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How to Create a Dietary Supplement Formula

How to Create a Dietary Supplement Formula Like a 40-Year Pro

If you're reading this article, chances are that you're either thinking about or have already made the decision to launch your own nutritional supplement company.

After you've determined who your target audience is, finalized your customer acquisition strategy, and conducted a thorough competitive analysis (we cover all of this in more detail in our simple 10-step guide to starting a supplement company), the next step in your entrepreneurial journey is to identify and finalize your product offering. 

But, how do you make a dietary supplement? For starters, you could follow one of these formulation strategies:

  1. Formulate the cheapest possible product, without regard to scientific substantiation for any claims. Chances are that most or all of the nutraceuticals present will be "fairy dusted" into the formula.
  2. Formulate a product containing a clinically relevant dose of at least one nutraceutical, providing scientific support for claim substantiation. In this instance, there may also be fairy dusting of some nutraceuticals.
  3. Formulate a product containing clinically relevant doses of all nutraceuticals present, providing scientific support for claim substantiation and no fairy dusting of nutraceuticals.

I'm going to dive into the benefits and drawbacks of these tactics in more detail below and then explain the process of how to create a dietary supplement formula using my 40+ years of nutraceutical formulation experience. Without further ado, let's dive right in!

The Concept of "Fairy Dusting" and Nutraceutical Formulation

Before discussing each of these formulation strategies, allow me to define what I mean when I say fairy dusting. Fairy dusting is a term that describes the practice of adding one or more nutraceuticals to a formulation at doses that are below those shown to be effective.

For example, let’s say that you plan to include a specific Boswellia extract, and let’s say that in human research it was shown to be effective for joint comfort at doses of 100-200 mg. If you decide to include it a dose of 10 mg, then you have no scientific basis for supporting a claim for efficacy.  In fact, if you decide to include it in a dose of 99 mg, you still have no scientific basis for supporting a claim for efficacy - although arguably, the 10 mg dose is a far better example of fairy dusting.

How about the “synergistic potentiation” argument? This theory says that it’s okay to use a lower dose of a given nutraceutical if you combine it with some other nutraceutical that has a similar function. I've been in this industry for a long time, so I have no problem saying that simply doesn't fly. Unless you have a study showing that, when combined with some other nutraceutical, the lower dose is effective, this practice is still fairy dusting and there is still no scientific basis for supporting an efficacy claim.

Of course there are many proprietary blends in dietary supplements with a milligram amount for the total blend, but undisclosed amounts of its component nutraceuticals. Let’s be honest with each other. Although companies often claim that the reason for the proprietary blend is to protect their intellectual property, the real reason is that most companies create these blends is so that they don’t have to disclose whether each nutraceutical is present in a clinically relevant dose. So generally speaking, using proprietary blends is also a way to hide fairy dusting.

Formulate the Cheapest Possible Dietary Supplement

The only advantage of this formulation strategy is that your cost of goods will be very low, which gives you the opportunity to maximize your profit. Conversely, the disadvantages are that:

  1. You won't have sufficient amounts of any nutraceutical necessary to substantiate claims (a regulatory ticking time bomb).
  2. The product won’t likely have any efficacy.
  3. The lack of efficacy will likely translate to poor repeat sales.
  4. This will all likely reflect poorly on your brand and your brand’s reputation.

As a dietary supplement brand owner, it's important to remember that people will ultimately ingest your product. You have an obligation to protect them and provide them with the high-quality product possible. Cutting corners to make a few extra bucks will ultimately backfire and lead to your downfall.

Similarly, choosing a faster and cheaper dietary supplement manufacturer doesn't work and is a situation you should avoid at all costs. Our Vice President of Contract Manufacturing, Vincent Tricarico, said it best:

"Finding the right supplement manufacturer takes time - and that's okay. If there's any aspect of the dietary supplement manufacturing journey worth investing time and effort into, it's this."

