by maintaining transparency with our users and by following national & international regulations and policies.
Maintaining high standards in warehouses, where supplements are stored before being delivered to patients, is important for all Fullscript facilities.
The importance of quality is equally relevant all the way from the product’s production to consumption. Throughout the lifecycle of a supplement, care and quality assurance is necessary to ensure that the end consumer – your patient – is getting what they need to optimize their health.
Our quality assurance team knows what to look for when taking care of more than 15,000 products, partnering with over 300 suppliers, and keeping products at their individual standards in our warehouses.
Why is quality important for supplements?
Quality control for supplements is crucial as they help keep people healthy! If supplements are not manufactured and resold under quality supervision, they can end up with expired ingredients, cross-contamination, improper labels, and other severe issues that can risk consumers’ health.
Dietary supplements and wellness products are approached differently than pharmaceuticals. In the United States, the Food and Drug Administration (FDA) oversees the regulations and practices for supplements and natural wellness products. The importance of assessing products helps establish
Good Manufacturing Practices (GMPs). The standards look at the identity, purity, strength, and composition of each product that is manufactured. (1) In Canada, Natural Health Products (NHPs) are regulated by Health Canada under the Natural and Non-prescription Health Products Directorate (NNHPD). (2)
Good Manufacturing Practices (GMPs)
These standards are meant to allow all manufacturers and resellers of supplements to avoid unsafe and incorrect ingredients in products. The GMP standards also ensure that the possibility of contamination and the improper packaging and labeling of a product is avoided. (1)
The standard allows resellers, like Fullscript, to stay accountable for overall health and safety.
Current Good Manufacturing Practice (cGMP)
Good Manufacturing Practice (GMP) is also sometimes referred to as cGMP, where the ‘c’ stands for ‘current’. (3) The Current Good Manufacturing Practice (cGMP) reminds supplement manufacturers and resellers to stay up to date with their processes, equipment, technologies, and policies in manufacturing and reselling supplements. (3) The FDA developed cGMPs to ensure supplements are produced in a consistent manner and meet quality and safety standards. (4)
How does Fullscript ensure quality?
To ensure our catalog provides the best quality options to practitioners, we’ve partnered with the best professional-grade supplement brands who follow cGMP standards. You can know that everything you search for on Fullscript is manufactured to improve patient care, taking the worry off of you, and saving you time in deciding what to recommend.
Trust in knowing the products you recommend to your patients are from vetted manufacturers, have been stored in compliant warehouses, and will be delivered with the utmost care.
To become a partner and supplier on Fullscript, all vendors must go through an in-depth questionnaire and provide quality information. I always receive the best service from Fullscript. It is easy to connect to the platform, purchase and receive products. I am very comfortable knowing that the products I recommend are top of the line. -Doreen T., RN
Onboarding of brands
Maintaining the largest catalog in the industry takes an entire internal team to ensure
processes and policies are followed so brands can join our catalog. The Fullscript
onboarding process for brands is in-depth and consists of a quality control questionnaire.
This document qualifies information about Brands on the following points:
- Quality assurance policies and processes
- Internal training programs on quality maintenance
- Description of internal quality teams
- cGMP auditing & certifications
- Manufacturing personal information (both internal and external)
- FDA inspections
- Label, and facility testing
- Finished goods quality testing practices
- Raw ingredient information
- Compliance reporting
- Recall procedures
Did you know?
On average Fullscript onboards 5 new brands to the catalog on a monthly basis.
With quality processes, the brands being added to the catalog are the best for
patient care.
The more we know about brands and products, the better service we can offer to practitioners. With information, we’re able to improve features like advanced search so you can Lind products based on allergens, formulations, ingredients, and more! Our quality assurance also allows us to pass along information such as therapeutic value.
