If you don’t ask those questions you are risking that your products don’t meet label claims or worse… causing harm to your customers, getting sued and spending time in prison.
If you’re a marketer of nutritional supplements, the most important single question to ask yourself is “What product should I put on the market?” But once that’s been answered, the second most important question is, “Who should manufacture that product?” The right choice can make the difference between a market leader or an average product, between an easy process or a painful one, between success and failure.
Before you ask a single question…
Save yourself some time, before you even pick up the phone or email a contract manufacturer make sure they DO NOT display (1) any unauthorized trademarks from FDA or USDA (2) any made-up GMP icons.
WARNING: If a contract manufacturer displays either the FDA logo or the above USDA trademarked logos, they are doing so WITHOUT a permission and are breaking multiple regulations and laws, including trademark laws.
Those companies are misleading and knowingly deceitful. Such behaviors can trick naïve people to do business with such entities and in turn receive DANGEROUS products that may end up killing someone. This kind of behavior must be reported as a matter of safety violation.
It is clearly a matter of your civic duty to report such unauthorized use of FDA and USDA trademarks to the authorities without delay.
Report safety violations to FDA here:
Report safety violations to USDA here:
The above icons carry not guarantees of any compliance with GMP protocols!!!! You can have one of those designed for $5 or pick them up for free on the internet and display them on your website. We found 100s of those icons on Google.
It is extremely dangerous to do business with anyone who uses one of those icons. Making supplements is a serious concern. You may not realize it at first and think that this industry isn’t regulated. Indeed, it is heavily regulated, and for a reason. A good reason that is.
It’s a fact that FDA most frequent Warning Letters, called “Form 483” are about failure to perform finished good testing. Why do you think they focus on that? Perhaps because its a fact that if oil soluble vitamins are not correctly manufactured that they can cause people to go on kidney dialysis for life and can kill people in the worst case. Further it is a fact that the factory is the last line of defense against bacterial infections in supplements. Food is for the most part either washed or boiled, a process that gets rid of bacteria’s, but with supplements it’s a different story. When is the last time you rinsed off a capsule in the sink before you swallowed it? It is therefore very important that the facility follow basic GMP protocols when manufacturing and testing the quality of supplements.
Do not go with a manufacturer that displays any made-up logos concerning GMP Certifications. They are lying to you! Why do business with liars? Why pay them thousands of dollars? Will they be in business when you think you can pick the product up? We have heard multiple stories about people losing their deposits to companies that display such logos. Further, once they have your money their customer service skills go down the toilet.
The only companies you should be calling are companies that can be verified to be certified GMP compliant. If you for example see an NSF certification for GMP then you to go this website:
You type in the company name in the search field and then you should find the company easily, including the company logo. For PureNSM you would search using our full company name:
Nutritional Supplement Manufacturers
Then you should get this page for the company you searched for.
Do what Amazon does periodically with all their products they carry. They check out if the facility manufacturing the product is certified. Again for NSF certifications you go to this website:info.nsf.org/Certified/GMP (no www.) in order to verify. To check our company out, you enter our name: Nutritional Supplement Manufacturers
For UL certifications for GMP compliance you go to the UL website:
Then you click Ctrl+F and search for PureNSM or Nutritional Supplement Manufacturers.
If you don’t do the above you may be in for a surprise when you try to get your product approved on Amazon. They require a GMP Certification and they know how to verify them! Here is how they do it…
When you apply to have your products carried on Amazon you point out that you have verified your contract manufacturer. This earns you extra credit with your (unknown) Amazon Mistery Rep!!!!
This will speed things up for you! But first…
But first you must have an invoice generated by us. You then give the invoice number to Amazon. Someone from Amazon then calls us and checks out our certifications periodically in addition to checking out if we are still manufacturing for you.
They do that by calling us (yes, we talk to Amazon many times!!!) and asking us for the lot numbers on your product.
The answers to these questions should make decision-making easier and yield the best conclusion. No one good answer will be a dealmaker, but most good answers will give you a significant advantage.
