Steps to Successful Product Formulation

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 subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

Evelyn and Associates

Bioscience Translation & Application                 www.BioTransApp.com

FDALabels.com                                                    www.FDALabels.com

 

Revised FDA Guidance on Cosmetic GMPs

The weather is changing as a new season begins and it’s time to review recent FDA activity in the cosmetic sector.  In June 2013 FDA published a draft guidance revising the Good Manufacturing Practices for cosmetics. While these GMPs remain voluntary, FDA Agents will use these guidelines when inspecting cosmetic facilities.

FDA first published cosmetic GMP inspection guidelines in 1997 and updated them in 2008. FDA participates in the International Cooperation on Cosmetic Regulations (ICCR) and this latest update incorporates portions of the International Organization for Standardization’s (ISO’s) current standard for cosmetic GMPs (ISO 22716:2007)

The new guidance expands the section on documentation and record keeping; placing this information at the beginning of the guidance.  The sections on facilities, equipment, personnel, raw materials, production and laboratory controls are expanded as well.  There are new sections on water used as an ingredient, color additives and prohibited cosmetic ingredients. 

The section on water used as a cosmetic ingredient states in part that the water is to be of defined quality and is to be tested or monitored to verify that it “meets applicable chemical, physical and microbiological specifications for quality”.  It is also noted that the water system “should be routinely cleaned and sanitized according to an appropriate SOP that ensures no biofilm build-up.”

Surprisingly, the new guidance omits the section on labeling that was included in the older version.  It is unlikely that FDA inspectors will skip label reviews during an inspection since labeling requirements are codified in regulations.  

Although the revised draft guidance does not have the force of law, if it is followed, it can help you ensure that your production facility would pass inspection.  The full guidance may be viewed at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm353046.htm?source=govdelivery.

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Kind regards,

Evelyn & Associates

www.BioTransApp.com

www.FDALabels.com

 

NIH's Dietary Supplement Label Database

Earlier this summer the US National Institutes of Health (NIH) launched the Dietary Supplement Label Database (DSLD).  This website provides label information from supplement products marketed in the US. The database is easily searchable by ingredient, product name and company name and provides a summary of information on the labels as well as label images.  Based on my casual perusal of the database it is clear that very few of the labels would serve as good examples of compliant labels.  Nevertheless, the database has been made available to help medical professionals and researchers know what products are on the market in the US.  It may also serve as a tool for supplement manufacturers wishing to do a bit of market research.

I contacted the NIH with a few questions about this website and received the following response from Therapeutic Research, the contractor responsible for adding and updating dietary supplement labels for the DSLD:

“The primary way we gather and keep labels up to date is through our Manufacturers Connect program. Through this program, we pair one of our research associates with each manufacturer or distributor of dietary supplements. The research associate will contact the company at least annually to determine if there are new or updated products. Additionally, this provides the manufacturer with a single point of contact through which they can notify us of any changes to their formulations.

We ask manufacturers to send us a current list of all dietary supplement products and a clean image or physical copy of the product label for each of the current products. Then our staff will add all of the new products and review any existing entries to ensure the entire product line is up-to-date in the DSLD. We like to have a point of contact with each manufacturer that we can reach out to with any questions that may come up during the entering/updating process. Manufacturers often reach out to us when a product is launched, reformulated, or goes off market. This allows manufacturers to ensure their entries are current throughout the year and not just during the annual review process.”

You may already know whether your labels have become part of this database. Nonetheless, you may follow this link to view the database: http://dsld.nlm.nih.gov/dsld/index.jsp

We at Bioscience Translation & Application and FDALabels.com are ready to help you with your FDA compliance needs.  We send these posts via email to our subscribers.  If you would like to subscribe to our emails on dietary supplements, cosmetics, foods or over the counter drugs, simply reply to this post.