BY: BRUCE KNELLER

Giant Sports

Before I delve too deep into the topic at hand and alluded to in the title of this article, I want to take a moment to thank a few people.  First & foremost, I want to thank Marc Lobliner for asking me to write for his website, www.machinemuscle.com as a guest columnist. Marc is one of those “rare gems”, to offer advice and assistance in our industry. He does a lot more than “talk the talk” – having been at the helm as the CEO of a large sports nutrition company as well as competing as a National Level NPC bodybuilder, Marc Lobliner is well skilled in the theory and science in addition to the more pragmatic and realistic side of bodybuilding as an art. There aren’t a lot of guys like Marc out there and when he opines about something, he is one of perhaps a dozen or so people in the industry whose commentary I give serious credence to. He’s probably also one of maybe a dozen people I would reach out to for assistance or help if I had a particular question about something.

The other person I want to thank is David Plitt – who works in Sales for Europa Sports Products in Charlotte, NC.  David Plitt is a monster – the dude is jacked beyond…jacked! He’s also a heck of a nice guy who truly cares about his customers more than many other sales people I have met in the industry. Plitt is not “in it” for the quick buck.  Plitt is the type of guy who really wants to help his customers meet their fitness goals and who wants to establish long term relationships with people.

So here I am. Writing for MachineMuscle.com.  I will be writing for some other publications quite soon, I am not going to mention them here as that’s not fair to Marc or this website but for those of you who were waiting for me to be “back in the game” your wait is just about over. On to the topic at hand…

I like Matt Cahill a lot. Matt is another “good guy” in the industry. I am grateful that Matt Cahill exists and others like him such as Seth Roberts, Bill Roberts, Eric Marchewitz, & Patrick Arnold just to name a few, are present in our industry. The reason is these guys are all pretty darn good at what they do.  They are the best formulators and most innovative thinkers in the sports nutrition industry. I like these guys (some personally, some not so much personally) because they all keep me – a product formulator for many companies and many years now - on my “A” game all the time. I can’t be sloppy or lazy with these guys around or I am going to get beat bad.  Guys like Matt Cahill make me earn my keep.

They also make sure you – the consumer - gets the very best possible that the industry has to offer, that current science has to offer. Collectively, we all “push the envelope” a bit. But without such envelope pushing, you would all be relegated to the days of liver tablets, desiccated egg protein powder, and other very basic and ordinary supplements.  So like him personally or not (and for the record, I like Matt personally as an individual as well as when he has his “formulator hat” on) everyone should be grateful that Matt and people like him exist.

Recently, Matt & his company, Driven Sports, were hit with a Class Action lawsuit in the State of California.  If you have not seen it yet, you can click here (http://www.courthousenews.com/2012/03/21/Craze.pdf) to read a copy of the Complaint.  I am going to make some comments about this Complaint and what I feel are the circumstances surrounding it. Realize I am not an attorney and thus, I can’t offer legal advice to anyone.  So do not infer that I am doing anything other than voicing my opinion under the First Amendment, OK? These are merely my thoughts after “reading” this Complaint and talking with some rather prominent people in the industry behind the scenes who also think a lot like I do about it.

The most immediate thing that strikes me after reading this Complaint is that it is clearly being initiated and put forth by a jealous competitor of Matt Cahill, Driven Sports and the pre-workout product sold by Driven Sports called “Craze.”  For the record, I have tried Craze (and so has Marc Lobliner). I think it is an exceptional product.  When geranamine is banned – which it seems it will be by the time you read this for sure - Craze would have been situated to be the next really big thing in the PWO category. This is something I feel some of Matt’s competitors probably loathe and makes them green with envy. These folks have nothing to replace their PWO products sans geranamine that is of any merit and along comes Matt Cahill & Driven Sports with something that knocks your socks off – truly a “good feeling” product.  So I think this Complaint was likely seeded by a petty and jealous competitor because of how the Complaint reads regarding some aspects of DSHEA (more on this in a minute) and a few lines line in the Complaint that really stands out. Allow me to elucidate: (Editor’s Note-DMAA will probably be GONE in 30-90 Days–See Video Below!)