Fullscript encourages brands to undergo 3rd party certiLication programs, to ensure and further validate product quality. Amongst others, certifications include:
If a supplement manufacturer meets GMP standards, they will have the cGMP designation. You can be conLident that the products we carry are authentic, have been monitored to guarantee no contamination, and have been manufactured consistently and safely.Storage of supplements
At Fullscript, we operate by cGMP standards, including our distribution centers’ policies and processes. As a company, we’re compliant to the National Sanitation Foundation (NSF) guidelines. (10) Everything from the storage of supplements, to transport and delivery, is all carefully monitored and controlled.
To be labeled cGMP certiLied, we also follow the 4 categories of good manufacturing practices:
- Places – ensures that the location where products are stored is clean
- People – ensures that employees are trained on proper cleanliness and safety processes
- Processes – ensures that there are consistent operations to provide authenticity and safety
- Products – ensures that products are checked throughout manufacturing, storage, and delivery for authenticity, safety, and accuracy
Places
Our facilities follow safety codes and are up to manufacturer standards. Products are stored in 68-77 degrees Fahrenheit and 36-46 cold storage, with humidity at no more than 60 percent. These measures ensure heat sensitive products are separate from those that do not require temperature attentiveness. Within our facilities, temperatures are monitored and logged 24/7, 365 days a year. Our facilities are totally secure and visitors are logged for safety purposes.
Preventative maintenance and calibrations for critical storage components include:
- HVAC
- Cold storage
- Weight and measures equipment
People
When storing supplements in our warehouses, we ensure our employees go through a training program to successfully handle all products, including temperature-sensitive products such as probiotics. Fullscript employees learn about supplementation, ingredients, and have the confidence to identify and handle different ingredients.
Our quality processes are followed by team members inside and outside of our distribution facilities.
Processes
Our processes for storing products are followed by every team member at Fullscript, both inside and outside our facilities.
Product recall process
In rare circumstances, product recalls may occur. We make sure to assist in the recall process by alerting our practitioners in these cases and can provide guidance in dealing with product returns or disposal. The obligation is on us, and we have a rigorous recall process, including a dedicated team that oversees recalls that affect the catalog and monitors the process from manufacturer to the end user.
Whether the recall is voluntarily initiated by the brand or is mandated by the FDA, we have three touch points, with both the healthcare practitioner and patients, via email and regular mail to ensure that procedures are in place to assist in the recall process. Unfortunately, many supplement resellers do not establish recall procedures which may expose you and your patients to health and safety risks. Our strict policies and processes for product recalls can give you conLidence that your patients’ health and safety is at the center of our attention.
Product complaint process
You can also rest assured that we have a quality consumer complaint procedure. We record everything the compliant entails and make a point to report it internally as well as to the brand in question. Complaints help us forecast possible voluntary recalls and they also help us constantly evaluate the quality of the brands we work with. Our customers are always heard.
Products
Products that are stored in our facilities are cared for from the moment they get to the warehouse to the moment they get to a patient’s home. We keep a log of all products through lot tracking. We can be conLident in having an overview of all products in the warehouse at any time. This is important for instances where recalls happen. Focusing on temperature standards also allows us to make sure heat-sensitive products are cared for appropriately and maintain their potency.
Wonderful products, prompt service and delivery. My Physician recommended that I purchase my supplements from Fullscript because of the purity of their products. -Frankie J., Patient
Direct shipments to patients
Once supplements are recommended and ready to be shipped to patients, we package them with care and make sure they are stored properly. Heat sensitive products are shipped with a cold pack to keep them cool. Although short-term heat exposure may not affect the potency of heat-sensitive products, we follow standards to control and monitor the temperature of the product even after it has left the warehouse.
Each product is packaged and tracked with care. We deliver quality supplements to the patient.
The bottom line
When it comes to quality, there are no shortcuts. At Fullscript, we understand that the focus on quality starts from selecting the right brands to include in our catalog, and does not end until the recommended product has been delivered to the patient.
Supplement resellers who do not specialize in supplements may not establish quality control assurances. They may not have processes in place for recalls and complaints, and they may not utilize warehouse optimization strategies and training programs for staff.
