It’s a common misunderstanding that the Supplement business is an unregulated “Wild West”. This is not true, however, unfortunately, FDA is not devoting resources to monitor and ensure adherence to the existing regulations on the books for both supplements and drugs.
Generic drugs sold in US pharmacies are mostly made in India  (just ask any pharmacist) and have been found to not contain what is advertised on the label. However, news outlets refrain from talking about it because they don’t like to offend advertisers.
Unfortunately, both industries have plenty of manufacturers that don’t follow existing GMP regulations. The regulations are clear, but there is a lack of enforcement in both industries.
Supplements are regulated by FDA according to Good Manufacturing Practices under 21 CFR Part 111. This regulation was enacted by The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) of United States Federal legislation.
The Federal Food, Drug, and Cosmetic Act of 1938 (APA) is a federal law passed in 1938. The law established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States.
The brands that purchase from substandard contract manufacturers often promote their products as highly effective, and safe. Because of this, most of their customers don’t question the safety of the supplements and they equate fancy graphic design and claims of natural effectiveness with safety and security. They are oblivious to the fact that some supplements don’t contain what is advertised on the label and in some cases can even have harmful effects and negative impacts on their health.
The Secrets to a Successful Supplement Selling Business!
Aspiring supplement entrepreneurs’ first task should be to learn to distinguish good manufacturers from the bad ones in order to start their business off right. You will not be able to grow and expand your supplement selling business without the help of a reliable and trustworthy manufacturer. The increased number of contract manufacturing organizations (CMOs) at every corner of the market has definitely made it difficult to select a good manufacturer. A lot goes into building up a supplement selling business; therefore, making smart decisions is essential for business growth. Unfortunately, it’s difficult for a newcomer to evaluate and select a reliable supplement manufacturer because it’s not as simple as it seems. There are a number of important factors to take into consideration before selecting a supplement manufacturer for your business. Some of the important factors to keep in mind when selecting a supplement manufacturer are mentioned below.
The first impression remains irretrievable because it can do wonders in the truest sense. First, of course, you talk with your Sales Executive or Sales Manager, once you have worked with the sales group and want to go further it’s time to talk to some more people. Don’t stop your investigations into the CMO after chatting with the Sales Manager! After all, you are about to wire the CMO a good chunk of money and you want to make sure that you get excellent products before you pay down your deposit.
Even if you don’t visit with your potential CMO, ask to video chat with the Laboratory Director and the Quality Assurance Manager. Those should be two separate people and your Sales Manager should be happy to connect you. If those people aren’t located in the same company then this is a red flag – a sure indication that the supposed “CMO” is one of those companies that is simply a sales organization that doesn’t manufacture anything at all.
Once on the video chat ask them to show you the company GMP Flow Chart. They should present you with something akin to the below.
Image: General GMP Procedures for PureNSM
They should also be happy to screen share with you test results of raw materials and examples of in-process and finished goods testing reports. Then ask them to show you around the laboratory via a video call. Further, after signing an NDA they should be able to show you their most recent audit report from their GMP certifying organization such as NSF or UL.
Indeed, good quality supplements are the result of in-depth and exceptional manufacturing processes per GMP Master Production Records (MPR) and Standard Operating Procedures (SOP). From formulation to sourcing, testing, manufacturing, packaging, and branding, every step holds great importance when it comes to creating amazing supplements.
A very important question is to ask if the CMO has an in-house lab. If this is not the case you need to worry. An in-house lab is essential to any CMO worth their salt. Don’t fall for the claim that they outsource all their testing to a 3rd party lab. You need an in-house lab to move the project forward faster and keep a lower price point on the finished goods. Of course, every in-house lab will work closely with a 3rd party lab for specialty tests not possible to perform in-house. Ask them what laboratories they work with. Ask what equipment they operate in the lab and ask them to show you on the video to zoom in on the validation stickers on the equipment. Make sure they have analytical equipment named High-Performance Thin-Layer Chromatography (HPTLC). Without an HPTLC they will not be able to determine the identity of your herbal ingredients. This is a test that cannot be ignored and has to be performed 100% of the time before any herbal extracts or raw herbs are released from quarantine. Don’t let them get away with telling you that they have an HPLC which does the job, this is a lie. An HPLC is good for potency testing but not identity testing.
The Clean Label Movement
If you are going for the more refined “connoisseur” supplement buyer then ask the CMO if they have experience in creating supplements without the use of magnesium stearates and other excipients sometimes frowned upon by the more sophisticated consumers. This trend towards clean labels is long-standing and an extension of increased demand for organic pure foods and greater transparency in the manufacturing of foods and supplements.
[Candice, get a close up of a validation sticker on one of the lab equipments and paste it in here]
Process of Creating a Supplement Label:
Creating a GMP compliant supplement label is mandatory if you want to become a successful and diligent supplement seller. A non-compliant label is a sure attention-getter of FDA officers and a good reason for them to audit your brand. A good CMO will give you guidance in coming up with allowable claims that will not draw undue attention from FDA but will interest potential supplement buyers.
A supplement label should be as clear and detailed as possible because only transparent and in-depth information makes the label authentic and trustworthy. A good supplement manufacturer would give you detailed instructions on how to make your product label catchy, comprehensive, and most importantly compliant with current labeling guidelines.
Use of certified and verified ingredients:
A supplement will only have a therapeutic effect on the body if it is made with pure and high-quality ingredients that have passed identity, purity, and potency tests. A good supplement contract manufacturer systematically weeds out substandard ingredients in the formulation of supplements. Selecting a certified GMP compliant manufacturer is a great start, however not enough, you better also follow up as described above.
In many regards operating a supplement, the brand is about hedging your bets. A rainy day will arrive sooner or later when someone somewhere will put your brand, your product under the microscope. Keep this in mind when you select your supplement manufacturer. It’s not only FDA you need to worry about, but also FTC, Attorney General of California (Prop 65), Labdoor, and others you may need to reckon with.
You may think that since you are a young brand you can take some chances and select a contract manufacturer that offers super low prices and operates without regard for GMP. This has proven to be a deadly mistake for many, because even if no recall happens for years on end, if that particular supplement contract manufacturer runs afoul with FDA whole 7 years after you completed the last batch with them you can be in a world of trouble.
If the FDA knows you manufactured in a facility that is substandard, they may give your company name to major retailers such as Amazon, resulting in a sudden takedown, 7 years after you had your brand made by a substandard manufacturer. This just happened in late 2019 when 800 brands were recalled – all the brands one manufacturer made over a period of 7 years!
Select a reliable supplement contract manufacturer for your company. It reduces your risk tremendously! PureNSM is already behind many of the best selling supplement brands on Amazon. Make PureNSM your secret ingredient!
 Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban
Candice, where does this go?