Line 1, page 9 – this reads on asking the Court for an Order enjoining the Defendant from continuing to engage in unlawful, unfair, or deceptive business practices…to me this means, “we want Driven Sports to stop selling Craze.”  Notice that this is the VERY first thing sought by the “Plaintiff & Class.”

Line 1, Page 12 – this also reads on the above seeking an actual injunction against the Defendant to cease and desist from engaging in unfair, unlawful and/or fraudulent practices alleged in the Complaint…again, I find it a bit peculiar that the Plaintiff is seeking an injunction to basically stop the sale of “Craze” as opposed to more specific damages being awarded to the Plaintiff and those “in Class.”

Exhibit I, Page 3 – this letter was sent by trackable courier to Driven Sports before the Complaint was filed.  In this letter, on this cited page, we read the following, “We respectfully request that you irrevocably stop all unlawful business practices and false and misleading claims with respect to the advertising, labeling, and sale of Craze.”

So to cite a line from Shakespeare’s Hamlet, “The lady doth protest too much, methinks!”

The certified letter to Driven Sports and Complaint has “jealous competitor” written all over it if you ask me. Because certain companies could not formulate a non-geranamine containing product to compete against Craze they decided the best thing would be to make Craze go away. Now with the exception of a few brazen whack-a-nut company owners in our industry who genuinely do not care if they are known as “the bad guy who filed the vexatious lawsuit merely to hassle the little guy out of business (e.g., Matt Cahill/Driven Sports)” most people don’t want to be the guy known as “the one who told on someone” especially in light of better than 80%+ of other sports nutrition companies probably not quite being “fully DSHEA compliant/GMP compliant.”

Such a person would not want his name associated with being the initiator of this lawsuit. Besides, as long as he can “hide” from sight as the root cause of this, he can chastise and make negative comments all day long about Matt, Craze, Driven Sports and the like in public view.

Quite likely, “that someone” sent an “anonymous” letter to the FDA and/or DEA regarding Craze and when no action was taken by either agency (none to date anyhow) the snitch just could not help himself and decided to pursue matters in a different manner – via a proxy class action lawsuit! How clever!

This type of case is very dangerous to our industry and is the obvious product of a very small minded, dimwitted, tactical thinking person who does not understand nor care about the damaging precedent that this could cause the entire industry if this case is allowed to stand and go forth “as is.” The case should be Summarily Dismissed and while I have not spoke with Matt Cahill or anyone else from Driven Sports about this case (nor do I have reason to) I would bet heavy money that whomever they have for an attorney will immediately move to have the case thrown out ASAP. I’ll get to the reasoning behind that in a moment but I want to discuss why this type of case is very dangerous to our industry.

If any individual person or company can file a class action or unfair trade case in a civil court that reads on some “alleged” violation of DSHEA, then anytime some individual/some company wants to know another company’s trade secrets/proprietary information about a certain ingredient they can merely file a frivolous lawsuit that reads, “Ingredient X in Company Yʼs Product Z is not DSHEA compliant – I want a judgment that makes Company Y removed the product from market and I want to be paid money because they cheated and this damaged my ability to compete fairly in the marketplace or I was defrauded because I thought I was buying something that has a legit dietary ingredient in it.” As the Defendant in a case like this, should the case be allowed to go directly into Discovery, you would be forced to show that the ingredient is indeed DSHEA compliant or likely to be viewed as such by FDA. And in doing so, you very well may be forced to publicly disclose highly valuable trade secrets/proprietary information to which then every competitor in the industry would be free to utilize in order to steal your idea.

The reply I have heard when I mention the above scenario is essentially, “Well why not file for a patent on your idea if it’s so good and such a secret?”  First and foremost, not all good ideas are patentable.  Intellectual Property Law is an esoteric and highly specialized area of law that is difficult at best for most people who are not career IP attorneys to really understand with depth or clarity. Merely having a good idea is not enough. The idea has to be both novel and non-obvious for any Claim under a Patent Application to be issued or it must possess qualities or imbue results that are atypical or “unexpected.” There may be a compound that is amazingly anabolic and obviously so. What may not be obvious is that it’s found in some ubiquitous foodstuff making it potentially DSHEA compliant. You can’t patent the compound or even a method of using it because it is obvious the compound builds muscle. So you can’t get a Claim awarded for it, as an Examiner would cite prior art showing the obvious anabolic nature of the compound.

