Nutritional Outlook Ask The Experts

My company manufacturers a very unique joint pain-relief formula. We’re distributing via retailers and are interested in exploring direct-marketing. What are the most important issues we’ll be facing?

jkwok — Fri, 18 Dec 2229 06:05:58 +0000

While there are a number of areas integral to your success in direct marketing, the big three are:

1. Creating marketing copy that carries a unique message enticing potential customers to purchase your product. Working with a skilled direct-marketing copywriter will be an investment critical to your success.

2. Honing in on the right prospects. If you put your new marketing copy in front of the right people, your sales will explode. A seasoned direct marketer will be able to look at your product, its price point and offer, and your new marketing copy and recommend where to find the prospects that you’ll turn into buyers.

3. Setting up your operations to take care of your new customers. Direct marketing to consumers requires that you are able to charge individual credit cards, bank check payments, fulfill product in a timely manner, handle customer queries and complaints, and report accurately on marketing statistics. Some of these systems you may already have in place, but ensuring they’ll all work in tandem as required is integral to your success.

DM360 has a Marketing & Operations Review process that we utilize with all of our clients getting started in direct marketing. It provides a blueprint that essentially becomes the direct-response business plan.

What are the best-selling nutritional supplements marketed through direct mail?

jkwok — Mon, 25 Oct 2010 17:42:01 +0000

While there are absolutely trends related to products via direct mail, much of the success can also be attributed to a strong creative piece and a strong Unique Selling Proposition (USP). Marketing copy with a compelling headline and lead paragraphs can pique a reader’s interest in many types of products.

At www.supplementmarketingmasters.com you’ll find a link to a product of mine that is a terrific education in all things direct marketing, but that specifically addresses how to choose a product for testing in this marketing channel.

Competitive analysis of the active nutritional supplement direct marketers shows the following as strong product categories:

Digestive / Colon
Cardio / Heart
Memory
Anti-Aging
Vision
Hearing

These are also popular but not as prevalent:

Hormone Balance / Thyroid
Allergy/Sinus
Kidney/Liver Cleanse
Breathing/Oral Chelation
Immune System
Diabetes

Is e-media a good tactic for manufacturers of nutraceuticals ingredients? Are manufacturers using websites and newsletters yet? Or would I be wasting my limited marketing resources using these tactics for promotion?

jkwok — Tue, 28 Sep 2010 23:04:41 +0000

Electronic marketing is a strong solution for business-to-business sales – for example, for a manufacturer selling specific ingredients to be used in a formulation, or for business-to-consumer sales, or for a manufacturer with a formulation being sold through other direct-to-consumer channels, such as retail, that wants to expand its marketing reach.

I suspect that this question is more specifically asking about business-to-business use of websites and newsletters. Creating a “free” electronic newsletter is a terrific tactic, assuming you can garner a significant number of qualified readers. This creates a relationship between you and your potential customers that is ongoing and tangible. Leads can be culled through a free-giveaway (i.e., “Top Ten Practices to Require of Your Manufacturing Source”) in exchange for an e-mail address, through a variety of sources such as Pay-Per-Click ads and advertisements on complementary websites. You can then communicate with these potential customers when you have special deals or special news.

Websites are integral to your marketing efforts both because when well-built and maintained, they provide your business with a significant amount of credibility and because they tell your story more thoroughly than you could ever do in a small advertisement. Your website must create a reason for the visitor to provide you with their information – it could be the same free-report giveaway and/or a brief survey of their needs completed online and responded to personally via e-mail or phone. Websites are a complement to your current marketing program, not a substitution.

Please feel free to contact me directly at stacy@dm360inc.com to discuss specific opportunities in greater detail.

Is it legitimate to retest raw materials that have passed their expiration date—and if so, what criteria do the FDA have for retesting?

jkwok — Wed, 01 Sep 2010 21:20:34 +0000

Yes, it is legitimate, in certain cases, to retest, thereby requalifying a raw material past its expiration date. Typically, industry may assign a six-month to one-year extension based on the retest results.

The product specification must still be met, and factors that may change over time must be assessed. These factors may include potency level, microbiological levels, polymerization, rancidity levels, and organoleptic properties. Many ingredients which inherently have a long shelf life are given expiration dates to trigger analysis for these very factors.

What is the best way to authenticate a suppliers Certificate of Analysis (COA)? What should I expect back from my supplier that will be acceptable?

jkwok — Wed, 01 Sep 2010 21:20:12 +0000

Really, the only way to authenticate a supplier’s COA is to perform the tests listed on the COA and compare results. This is something that you would need to do—not the supplier, as the supplier has already provided you with the COA. If you do not have an in-house laboratory capable of performing this testing, then you can send a sample to an outside lab. The lab should provide you with a test report indicating the results and test method used.

