Trade Organization Overload?

By James J. Gormley

The above headline comes from the provocative question I was asked for this article: Are there too many trade associations?

“The question is not whether we have too many trade associations, or not enough, but whether they are getting the job done,” notes Jarrow Rogovin, founder and president of Los Angeles, CA-based Jarrow Formulas.

Rogovin, who might be regarded as a one-man trade association himself, has a point. Every trade association has its strong suits and its specialties, and so, once again, the answer to the ultimate existential question, “Who am I?,” should serve as a signpost as to which organization might be best suited to your company’s needs.

If you are heavily involved in herbals, AHPA might be the right organization for you; if OTCs are your bailiwick, then CHPA is the right group for your firm.

On the other hand, if you make or sell a variety of products, CRN, NPA or UNPA might be well suited for you, and if you want to reach retailers as well, that’s where NPA comes in again.

There are also associations that specialize in certain categories, such as GOED and the IPA.

Keep in mind, however, that you can join more than one association, and probably should consider doing so if your company is able, since in that way you maximize your firm’s chances of being on the front lines of promoting and defending the natural products industry, whoever is leading the charge.

Also remember that the most strategically minded trade associations are able to forge powerful collaborations with credible consumer groups on important or watershed issues.

A perfect, recent, example of this was the coalition of all of the natural products trade groups, plus consumer organization Citizens for Health, which together successfully campaigned for the passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the AER Bill) in June 2006.

Another, more recent, example is Citizens for Health’s push in support of AHPA’s KeepSupplementsClean.org initiative.

There are other credible consumer organizations out there too, including, but not limited to, the Alliance for Natural Health (ANH), the National Health Federation (NHF), and Your Voice for Health (YVH).

Get these questions answered before you join any trade organization:

1. Is this organization mainly focused on my channel of trade or type of business?
2. Does the organization have a “1 member, 1 vote” policy for full members (it should)?
3. Is the work the organization does focused on rubber-hits-the-road areas I want it to focus on?
4. Is the organization more concerned about “having a seat at the table” than shaking up regulators and Congress?
5. Does the organization provide ample opportunities for all voting members to serve on the board and committees?
6. Is the organization respected and feared on Capitol Hill and in College Park, MD? (The first is great, but the latter is even better!)
7. Does the organization plan to collaborate more with credible consumer organizations so that we, as an industry, can present a united front, one that cannot be dismissed as “industry only”?

And depending on how satisfied you are with the answers you get, along with recommendations from colleagues who are already members, you will be able to choose wisely.

A Trade Associations Primer

• AHPA (American Herbal Products Association) is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products.
• CHPA (Consumer Healthcare Products Association) represents more than 75 manufacturer member companies and 150 associate member companies. Manufacturer members manufacture or market OTC medicines and dietary supplements, including contract and private label manufacturers.
• CRN (Council for Responsible Nutrition): a Washington, D.C.-based trade association representing 100+ dietary supplement manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers.
• GOED (Global Organization for EPA and DHA Omega-3s) is a trade association whose goals are to increase consumption of omega-3s to adequate levels around the world and to ensure that the industry is producing quality omega-3 products that consumers can trust.
• IPA (International Probiotics Association) is an international organization with members equally divided between industry and academia and its goal is to provide a unique forum for the exchange of research and the latest breakthroughs in probiotic technology and new product development.
• NPA (Natural Products Association): NPA is the largest and oldest organization representing the entire natural products industry, with more than 2,000 members in all 50 states and internationally, accounting for over 10,000 retail, manufacturing, wholesale, and distribution locations of natural products.
• UNPA (United Natural Products Alliance ) is an association representing many leading dietary supplement, functional food, natural products and analytical and technology companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability.
  
  [Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
  

10,000 Signatures in 10 Days; We Can Do It!

By James J. Gormley
With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.

To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!
Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!

Petition to Demand that the FDA Withdraws the NDI Draft Guidance!

By James J. Gormley

Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

That's why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

"I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."

Will you sign this petition? Please click here.

Thanks!

Orrin Hatch Letter to John McCain About S. 3002

This letter was sent by Senator Orrin Hatch, senior member of the HELP committee, to Senator John McCain on March 4, 2010, in large part as a result of the massively successful letter-writing campaign initiated by Citizens for Health and several other groups.
Please click here.

9 Reasons S. 3002 Has to Go

By James J. Gormley
http://www.citizens.org/?p=1965
1. No phase-in period or “effective date”. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.
2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities” under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.

3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.

4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients” and “labeling.” As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.

5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,” the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.

6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.

7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.

8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.

9. FDA recall and “cease distribution” authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution” order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.

Anti-Supplement “Perfect” Storm Building in Washington

By James J. Gormley
http://www.citizens.org/?p=1924

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trust has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.”
Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores.