We suggest you ask them the following questions
1.Do you own and operate an HPTLC and do you test 100% of my botanical raw materials on it, and can I get a picture of the results, that show’s that my batch has been tested?
How do you make sure you aren’t unintentionally scamming your clients? Do you really know what’s in your product?
If the factory you are hiring does not own and operate an HPTLC system (from CaMag or another comparable brand)and tests 100% of all incoming botanicals, then you may have over 30% chance of not meeting label claims. Are you sure you want that liability, karma, reputation? You put a lot of effort into building a good brand, why not go all the way and ensure your product is up to snuff?
We reject 10% of all raw herbs and all extracts because the materials fail the HPTLC identification tests. We test 100% of all the botanical raw materials for identity using the HPTLC. This is after operating the system for many years and collecting over 250 standards. When we first installed the system, we rejected about 30% of all raw materials. You guessed it! Once the suppliers figured out their raw materials would be tested by us, they started shipping us ONLY their best. This means the other stuff goes to the suckers that don’t test!
Understand this: We are buying the very BEST raw materials available from the BEST suppliers in the USA!
HPTLC is the gold standard for testing herbs for identity. Many of the main US suppliers often get swindled into selling spent herbs. This means they are selling herbs that are left over from the extraction processes. You need to make sure that the manufacturer you choose protects you from this kind of practices.
Also ask the manufacturer how many standards they have on hand to test against on their HPTLC. If they only have 4 standards, then they can only test 4 supplements for identity. We have well over 200 standards and our library is growing.
Ask for a proof!
Ask to be put in touch with the Lab Director and get him/her to email or text you cell phone pictures of your lab results. Please read our report that explains to you in detail what kind of proofs you should be asking for each lot. If you don’t put the time into asking for a proof that your botanical ingredients are tested on an HPTLC,then your product has a 10% chance of being a scam – and you a scam artist! Sorry, but that’s the fact of the matter. Ask for the proof!
HPTLC is better than DNA analysis:
There is a lot of propaganda against supplements, one of the most opportunistic and idiotic propaganda against supplements was when Attorney General Schneiderman of NY, needed to get more money run for some office (he later was booted out). So, what he ended up doing was to cozy up to big pharma by performing bogus DNA tests on herbal powders found in supplements nationwide. This is not the correct identification test because the DNA is already damaged when the plant has been dried and pulverized into powder. Only fragments of DNA are left at that point. Forbes later explained what happened in this article:
Therefore, even if a manufacturer claims to verify identity with DNA, do not fall for it. The only way to do so is with HPTLC.
HPLC is used for measuring potency and CANNOT be used for verifying identity of herbs and herbal powders with as much accuracy as the HPTLC system. Further do not be dubbed into the stupidity of verifying ID with FTIR. That is just outrageous! FTIR is used for verifying id of amino acids, vitamins and so forth, it should only be used as an auxiliary test method for raw herbs and herbal extracts.
Pictures from our laboratory and office:
2. What certifications do you have?
Judgment of quality is more easily determined by checking if the manufacturer is GMP certified (21 CFR 111.75). If they hold certifications from at least two of the organizations below then you can trust that they are audited at least two times per year. It’s NOT enough to be audited once per year! And remember to verify the certifications!
2. UL Certification by Underwaters Laboratory – www.UL.org
Verify Here: https://crs.ul.com/en/ul-registrar-certified-client-listing/
3. NPA Certification by Natural Products Association – www.NPAinfo.com
Verify Here: https://crs.ul.com/en/ul-registrar-certified-client-listing/
For more information; the regulation is described in 21 CFR 111.75 which can be found at: http://www.fda.gov – Make no mistake about it! Supplements ARE regulated. Choose a manufacturer that can PROVE they follow those strict regulations to the letter!!!!
3. Do you actually manufacture? And if you do, how long have you been in manufacturing?
This may sound like a silly question but we get this question all the time. Many of the largest contract manufacturing companies in USA actually contracts over 95% of their manufacturing out to other companies. This causes longer lead time but most importantly loss of control.
