EXPERT DIETARY SUPPLEMENT DEVELOPMENT/FORMULATOR

By Pete Maletto

Of course after being in the dietary supplement industry for so many years I'm fortunate to know about every herb and its active ingredient, vitamin and mineral, how it works, what it does, and how long it takes to see a difference. It was my work experience in multiple areas of the business that made me an expert in nutraceutical science and dietary supplement development.

The next step is putting the capsule/tablet/powder together in a formulation on spreadsheet that I specifically use for dietary supplement development. With this spreadsheet I put in all the well researched vitamin, mineral and herbal ingredients and put in the efficacious amounts of each ingredient on a milligram basis.

We also have to formulate on total ingredient vitamin content, elemental mineral contents, and active constituents in the herbal ingredients based on HPLC analysis (testing methods that ensure accuracy of active ingredient).

Of course, there are several questions I have to ask myself at this design point. How many capsules/tablets/powder will it take to make a difference in the person taking the dietary supplement product? Will it need to be taken with food or do the ingredients require an empty stomach? (many nutraceutical ingredients require no food present)

This is when you have to go back to the scientific research and look at the various doses and methodology used during successful clinical studies. It's almost like putting the pieces of a puzzle together, taking note of the condition you are formulating for and which nutritional deficiencies relate to the disease. The ingredients are then calculated and my spreadsheet automatically configures formulation percentages and costs associated with each ingredient.

FORMULATIONS FOR LEGAL DIETARY SUPPLEMENT CLAIMS

I'm sure we have all read about companies being fined millions of dollars by the FTC because of false claims based on their products. Most of this is ignorance based on the lack of knowledge of the ingredients in their very own products, and the lack of experience in how to structure an effective marketing campaign using claims that follow regulatory guidelines.

It's actually pretty easy. The law states that you cannot make a disease claim on the product such as cures cancer, reverses diabetes or cures influenza. Cancer, diabetes and influenza are diseases that you cannot even mention on a label regarding FTC guidelines.

You can start your campaign by looking at the disease your trying to support change with and then using structure function to support your claim. Rather than saying cures cancer you would utilize the phrase "supports healthy immune function", or for diabetes "supports healthy blood sugar", or for influenza "supports seasonal wellness".

These are examples of legal claims that you can make for your product. One of the best example I have seen refers to a garlic product, which the company is using the legal tagline "cholesterols bitter enemy" rather than saying lowers cholesterol. The legal line is so well thought out and creative it's actually better than saying the product lowers cholesterol.

This is also where the ingredient research we initially did comes into use once again. For example, say we develop a weight loss formula and we just want to utilize the claim "boosts metabolism" for our marketing campaign. Well then you better have the research to back up the ingredients your using and what you based this conclusion on. This is why doing the due diligence on your nutraceutical formulation is critical to your companies safety and longevity.

The worst example was the company that made Cortislim. Their advertising was very deceiving (but convincing) and the claim that "cortisol causes belly fat" was never scientifically proven in any studies with the ingredients or the product as a whole. They were fined over 50 million dollars for their false and misleading claims that "cortisol causes belly fat" which could of been avoided by just making a truthful claim that "stress causes eating disorders that promotes weight gain" and then showing the tons of scientific evidence that exists to support that claim. Then the shameful part is that Cortislim does not reduce cortisol or even come close to it. In fact, it contains caffeine, which increases stress and produces more cortisol.

I usually like to have over a dozen scientific references that are conclusive to a marketing claim. If applicable, I also like to conduct small independent pilot studies on the product to backup the scientific research. The whole idea is to provide conclusive evidence that your product does exactly what your claiming. I like to say a good defense is your best offense!

READYING YOUR NEW DIETARY SUPPLEMENT PRODUCT FOR MARKET

By now we completed the research and formulation on your dietary supplement and we are set for labeling. Nutraceutical labeling also has a set of rules that must apply in how you list the ingredients.

When listing the ingredients you first must isolate the vitamins and minerals in the formula and list them first in the required "Supplement Facts" regulatory guidelines. This requires listing vitamins and minerals in a specific order and calculating the percentage of the recommended Daily Value (DV).

After those calculations are made then you can list the herbal ingredients and the percentage of their active ingredient. For example, Saw Palmetto Extract (standardized for 45% fatty acids) listing the herb and its active ingredient.

Then of course you list the recommended use and include any allergy warnings or guidelines that may be associated with taking the product.

We then have to make a decision based on the type of packaging you want for your product. Some of my clients want blister pack/box and others are just happy with bottles and I usually recommend plastic over glass.

At this point we then start quoting the formulation to several prequalified private label dietary supplement vendors that we work with. These private label facilities we work with have a high quality control standard and can produce your dietary supplement to ensure the effectiveness you require for a repeat customer.

At PTM Consulting we can manage your entire dietary supplement process from concept to research to costing to finished product. Please contact us if you have any further questions, well be glad to help.