Second, it takes years and a lot of money to be awarded Claims on a Patent Application. In the meantime, once your application publishes (or you start using the ingredient) you’re going to get companies out there who will blatantly rip it off and use it anyhow with the hopes that in 3-5 years you will not be awarded anything and even if you are? You still have to sue them to stop using the compound and obtain a “judgment for a reasonable royalty” for previous sales that might amount to 2%-4% of the infringer’s gross sales of said product.  I have a pending patent application for the use of Isomaltulose with Creatine. That has not stopped close to a dozen companies from ripping off my idea despite being warned in writing via my attorney to “knock it off.” When I am awarded any Claim to this, even one, I then have to sue these guys one at a time. That takes more time and money (but I am surely going to do it!). So the patent system is not the “be all – end all” most people believe it to be. It is slow, cumbersome and will not always afford you the protection and rights to an idea that you might think.

The Complaint as it stands now is faulty in my layman’s opinion anyhow. Line 1, Page 3 of the Complaint is entitled “Facts.” Line 8, Page 3 reads on the product being “adulterated…for reasons found in the Food, Drug & Cosmetic Act.” Oh really? This is a “fact?” says who? There are NO examples of this cited in the Complaint that I can find.  Speculation?  Sure. Fact? I don’t think so.

I do not believe an individual or a company has legal standing anyhow to challenge whether another company’s product is DSHEA compliant (i.e., the product is adulterated) unless the ingredient in question has already been declared not to be a dietary ingredient by FDA, a sitting federal judge, etc. To the best of my knowledge, an individual or a company filing as a Petitioner would need to have the ingredient/supplement declared non-compliant and thus adulterated by a sitting federal judge or in absence of that, at least an indictment/formal charge by the FDA, DEA, DOJ or at the state level, perhaps the AG of a “State X” levied against the Defendant alleging such BEFORE having any cause to seek legal action. This Complaint relies almost solely on the idea that an individual has the legal standing to haul a company into court to justify that their product is within the legal scope of a dietary supplement/ingredient per DSHEA. In other words, “I say you are guilty, now prove you are innocent!” I’m pretty sure that’s not how our legal system is supposed to work.

In a nutshell, I do not think that I nor you nor any individual/company has the legal standing to point a finger at a competitor company and cry, “that stuff they use is not DSHEA compliant!” and then drag the competitor company into court MERELY based on the personal belief that it’s not, in only our opinion, DSHEA compliant. As an individual or competing company, my belief is that all I can do is request the FDA or DEA or a State AG investigates the matter. It is up to the FDA/DEA/DOJ/State AG to decide to file a Complaint for some violation(s) of the FFD&C Act regarding something being “adulterated” or “misbranded” or to decide not to. That’s as far as we get to take it as individuals/companies.

Analogies

1) You’re on the highway doing 70MPH and some guys blows by you doing 130MPH or more. You can’t pull the guy over and hand him a Summons charging him with Reckless Driving. Hey buddy, I’ll see you in court in two weeks to answer for this! The idea that you can is absurd. You could take his license plate number down and make/model of car and notify the State/Local Police who have the legal standing you clearly lack to pull over and issue a citation to a speeding driver.

2) You’re in the local grocery store and you “think” you witnessed a couple of kids stealing a few candy bars. You can’t arrest and then personally charge the kids for larceny or theft in court.  The idea that you could do this is absurd. You can call the local police who have the legal standing to arrest the kids and then the local District/County Attorney can opt to prosecute the kids – or not based on the evidence at hand – in court for “theft” or “larceny” but you and I? We can’t do this!

