Oct 17, 2018 11:17:23 AM
Written By:
Dom Orlandi, President of DaVinci
“I would never ask patients to put something in their body that I wouldn’t take myself.”
One of our customers, a practicing physician, said that to me once, and it struck me what an incredible responsibility we both share.
Patients trust their practitioners to make good recommendations for their health, and practitioners, in turn, depend on us to provide the highest quality supplements on the market.
But how many people really know how to determine a quality product from one best left on the shelf?
Even when a product meets federal standards for truth in labeling, it may not be the best one out there. To successfully compare supplements and find the ones with the highest quality, you’ll need to know what the standards are and what to look for in a product that meets or exceeds those standards.
This post outlines how federal regulations guide companies to create quality supplements, and tells you what you can do to ensure you’re giving your patients top notch ingredients that have been properly tested, formulated, and produced.
The first priority with any supplement is knowing that it is safe for patients.
The Fair Packaging and Labeling Act, passed into law in 1967, remains the driving federal force that requires commodities intended for human consumption be labeled with the product’s net contents, the identity of the commodity, and the name and address of the business distributing the product.
Meeting that label claim is important, and to do so supplements should always contain active ingredients and standardized extract amounts.
Maintaining formulaic integrity isn’t as easy as you’d think, though. For some formulas, overages of certain ingredients must be factored in to account for a degradation curve. Some ingredients, such as folic acid, are volatile and won’t stay stable for as long as other ingredients.
For folic acid, roughly 15% overage is added to maintain potency for the length of the expiration date. This is why you’ll see products marked with a shelf life of maybe two to three years.
The Food Drug and Cosmetic Act, which can be located in the Code of Federal Regulations Title 21 Section 111(CFR-21-111) provides a number of guidelines, provisions, laboratory production controls, and distribution guidelines for supplements.
Current Good Manufacturing Practices (CGMPs), as required under this act, ensure testing is done on every raw material for a supplement. These tests measure purity, potency, identity, and contaminants in order to prove the product meets all standards put in place. CGMPs also provide a statistically valid method for substantiating label claim on the finished product.
Third-party companies like Consumer Labs randomly test supplements and posts the results. Not all supplement providers are doing their due diligence, and a third-party verifier helps weed out the less than honest ones.
But because different combinations of ingredients result in different reactions in people over time, formulas that ensure a label claim can be met at the beginning as well as the end of a shelf life is key.
This long trail of traceability doesn’t have to be documented publicly, but it does have to be documented.
If the FDA audits a supplement provider, they need to be able to deliver proof of process material, master manufacturing records, protocols, and Standard Operating Procedures (SOPs). The FDA will ask to see that proof, and they’ll ask to see it immediately so the documentation must be readily available, even if the company outsources the manufacturing.
Supplement manufacturers should be well versed in testing.
It’s not something you just call and order up. Providers need to know which tests determine the right standards and can validate the ingredients. The provider who orders the testing will dictate the test practices and the onus is on them to figure out which ones to ask for because standards can change over time.
In addition to tests on raw materials for purity, potency, identity, and contaminants, supplement manufacturers may test for:
Providers should not use "free of" statements such as “gluten-free” or “soy-free” on a label unless it’s been tested.
When raw materials come in, they’re quarantined immediately. They can’t enter any part of the facility where there’s potential for cross-contamination.
Some of the testing can be done in-house once the materials are on QC hold. They can also be sent out to a third-party for testing, which will take a bit longer. Testing isn’t a one-day process. To test for contaminants like mold and yeast, microbials must be grown. Once the ingredients are tested and shown to meet the specifications on the certificate of analysis, the raw material can be released from QC hold.
The manufacturing process comes with its own set of checkpoints that verify proper blending of ingredients, encapsulation, and bottling.
An internal quality control process will pull any supplements that didn’t fill up all the way, cracked in production, or were damaged somehow. Once all of these standards are met, the product can be sent out for label claim testing.
Label claim testing can be done in-house if the provider has the appropriate equipment, but usually this testing is done by a third party lab, such as Eurofins, Silaker, or Covance.
Audits that check for CGMP compliance and supplement safety occur randomly. These checks are done by a third-party organization to make sure production processes and facilities are compliant with federal standards. If anything is found to be non-compliant, typically a company will be given 30 days to comply.
As a functional medicine practitioner, you want to be able to trust every supplement bottle you pick up. But it’s not that simple. Here’s how you can quickly verify a product’s quality:
When it comes to supplements, quality is the highest priority for every functional medicine practitioner. And it should be. People are trusting you to help them feel and live better, and that’s nothing to take lightly. By staying informed of federal guidelines, doing a little research on providers, and knowing what to look for on the label, you can ensure you are offering only the best to your patients.
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