Jim Lassiter -- Good News/Bad News

It Isn't Paranoia if They Really Are Out To Get You

jlassiter@att.net — Fri, 02 May 2008 17:52:00 GMT

The latest evidence from the actions of a pharma company should give one pause. There is a legitimate danger ahead and we need to be more than naïve about the future. If you think restrictions on weight loss claims would be bad -- what about restrictions on CALCIUM claims?

A Suitcase Nuke from Big Pharma -- Just In Time for Spring

jlassiter@att.net — Fri, 25 Apr 2008 20:13:00 GMT

One of the members of the entity we like to call "Big Pharma" just sent a citizen's petition to FDA. This has the potential affect roughly the size of a small nuclear device on this industry. Want to find out more? Read on.

These Remarks Were Taken IN Context

jlassiter@att.net — Tue, 15 Apr 2008 15:21:00 GMT

The Commissioner of the Food and Drug Administration just initiated a kind of weekly Blog within the FDA Website. You really ought to see what his first posting said. Or you can read the summary here.

Last Words on Words

jlassiter@att.net — Fri, 29 Feb 2008 17:33:00 GMT

This last is a series of three spews about words and the impact they have on our industry points to some other definitional issues we, as an industry, would have if we were paying attention.

The Other Edge of the Sword

jlassiter@att.net — Thu, 17 Jan 2008 19:20:00 GMT

This is the second of three installments concerning words, language, identification and how these simple tools affect our industry, the direction it is headed and current situations involving our industry.

Words, words words.

jlassiter@att.net — Thu, 17 Jan 2008 04:52:00 GMT

This is the first of a new series that talks about words and how their use affects this industry and what we should be aware of as an industry going forward. That is -- before the words we can use are chosen for us.

The Long Hot Summer of the Wild, Wild West

jlassiter@att.net — Thu, 06 Sep 2007 02:49:00 GMT

Amazing what this last summer brought. Here's a little reminder that out here in the Wild Wild West -- sometimes you have to be careful what you wish for -- you just might get it -- plus a little bonus.

The Other Shoe OR -- Summer Reading Selections

jlassiter@att.net — Fri, 22 Jun 2007 19:12:00 GMT

Guess what? The Final Rule on Dietary Supplement GMPs just went out in pre-publication form. Now what? First there is reading and digestion of what has come out -- followed by discussion and mutual learning as we go forward. In the MEANTIME though -- like a book jacket -- here's the first thoughts on the matter. See you at the beach with your copy of the Federal Register Notice on our laps.

Do as I SAY, not as I SAID

jlassiter@att.net — Fri, 04 May 2007 03:59:00 GMT

I suppose it's an annual event with me but here it is Spring and the matter of Claims for Dietary Supplements has come back to my focus. As the industry gathers once more for a confab -- maybe someone ought to think a bit about what is going on with Claims Structures in the United States and thnk further about what the industry can DO about it.

Neither a Borrower nor a Lender Be . . . .

jlassiter@att.net — Sat, 14 Apr 2007 01:26:00 GMT

Old proverbs like old shoes are comfortable and oftentimes useful. This topic is far from new. The discussions around the practice of using someone else’s good work to support your own efforts have been around for years. Maybe because it’s Spring and the sap is rising or maybe for other reasons the topic floated into my consciousness just now.

When a company, entity or even independent researcher invests at least time, if not substantial amounts of money, to gain scientific insight as to the benefits of their product, the output really belongs to those who put up the effort. Yet each day in every health food, retail and mass market store in the country the usurpation of these efforts is put right in front of the eyes of the consumer. The classic term for this is “borrowed science.” Using the substantiation that exists for the benefits of a specific compound to polish one’s own image is just wrong. Now, that we’re clear on my perspective, let’s look at some clarity and possible actions.

As for clarity, while it hasn’t happened yet, there is potential for companies to shout about their science being borrowed when the actual data exist on more generic forms of a compound or material. Just so we don’t confuse the issue, we should all be aware that there is plenty of science just “lying around” that points to benefits of compounds found in supplements which can be classified as “generic.” These substantiations are available for everyone and belong to those who employ the same compounds (generically) and at the appropriate levels. EGCG is as good an example as any. This material presented at appropriate levels (270 mg per day) can assist in the process we call “fat-burning.” You want to make the claim? Put the right amount of the material in your product. No trademark issue, no cause for concern, no borrowing and you have a pretty decent claim to make.

The flip side of this is when there is a specific compound, developed at considerable expense and substantiated at even greater expense that gets “genericized.” The use of the data and even the inclusion of the scientific evidence in “substantiation files” sitting in file cabinets around the industry members are just wrong. If I use a specific, trademarked, if not patented, material in my formulation to gain the advantage of the science behind it to make claims – I should be righteously angry when someone else makes the same claim but does not use the specific ingredient tested. This is in addition to the fully righteous anger that the maker of the material studied feels but therein lies the rub.

When folks wail about “borrowed science” too often the cries are heard from the makers and suppliers of the specific materials. Not from the buyers and incorporators of the material. The action item here then to consider a strengthened alliance. If you or your company invests in finding, evaluating the data and chooses to incorporate a specific ingredient in your product – why not fully ally with the supplier of the ingredient. Make it known that you will similarly not tolerate the borrowing of the science behind the ingredient. This action is as opposed to believing (or hoping) that your marketing of the product with the special ingredient will outpace your competition. The suggestion here is that the makers of the ingredients who take the time to develop the science behind the claims strongly suggest that whoever buys the material take on the added responsibility of assisting in defending the science behind the claim. There are avenues available for this. Consider the NAD – you know that industry “self-regulation” arm of the Better Business Bureau that has recently turned increased attention toward the dietary supplement industry. If a company spends the extra dollars for a trademarked ingredient why not alert the NAD about a competitor who is using the same claims (inappropriately) for the generic form of the ingredient? Further, why does the seller of the ingredient ask the buyer to help in this effort? Sure, it’s a bit distasteful to turn in one of your own industry members, but if the industry wishes to self-regulate, there are decisions that have to be made and actions taken in order for the “self” part of the phrase to truly work. Another benefit of this is that companies can become educated rapidly concerning the validity of the substantiation for their claims and whether such substantiation applies to a specific, trademarked ingredient or generically. This would become part of the buyer/seller dialog.

Imagine sitting with a company representative and asking whether the science being presented in support of the claims you wish to make about the material they wish to sell you is applicable EXCLUSIVELY to this material. Then imagine that if the answer is yes, that you as the buyer now assume additional responsibility to protect your investment (the purchase cost of the trademarked item versus the generic) and that you are willing to aid your own marketing cause through a self-regulatory effort involving your competition. Yes, it does mean that you have to get your own house clean (or replace the glass house with one made of more substantial material) before you cast the first stone – but what’s wrong with that?

Anyway, our continued reliance on borrowing the good work of others has to stop somewhere. There’s an avenue for it. There’s a potential for cementing business relationships out of the efforts. There’s also the opportunity to make some very distinct claims about your products while insuring that the extra costs you incur are rewarded. Such efforts are worthwhile, I believe, and forming or redefining the partnerships that exist between raw material suppliers and raw material users can only be of benefit. It continues to be my view that this industry is based on relationships and strengthening those relationships can only help.

Now – back to Spring Break.