3) You are an individual/competing supplement company and you see a new product in the local supplement store. You grab the bottle and you turn to the Supplement Facts panel to see an ingredient listed you have never heard of nor seen anywhere before. You genuinely believe this ingredient cannot be compliant with DSHEA. I’m pretty sure based solely on that argument alone you can’t file a Complaint in court and that such a Complaint is defective. What you can do is alert the FDA or other regulatory agency with jurisdiction over such matters. It is up that agency to pursue and investigate or not to. Not you. The idea that you can do this is to me, somewhat akin to vigilantism. And we do not allow nor condone “vigilante justice” in the USA!

There is another “defect” in the Complaint in my opinion regarding how it reads as filed. In my layman’s opinion, this Complaint “Fails to State a Claim.”  What does that mean you ask?

Within a judicial forum, the failure to present sufficient facts which, if taken as true, would indicate that any violation of law occurred or that the claimant is entitled to a legal remedy.

There are no facts written into the Complaint that I am aware of. On Line 9, Page 4 there is some vague and obtuse verbiage that reads “On information and belief, the Defendant has intentionally manufactured a product so it contains amphetamine…” this is as close to a “real Claim” in the Complaint that I can see. This still probably does not reach the level of “fact” and is however, simple enough to resolve anyhow. The Plaintiff better show up in court with a bona fide laboratory assay conducted on the contents of a sealed can of Driven Sports Craze purchased within the State of California or delivered to the State of California whereby proper chain of custody of the can has been documented and followed and the contents of the can demonstrated to contain amphetamine by a validated laboratory assay conducted by a properly accredited laboratory. And by “amphetamine” I refer to the chemical moieties with a CAS registry number of either 300-62-9 or the right handed (CAS# 51-64-9) or left handed isomers (CAS# 156-34-3) singularly or in some combination thereof. I do not believe that there are any “facts” presented in the Complaint that read on Craze containing amphetamine. Just “on information and belief.” Well “on information and belief” I state that the moon is made of cheese! So there! See what I mean?

If this were me litigating this Complaint in some alternate dimension and universe, my Complaint would have absolutely read on something akin to, “On such and such date, a bottle of Craze bearing lot #ʼs 123 with an expiry date of XX/YY/ZZ was obtained from Store X in City Y in the State of California by so and so and was sent to Laboratory Z for analytical testing. The Director of the Laboratory has declared under Oath and pain of perjury that the bottle of Craze received was intact and not tampered with to his knowledge.  Laboratory Z is a fully accredited analytical laboratory that is routinely used to conduct forensic and drug testing by The State of California. Under testing methodology “A” the laboratory determined that per each serving of Craze, Xmgʼs of amphetamine were detected. Attached herein in Appendix A are the Adjurated Declaration of the Laboratory Director regarding the Chain of Custody and condition of the bottle of Craze as well as an official laboratory report showing the presence of Xmgʼs of amphetamine per serving.”

There just does not seem to be any “fact” or “evidence” whatsoever to support that Craze contains amphetamine in the Complaint.  Just “information and belief” or in other words, “somebody told me they think there might be amphetamines in that there Craze product!” Well? Then again there might not! So why is no evidence of analytical testing noted and why weren’t the results of such tests presented in the Complaint?  Even if you do not want to reveal your entire hand, a Plaintiff’s attorney could have easily written in to the Complaint, “We have independent, analytical evidence that Craze contains, amphetamine, a dangerous substance that is a Controlled Drug in the State of California that we will show at trial.” But we do not read anything remotely like that now do we?

All of the allegations written under Section 8 of the Complaint are just that – allegations that I feel are not substantiated with any evidence to back them up.  Just the assertion by Plaintiff’s counsel that the ingredients are not compliant with DSHEA – something I am not quite sure they legally have cause to make - unless some regulatory body with proper legal standing makes such Claims or if Matt Cahill somehow suffers some traumatic brain injury between now and his initial hearing date and then blurts out in open court, “Yes, I say yes, I admit it, you got me! Them there ingredients are not, I say, them there ingredients are absolutely not compliant, no sir, not DSHEA compliant at all.” And the moon is indeed made of cheese too.