Potential new brands are always reviewed by our team to ensure quality. The Fullscript Quality Assurance Team reviews all products, including their standards, certiLications, any associated complaints, unsubstantiated claims, compliance with FDA guidelines, and more.
Tips for practitioners: always look for certiLications – if Current Good Manufacturing
Practices are not met, the quality of products may be in question. Choose the right resellers
to partner with so that you can optimize patient care.
Dietary Supplement Testing and Analysis: Quality Control
by NaturPro in Uncategorized
Dietary Supplement Testing and Analysis: Quality Control
Dietary supplements are subject to FDA requirements for good manufacturing practices (cGMP) and quality control in the United States. cGMP require specifications for each ingredient and finished dietary supplement. The specifications list parameters for identity, purity, potency and other requirements for regulatory compliance. Each parameter on the specification must be tested with a scientifically valid method.
NaturPro Scientific, as an UnLab, partners with expert analytical laboratories to conduct specific testing on dietary supplements. Testing typically includes:
- Physical characteristics (visual, color, odor, taste, density, mesh size)
- Identity (matching an ingredient in a pass/fail fashion to a particular species of botanical or herb, or a chemical purity test)
- Potency (concentration of active or marker compounds)
- Purity (absence of impurities such as moisture, microbiology, pathogens, heavy metals, residual solvents, pesticides, mycotoxins)
- Karl Fischer
- Ro-tap and particle size analysis
- Titration
- Gravimetry
- Thin Layer Chromatography (TLC or HP-TLC)
- High Performance Liquid Chromatography (HPLC)
- Gas Chromatography with Flame Ionization Detection (GC-FID)
- Gas Chromatography with Mass Spectrometry (GC-MS of GC-MS-MS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Total Aerobic Plate Count
- Pathogens (Salmonella, E. Coli, Staph)
- Documentation of the specifications established (21 CFR 111.95(b)(1))
- Documentation of your qualification of a supplier for the purpose of relying on the supplier’s certificate of analysis (21 CFR 111.95(b)(2))
- Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement (21 CFR 111.95(b)(3))
- Documentation for why the results of appropriate tests or examinations for the product specifications that you selected for testing ensure that the dietary supplement meets all product specifications (21 CFR 111.95(b)(4))
- Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under 21 CFR 111.75(d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under 21 CFR 111.75 (c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage (21 CFR 111.95(b)(5))
- Dietary Supplement Ingredient Database, https:// dietarysupplementdatabase.usda.nih.gov/
- Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/ DietarySupplements-HealthProfessional/
- Dietary supplement laboratory quality assurance program: the first five exercises. Phillips MM, Rimmer CA, Wood LJ, Lippa KA, Sharpless KE, Duewer DL, Sander LC, Betz JM. J AOAC Int 2011;94:803-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173719/
- Heavy metals: analysis and limits in herbal dietary supplements, http:// www.naturalhealthresearch.org/wp-content/uploads/ 2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf
- Pesticide Analytical Manual, Vol I, FDA. Source: http://www.fda.gov/downloads/Food/ FoodScienceResearch/ucm113702.pdf
- Pesticide Analytical Manual, Vol II, FDA. Source: http://www.fda.gov/downloads/ Food/FoodScienceResearch/ucm113721.pdf
- Quality assurance of cultivated and gathered medicinal plants. Mathe and Mathe, Source: http://www.mtk.nyme.hu/fileadmin/user_upload/kornyezet/Mathe/Quality_assurance.pdf
- Quality control methods for medicinal plant materials (1998) World Health Organization
- Recommendations for microbial limits in herbal products, American Herbal Products Association, http://www.ahpa.org/Portals/0/PDFs/Policies/ 14_0206_AHPA_micro_limits_comparisons.pdf
- Standardization of herbal medicines – A review. Kunle O.F. et al, (2012) Int. J Biodiv and Conserv. 4(3) 101-112. Source: http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf
- USP Food Fraud Mitigation Guidance, http://www.usp.org/food/food-fraud-mitigation-guidance