Why Choosing a Faster and Cheaper Supplement Manufacturer Doesn't Work
After working in the dietary supplement industry for roughly 20 years - and many of those years involved formulation and contract manufacturing - I can definitively tell you that selecting the fastest and cheapest supplement contract manufacturer is often the worst option. Allow me to explain myself, starting with a high-level overview of the typical manufacturing process with a contract manufacturer (CM).
The Contract Supplement Manufacturing Process
The following is how a GMP-compliant dietary supplement is supposed to be produced:
- Customer submits a a request to receive pricing from the CM.
- The CM provides the price quote to the customer.
- The customer submits a purchase order (P.O.) to the CM.
- CM orders the required raw materials from suppliers.
- Raw materials arrive at CM.
- Raw materials go into quarantine and are tested.
- Upon successful passage of tests, raw materials are released from quarantine.
- The CM conducts bench work to determine the viability of the formula in a finished product.
- Depending upon the situation, the CM may provide samples of the product being manufactured to the customer to evaluate.
- Customer approves samples.
- CM runs pilot batch prior to production run.
- CM runs production batch and packing of finished product.
- CM conducts testing of finished product according to specifications.
- Customer approves finished product based upon visual inspection and certificate of analysis.
- CM ships product to customer's distribution facility.
So, how long do you think this entire process typically takes for a new custom order?
The answer is 12-16 weeks from the date a purchase order is received to the time a product is completed. Depending on the contract manufacturer, re-orders can typically be completed in 8-12 weeks.
Why does this take so long? Most of the time it has to do with placing orders for the raw materials and waiting for them to arrive.
What's the Process for Ordering Raw Materials for Dietary Supplements?
A well-formulated dietary supplement often contains one or more hero ingredients in addition to other nutraceutical side-kicks. These hero ingredients tend to have good human clinical studies behind them, allowing brand owners to make compelling structure/function claims about their product(s).
Not surprisingly, these hero ingredients also tend to come with a higher cost per kg than alternative ingredients which some contract manufacturers may offer as cheaper alternatives, but such ingredients generally come without research to support claims. In any case, hero ingredients may come from domestic or international sources, and they may take some time for your contract manufacturer to receive them after a P.O. has been placed.
As an example, let’s say that the ingredient in question is a probiotic. As live microorganisms, probiotic ingredients are typically made to order. They literally must be grown on a natural medium, and that doesn’t happen overnight. In fact, growing probiotics may take six weeks or so. Now let’s say those probiotics come from Italy (which is often the case), so that means the finished material will be shipped internationally - which typically takes 1-2 weeks.
Isn’t there a simpler and cheaper way?
There’s always an alternative. You could instead choose a probiotic material that the contract manufacturer already has in-stock, which means no additional waiting time - but stop for a minute and think.
Probiotics are alive and have a limited lifespan. If they’ve been sitting on a contract manufacturer's warehouse shelf for months, it is very likely that they have experienced a serious loss of potency. That means that by the time it is put in a finished product, the probiotic may have little or no activity. In turn, that means that your product will be ineffective, and any claims that would have been based on the probiotic can no longer be substantiated.
What's the Process for Testing Raw Materials for Dietary Supplements?
cGMP regulations require that raw materials be quarantined once they arrive at a CM, and further that they be tested. So what’s involved in testing? A raw material must be tested for the following:
- Identity and potency
- Microbiological compliance
- Heavy metal compliance
To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia, or provided by some other credible source. Not only must that methodology be followed, but a standard will need to be purchased if the contract manufacturer doesn’t already have the standard. If you didn’t already know, a standard is a validated sample of the raw material ingredient that the CM’s laboratory will use for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment (e.g. HPLC) to see if it matches. In that way, identity and potency can be established.
Next, the raw material must be tested for microbiological compliance to verify that it does not contain dangerous levels of microorganisms such as E. coli. Special equipment in a separate microbiological laboratory will be required for this purpose. Since every contract supplement manufacturer does not have an in-house microbiological lab, this may mean that the raw material will have to be send to a third-party lab for micro testing. In fact, some contract manufacturers do not even have a standard analytical lab, so all testing will have to be conducted by a third-party lab. Obviously, you have to factor in additional time (maybe 2 weeks) when a raw material is sent out to a third-party lab for testing.
Finally, heavy metal testing for lead, mercury, cadmium and arsenic must also be conducted. Not only is this required and the right thing to do anyway, but California Prop 65 requirements are associated with some hefty fines if your product fails to meet their more stringent heavy metal requirements.
Additional Considerations for New Brand Owners
From these examples, you can see how the ordering and testing of raw materials can impact product production timelines. But let's be honest, would you personally want to take a product or give it to your family if it hadn’t undergone all these tests? Now consider that raw material ordering and testing are only one factor affecting costs and timelines. Additional testing and quality assurance measures take place throughout the entire production process, each having their own impact.
My Final Piece of Advice for New Brand Owners
So, if the supplement contract manufacturer you're speaking to provides you with or promises significantly cheaper pricing and a faster product completion timeline than other service providers, that should raise a red flag.
At the same time, you should be asking yourself (and them depending on your personality) the following questions:
- Why are they faster and cheaper than the other contract manufacturers I've spoken to?
- Where are they potentially cutting corners?
- Are they using sub-standard raw materials?
- Are the conducting all of the necessary testing on product?
- Are they compliant with cGMPs?
The old adage, "You get what you pay for" is never truer when it comes to the production of dietary supplements. As a brand owner, can you afford to risk your company’s reputation by placing purchase orders with a contract manufacturer who offers cheaper costs and faster production times that are not consistent with the creation of quality products based upon cGMP compliance? Be smart in your choices. Your brand and its reputation (as well as your own reputation) depends upon it.
Looking for more information on this topic? Over 1,500 aspiring brand owners have read our 6 simple tips for selecting the right dietary supplement manufacturer. Check it out now!