There is another issue at hand too. The Complaint relies heavily on the FDAʼs Draft Guidance on NDI Notifications which should not be allowed. A recent court case (federal) in Florida casts doubt on the FDAʼs ability to rely on Draft Guidance Documents in enforcing policy. See United States v. Franckʼs Lab, Inc. In this case the court found that “…FDA could not use a guidance document to upset industry expectations that it helped to create “without explanation.”

While the Franckʼs case does not directly involve dietary ingredients or supplements, its implications extend deeply into other areas of FDA law, specifically as it relates to the FDAʼs increasing use of draft guidance/guidance documents to expand regulatory requirements. In the past year or so, the FDA has issued dozens of such draft guidance documents and final guidance documents, while on the other hand releasing very few significant regulations. Since it appears the FDA prefers to dictate guidance documents instead of proceeding through public notice and comment rulemaking, the court’s decision in Franckʼs could have profound and wide applicability regarding the FDAʼs ability to regulate or enforce its laws via dictated guidance documents instead of rules. Indeed, many times the FDA has applied draft guidance documents as if they represented binding legal obligations. In the situation we are in, the FDA has publicized the contents of the document in communications with our industry even before the document has been finalized. The FDAʼs attempt to regulate and enforce federal law through self-affirmed guidance documents often imposes new obligations on  regulated industries like ours. Federal courts have long recognized that an agency policy creating duties requires notice and comment rulemaking. See Community Nutrition Institute v. Young, 818 F.2d 943, 946 (D.C. Cir. 1987); American Hospital, 834 F.2d 1037 (D.C. Cir 1987); Syncor Intʼl Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 1997).

A recurring criticism of FDA is its use of guidance documents instead of rulemaking; thus the FDA fails to “attempt [] to test its views” through the more rigorous rulemaking process. See Franckʼs Lab at 74.

All this does not mean Driven Sports is “off the hook” here. While I would like to see a judge throw out the case totally, more than likely – and especially in California which desperately needs tort reform to prevent what I consider to be habitual and abusive litigation – the judge will likely grant the Petitioner leave to amend the Complaint realizing the technical defects I have discussed (and probably a lot more I have not) and give the Petitioner a second bite at the apple. If the second time around the Plaintiff’s cause to action is no better than what we see here I would expect to see this Summarily Dismissed.

No matter what the outcome this is going to cost Matt Cahill and Driven Sports a fair amount of money. Class action defense attorneys typically charge $500-$1000/hour (good gig if you can get the work, eh?) and I am guessing this little debacle will run Driven Sports something in the neighborhood of $50,000-$100,000 right off the rip.  More if the case is allowed to go forward. Likely, the Plaintiff’s will push for a settlement and then Matt has to make a choice – and pick what will be the lesser of two evils.

1) Does Matt Cahill seek a Summary Dismissal and barring receiving such; fight this case to the bitter end?  Does Drive Sports risk something unexpected coming up like a laboratory assay that demonstrates one or more ingredients – none of which are amphetamine - being found in Craze but not listed as such on the label? This may risk the ire of an angry jury who will then find Matt/Driven Sports “guilty of something” and penalize them monster dollars…not to mention that he can and will then likely be “class acted upon” and sued in the 49 other states after that for the same issue or;

2) Does Matt sit down at a table with what are basically a bunch of shakedown artists and agree to some monetary settlement where he admits no guilt but pays the “injured class” (and a group of tort attorneys) something like a million bucks to make this all go away?

Again, I am not an attorney and am not qualified to give legal advice. This article is an exercise in me just “thinking out loud.”  Nothing more.  However, if the allegations made in the Complaint as it stands now are allowed to move forward “as is” I will be very concerned and so should all of you. Because this will mean that anytime anyone decides, “I do not think that ingredient in their product is DSHEA compliant…”, a precedent will have been set to allow individuals and companies to make such challenges in open court using “draft guidance documents” as iron-clad rule. The Petitioner need no evidence other than “I think it adulterated/misbranded” and with that, I suspect you will see a serious clogging of the judicial system with frivolous, meritless cases that end up diminishing consumer choice and driving up the costs of those supplements still available for sale (who do you think is going to end up paying for these court costs?).