The worst thing is if you are buying from a “manufacturer” that does not manufacture their own products; he may not know exactly what’s in the supplements.
The longer a company has been manufacturing pure supplements without excipients, the more it has been able to learn.
Does your manufacturer have the expertise, skill and culture to manufacture pure supplements? Or are they just picking up on the trend now because it’s a popular? Knowing the answer to this question can save you headaches down the road.
4. Do you only use Pure Form of ingredients in My Product?
It is a common misnomer that if you take a certain mg amount of a supplement that it does not matter in what form it is, how it is packaged and with what it’s packaged. Take Vitamin C for example. You can get it in many forms and some are more absorbent than others. Even if you see “Ascorbic Acid” on the label of two different products, the ingredients can vary. One manufacturer may use 90% Ascorbic Acid with 10% Corn Starch and Lactose (for better handling in manufacturing).
Of course, a manufacturer that focuses on purity will use 100% Pure Ascorbic Acid. Unfortunately, this is true for lots of ingredients, including the following:
Our Raw Materials
Other Manufacturers’ Raw Materials
How it’s reported in the supplement facts box
|Pure Ascorbic Acid||90% Ascorbic Acid, with 10% Corn Starch and Lactose||Vitamin C|
|Pure Vitamin D||0.1% Vitamin D dilution in a base of Dicalcium Phosphate, Lactose, Acacia, BHT, Sodium Benzoate, and Sorbic Acid||Vitamin D|
|Pure Riboflavin||33% Riboflavin, with Mono- and Diglycerides of Fatty Acids surrounding each particle for better flow, flavor and masking||Vitamin B2 (as Riboflavin) mixed with rice flour for a uniform blend|
|Pure Vitamin B12 as Cyanocobalamin||Cyanocobalamin (0.1% B-12 dilution in a base of Corn Starch with Sodium Benzoate and Sorbic Acid)||Vitamin B12 (as Cyanocobalamin) mixed with rice flour for a uniform blend|
|Pure Biotin||1% Biotin diluted on a base of Dicalcium Phosphate, Lactose, Sodium Benzoate, and Sorbic Acid||Biotin|
|Pure, Undiluted Pepsin||Pepsin, standardized with Lactose||Pepsin|
|Pure, Undiluted Pancreatin||Pancreatin, standardized with Lactose||Pancreatin|
|Pure, Undiluted Bromelain||Bromelain, standardized with Lactose||Bromelain|
|Pure, Undiluted Papain||Papain, standardized with Lactose||Papain|
5. What kinds of testing do you perform?
It is a good sign if the company has its own in-house lab. It means that they take quality control seriously.However they also need a dedicated person for Quality Assurance. QA takes care of the process and QA takes care of potency and purity.
Raw materials must be tested EVERY TIME in accordance with cGMP regulations. Outsourcing all lab tests is prohibitively expensive. Therefore, it is a clear sign of poor quality if the manufacturer does not have an in-house lab – and it’s not enough to ask! Go look!!! Ask to look in their lab note books. If they say they keep all the information in their computers, then be suspicious. Per GMP you need to keep the info in lab books with numbered pages and each experiment must be signed.
What equipment is in the lab?
It is common that the “in-house lab” only consists of a coliform stick. This is unacceptable. Also make sure they are using the lab equipment they show you. Ask to talk to the lab director or the person who will be conducting the tests on your products. Here are questions to the in-house lab. (Make sure your account representative does NOT answer those questions – insist to talk to the Lab Director).
6. Does the company follow FDA’s cGMP SOPs?
Talk is cheap. Action is golden. The kind of company you want to work with should painstakingly follow all SOPs. Ask to be taken on a tour around the facility and then when you see some production workers taking powder or capsules from a container, do a quick inspection. Check if the container has three stickers on it. All raw materials should have:
• Quarantine Sticker
• Testing Sticker
• Release Sticker
Also, ask your contract manufacturer to show you examples of Production Records that have been filled out by their staff.
