Hello!
The trade magazine, Natural
Products Insider (NPI), recently published a slide show entitled, “Formulating
Successful Products in Six Steps”. While
the presentation focuses on the development of dietary supplement products,
similar considerations are helpful for cosmetic and food products as well.
The steps were written for brand owners using contract
manufacturers but also apply to companies doing in-house manufacturing.
The first step cited was to set finished product
specifications. Specifications define
the parameters for identity, purity, strength, and composition for the
product. Good Manufacturing Practices
require setting specifications to guide the manufacture of the product. You must set product specifications and also
have procedures in place to verify that the product is being manufactured to
those specifications.
The slide show contemplates a scenario where the brand owner
seeks help from the contract manufacturer’s formulator. It is important that your contract with your
manufacturer clearly states who owns the formula if you do use that
service.
According to the NPI slides the minimum specifications
include but are not limited to information to:
1.
Define the purpose or benefit of the product.
2.
Determine the form of the product -- for
supplements is it tablets, capsules, a powder?
For cosmetics it is a gel, lotion or cream?
3.
Determine what ingredients will be used.
a.
I’d like to add that it is important to think
about the availability of the ingredient and understand whether there are any
seasonal pressures on the ingredient availability. If you have an ingredient that is in short
supply during certain seasons, consider formulating with a mixture of the
preferred ingredient and its best substitute to stretch the supply and avoid
sourcing issues.
b.
It is also very important to write
specifications for whether ingredient substitutions may be made. It is also important to clearly define what
ingredients would be acceptable substitutions since these changes to the
formulation can affect manufacturing, product quality as well as labeling and
claims.
4.
Plan in advance which countries the product will
be sold in and be aware of regulations or restrictions that affect which
ingredients may be used.
5.
Determine whether some ingredients will be
required or prohibited. Desired label claims such as ‘natural’, ‘low fat’, ‘vegetarian’
or ‘gluten free’. Such claims will
affect costs and may affect which manufacturers will be able to make your
product. The claims that may appear on the final product label are determined
by the formulation.
The complete slide show and all six steps can be viewed at http://www.naturalproductsinsider.com/galleries/2013/04/slide-show-successful-formulations.aspx?cmpid=EM.
My associates and I can help you write specifications for
your product. We can also help you
research the regulatory status of proposed ingredients and review product
labels and marketing materials for compliance with FDA regulations. We welcome your questions.
I hope that you will find this information helpful. Please
use this link http://eepurl.com/Imbjv to
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other topics of interest to FDA-regulated companies. We send messages targeted to the dietary
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Evelyn and Associates
Bioscience Translation & Application www.BioTransApp.com
FDALabels.com www.FDALabels.com