Formulate a Dietary Supplement Containing a Clinically Relevant Dose of At Least One Nutraceutical

In my expert opinion, this strategy is the minimum acceptable approach to formulating a dietary supplement. By including at least one—but hopefully two or even three—nutraceuticals at clinically relevant doses, you gain the following advantages:

  1. There will be a sufficient dose of those few nutraceuticals to substantiate claims.
  2. Sufficient doses mean that consumers are likely to experience some positive results when using your product.
  3. Consumers experiencing positive results will likely translate to repeat sales.
  4. This will all likely have a positive effect on your brand and your brand’s reputation. After all, people love to post product reviews on popular platforms such as Amazon and Google.

The only downside is that your costs of goods will be higher than with the first option, but these costs can still be controlled and can still translate to a downstream manufacturer's suggested retail price (MSRP) that is acceptable to consumers—especially if the product actually works.

Formulate a Dietary Supplement Containing Clinically Relevant Doses of All Nutraceuticals Present

Formulating a product containing clinically relevant doses of all nutraceuticals present is the gold standard strategy in dietary supplement formulation. Taking this approach means that:

  1. There will be sufficient doses of all nutraceuticals to substantiate claims.
  2. Sufficient doses of all nutraceuticals mean that consumers will almost certainly experience positive results when using your product.
  3. Experiencing such positive results will almost certainly translate to repeat sales.
  4. This will almost certainly have a positive effect on your brand and your brand’s reputation.

The two disadvantages are that:

  1. Your costs of goods will be higher due to using clinically relevant doses of all nutraceuticals (which may be a roadblock to sales among some consumers due to a higher MSRP).
  2. The number of tablets/capsules needed to obtain the dose may be higher which may result in a compliance problem with some consumers. Nevertheless, if you want to produce the best possible product, then this is the formulation strategy for you.

The Process of Formulating an Evidence-Based Dietary Supplement

Assuming that you’ve decided on the second or third option as a strategy for formulating a dietary supplement, you will want to assure that you have the right doses of the right ingredients in your product to help assure an evidence-based supplement. If you don’t have a background in the science of nutraceuticals, I highly recommend that you utilize the services of a qualified formulation consultant or hire such an individual as a member of your corporate staff.

In any case, the dietary supplement formulation process should consist of the following:

  1. Find a trustworthy and experienced contract manufacturer (CM) to work with. They can help advise you on many of the following steps if you need help.
  2. Determine which structure/function claims you want to make for your product.
  3. Determine the nutraceuticals and their doses that will allow you to make the desired claims. This will require some research and reading of studies (PubMed is a good place to look for the studies).
  4. Decide if you want any special certifications or limitations on ingredients (e.g. non-GMO, gluten-free, clean label, etc.).
  5. Identify raw material suppliers that can provide the necessary ingredients reflective of those used in the studies, and that meet any certification needs.
  6. Create a formulation with doses of ingredients that won’t exceed your desired serving size (e.g. if you want your serving size to be two 00 size capsules daily, then you probably won’t be able to exceed 600-700 mg of total ingredients per capsule).
  7. Make sure that all of the ingredients will play well together (e.g. don’t try to mix oil-based ingredients with powdered ingredients, don’t mix antagonistic ingredients, etc.).
  8. Get your formula priced out with your CM, and make adjustments as necessary to accommodate dosing, serving size and pricing.
  9. Whatever you do, don’t just copy the competition’s formula. They may have made mistakes that you will just perpetuate. Besides, copying the competition gives you no point of differentiation with your products.

Conclusion

From the list above, you can see the that process of formulating a dietary supplement is not simple (at least not if you do it right). That’s the reason I propose that you utilize the services of a qualified formulator to help you with the process. To reiterate, a good CM can help you with the process, so choose your CM wisely.

January 24th, 2020

About the Author:

 
Gene Bruno

Gene Bruno, MS, MHS, RH(AHG) - Mr. Bruno possesses 40 years of dietary supplement industry experience. With a Master's degree in nutrition and a second Master's degree in herbal medicine, he has a proven track record of formulating innovative, evidence-based dietary supplements. Mr. Bruno currently serves as both the Senior Director of Product Innovation at Twinlab Corporation and Professor of Nutraceutical Science at Huntington University of Health Sciences.