7. What is the company’s communication style, will it work for you?
Don’t get hooked on a contract manufacturer if they don’t communicate with integrity and not on time, let alone if they lie to you about what they put in your product! It isn’t unheard of. When some contract manufacturers run out of one ingredient, they simply replace it with another! WITHOUT TELLING YOU! This means your product can cause harm! Your label is incorrect! Your product becomes liable to confiscation by FDA. You don’t want that!
If the company does not inform you of production schedules upfront then don’t work with them. Of course they will not hesitate to sign an NDI. But more importantly, because NDI is just a piece of paper, do you trust that the heads of the company won’t “give” your formula to others? The last thing you want is your formula being used in competing products!
8. Will you protect me against PROPOSITION 65 and the resulting financial losses and recalls?
You don’t want to get caught in this trap by working with a company that doesn’t know the proper testing to comply withCalifornia’s Proposition 65. If they don’t have an ICP then they can’t test your product in-house. Are they able to calculate and inform you about the proper dosage allowed for your formulation?
9. Will they give you guidance on label regulations?
An experienced contract manufacturer can help you with your label, although the ultimate responsibility of the label rests in your hands, and no one will have studied it more than you.
Ask them if they think your “Structure and Function” claim is up to par. What documentation do you need to have handy to substantiate your claim? Is your supplement box correct?
10. Will they try as hard as possible to avoid unnecessary excipients and lubricants?
If you don’t want those things in your product you shouldn’t be forced to accept it. Here is a list of additives you may want to be without. Whatever your opinion is on this issue, it makes good marketing sense to avoid anything that may be objectionable to the consumer, such as:
• Titanium / Silicon Dioxide
• Cellulose, Silica, Stearic acid and much more…
As reported by Natural Foods Merchandiser: “Consumers want clean labels with words they recognize, and the fewer ingredients the better.” You need all the help you can get to market your products. Don’t let your contract manufacturer convince you that you “NEED” to put one of those nasty things in your products.
Customers don’t want ingredients they don’t know or recognize, such as magnesium stearate, titanium / silicon dioxide, cellulose, silica, stearic acid, colors, methyl paraben, propyl paraben and so forth. Rather have them change the formulation and use only flow agents that are less controversial such as organic rice flour.
The avoidance of hard to understand and possibly toxic manufacturing agents is a definite trend that has taken years to form and will not go away.
11. Do they Clean with Toxic Chemicals?
If you want to minimize the possibility to getting complaints fromhypo allergenic customers then ensure your manufacturer does not clean with potential allergens.
Many companies use laundry bleach like CHLOROX, this is obviously a bad idea because it often contains extra chemicals, for example “bluing agents “made from dies that many say can cause big problems when trace amounts are ingested. Most brands of Clorox are not certified safe for food but are available in every store so many companies use it instead of NSF grade food safe bleach.
“Simple” Green contains: Tetrasodium N,N-bis(carboxymethyl)-L-glutamate, Sodium carbonate, Citric Acid, Colorant (GREEN), Fragrance. Simple enough but if trace amounts of those chemicals get into the supplements can they cause allergic reactions in a chemically sensitive person?
We recommend you only clean with edible cleaning solvents. We at Pure NSM use two cleaning solutions we make ourselves: “Black Death” made from iodine and grain alcohol and “White Death” made from ammonia and gain alcohol. In case you are wondering… Ammonia is used in many foods, for example cheese and cookies.
12. Will they drop ship the products for you?
If you ever want them to ship directly to your customers, make sure they can do this for you. The fact is that FedEx, UPS and others do not allow “fulfillment companies” to charge low shipping rates. Only if the company sold you the products can they charge you the low rates. The carriers do that in order to protect themselves.
As an example, if you take your product to a fulfillment house they will have to charge you $5 whereas if you have your manufacturer send the product they can do so for $3. The savings add up.
You Have ONE CHANCE to Make a