Our company is a wholesaler of finished products. We reside in the same building as our cGMP-certified manufacturer, but are separate corporations. The manufacturer supplies us with finished products, which are stored on the premises but separately from their warehouse. What cGMP rules apply to us as a wholesaler?

jkwok — Wed, 01 Sep 2010 21:19:52 +0000

As a holder of dietary supplements, you would be subject to 21 CFR Part 111. Specific requirements would include mechanisms for tracking and reporting recalls, returns, complaints, and adverse events; a record-retention program; and warehousing requirements, including sanitation and segregation.

If you are providing the labels for the products, then the labeling requirements found in 21 CFR Part 101 would also apply. NSF provides an auditing program for distribution and warehouse facilities with an audit checklist and guidance document specific to your type of operation.

Is there a base page that we can get various cGMPs to do on a quarterly basis, yearly, or monthly?

jkwok — Wed, 01 Sep 2010 21:19:32 +0000

As companies become more familiar with the requirements, current Good Manufacturing Practices (cGMPs) should be part of everyday business. cGMPs are ever-evolving, and one way companies can stay abreast of what is going on in the industry is to be part of a third-party auditing program such as NSF. Some companies try to break the regulations apart based on their subparts. However, I don’t think this is the best approach because some items need concentration daily, while others only once a year or maybe once a period.

I’ll try to address your question by giving you some best practices that I’ve witnessed. An annual systems audit, which addresses different parts of the regulations, is a good approach. The audit may include sampling a number of production lots and reviewing testing and manufacturing records, sampling a group of employees, and assessing the level of training or trending complaints and product returns. Annually, Standard Operating Proceduers (SOPs) could be reviewed for accuracy. Tasks that may be completed quarterly or monthly may include audits of sanitation, housekeeping, and employee compliance to SOPs.

Another good practice is to develop an ongoing training program that tackles different monthly topics related to product safety, refresher training on certain SOPs, industry awareness, chemical handling, HACCP if applicable, etc. As a set part of the training meeting agenda, companies choose to go over any customer complaints or product safety incidents from the previous month, review previous audit findings (from a third-party or housekeeping audit), and complete training on changes to documents, equipment, or facilities.

As a manufacturer, can we send a sample of an in-house blend to a lab for a Certificate of Analysis (COA), then take the same sample and use it as a calibration sample for our FT-NIR machine? Thereafter, could we test future in-house blends of the same product against the calibration for identification—then prepare a COA based on the positive ID, along with the lab’s results on file, and send this to our customers?

jkwok — Wed, 01 Sep 2010 21:18:57 +0000

First, let me make two points. One, the FDA says that the testing used must be “scientifically valid”—one of the few places in the CFR regulations where validation is used. Second, whatever you choose to do for testing (and the FDA leaves quite a bit of leeway here) must be defensible to the FDA auditor. You should keep those points in mind when designing your testing plan. So let’s take your proposal step by step.

The first part of your question seems to say that you want to use outside lab data in order to qualify an in-house reference standard that will be used for identity testing via FTNIR. This would certainly be allowable. Creating in-house reference standards is a common practice. You may choose to get multiple analyses done in order to qualify that standard and that would be recommended.

The second part of your question involves preparing a COA. You certainly could use your qualified in-house reference standard in your identity test method and report those results on a COA for your product. Your identity test method would need to be validated for the type of blend you are producing.

What tests would need to be performed on a vitamin and mineral premix that is going to be put into a powdered nutritional beverage supplement? If the mix contains 20 different vitamins and minerals, does the manufacturer have to test the mix for the identity of each of the 20 nutrients? If the manufacturer of the premix is already doing the identity testing on the components being used in the premix, does that satisfy the requirement of 100% identity testing?

jkwok — Wed, 01 Sep 2010 21:18:33 +0000

I assume that you are purchasing the blend. If that is the case, some sort of identity testing would need to be completed.

The FDA is very clear on requiring identity testing for all receipts of raw materials, without allowing skip-lot testing, as you point out. The NSF standard would also not allow you to rely on the blend manufacturer’s testing or Certificate of Analysis (COA) to identify the blend once the blend is received on your premises. I would suggest working with the blend manufacturer to determine a validated identity test that you could perform.

Do cGMPs for dietary supplements permit any type of reduced testing program for raw materials, other than simply relying on a COA from a qualified supplier? For example, can reduced testing frequency and/or the use of different specifications be applied to a raw material after a track record of passing test results has been established for a given supplier of a material? (This assumes that ID testing is always performed.)

jkwok — Wed, 01 Sep 2010 21:18:05 +0000

The FDA and cGMPs absolutely allow for skip-lot testing as part of your overall testing program. A skip-lot program would involve getting that track record you are referring to by performing the tests, and then after sufficient data gathering, reducing the testing for the entire lot of material or perhaps for one test on your specifications.

I would not advocate having multiple specs, but rather defining the skip-lot program as part of the spec or part of an overall testing plan standard operating procedure.

You are correct to point out that the FDA does not permit skip-lot testing for identity. So each and every lot of raw materials received will need to have this testing completed.