NPA Alerts Health-Food Stores to Dangers of S. 3002

http://thegormleyfiles.blogspot.com/2010/02/npa-alerts-health-food-stores-to.html
According to the Natural Products Association (NPA) in an e-mail alert issued today, here is how S. 3002 would affect health-food stores:
All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.

For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.

Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.

Act now!

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.

Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine or pseudoephedrine and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids
Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, 'roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called "pyramiding." With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

Legislation and Enforcement
On March 16th 2004, Joseph Rannazzisi, then deputy director of the DEA's Office of Diversion Control, said in testimony before the House Subcommittee on Crime, Terrorism and Homeland Security:

"The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically or pharmacologically related to testosterone. Because DEA’s authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction. H.R. 3866 [The Anabolic Steroid Control Act of 2004 ] will correct this problem."

Well, the Anabolic Steroid Control Act passed in October 2004.

On the bill's passage, one of its sponsors, Sen. Orrin Hatch (R-UT), remarked:

"Under this bill, clever chemists will no longer be able to dodge the law by disguising their chemicals to skirt the legal definition of a steroid. Our bill gives the Drug Enforcement Agency the power to schedule nearly any steroid precursor now or in the future--giving the law flexibility we don't have to play catch-up with every new andro look-alike that comes along."

On September 29, 2009, the DEA's Rannazzsi, now deputy assistant administrator, said this in testimony before the Subcommittee on Crime and Drugs:

"Although DEA does not have the authority to enforce DSHEA [the Dietary Supplement Health and Education Act of 1994], DEA does have statutory authority to investigate incidents involving the illegal manufacture and distribution of anabolic adrenergic steroids in the dietary supplement market. [...] DEA has the authority and responsibility to investigate companies that are marketing products as dietary supplements that are adulterated with controlled substances."

As well the DEA should; if yogurt were suddenly used as a delivery vehicle for sports steroids, would our guardians of public health call for a new law restricting access to yogurt or would increased enforcement and enforcement funding be directed to the DEA to get the job done? The latter, I would think.

If supplements are being adulterated by illegal labs, why then should supplements get a bad rap? Steroids and sports doping is all about unethical pharmacies and illegal labs.

Case in point, in January 2009, a 198-count DEA indictment was unsealed charging 12 pharmacists and pharmacy owners with participating in a conspiracy that dispensed and sold thousands of dosages of anabolic steroids, including powerful veterinary steroids approved for animal use only.

Another case in point: in October 2009 the DEA announced the completion of a 10-month undercover investigation into an illegal anabolic steroid manufacturing ring that led to three arrests. In the raid, agents seized over 500 vials and 1,850 capsules of anabolic steroid pills.

While the U.S. Food and Drug Administration (FDA) has been involved in sweeps relating to the illegal sale of unapproved or misbranded drugs, such as the recent Internet sweep in November 2009 called the "International Internet Week of Action," many observers, including this commentator, strongly believe that all investigation and enforcement of sports doping and illegal steroid distribution and use should immediately be more clearly placed under the aegis of the DEA, as sports doping is not a problem of food products (such as supplements) but a problem of drugs---a problem of dope, pure and simple.

The Dietary Supplement Excuse

[With the DSSA bill, S. 3002, now up for vigorous debate, it's worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

By James J. Gormley

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

In the midst of all of this, in February 2003, Baltimore Orioles’ pitcher, Steve Bechler, died due to “a constellation of risk factors,” according to Broward County medical examiner, Dr. Joshua Perper, including: “being significantly overweight and not well conditioned”; “not yet being acclimatized to the warm climate of Florida” and “having hypertension and abnormal liver function.”

These extremely important facts were not mentioned at the time by Rep. Henry Waxman (D-CA) when he used this case as leverage for his anti-supplement intifada now, were they? In fact, according to April 2003 comments by attorneys Marc Ullman and Seth Flaum that were submitted to the FDA regarding the agency’s proposed rule for dietary supplements containing ephedra alkaloids:

“This information was left out of many of the news reports that followed Mr. Bechler’s death and has never been acknowledged by any FDA official.”

Picking up the doping follies again in December 2004, grand jury testimony appeared in the San Francisco Chronicle in which the paper said Bonds “admitted to unknowingly using steroids during the 2003 season. In July 2005, Conte pled guilty to steroid distribution and money laundering. Reports emerged in January 2007, said USA Today, that Bonds tested positive for amphetamines during the 2006 season.

"Oh, Those Tainted Dietary Supplements" or The Dietary Supplement Excuse
Which brings us back to the present, where we apparently have entered a new age, the age of "The Tainted Dietary Supplement Excuse," an excuse that almost anyone now who is caught improperly using spiked products cooked up in some lab can apparently take advantage of.

Many of these product abusers would have us believe that they are hapless fools, doe-eyed innocent pawns of diabolical masterminds who nefariously sabotage the benign nutritional products that are foisted upon them. Hardly.

Maybe we should suggest that users of heroin could claim that they used an opium poppy extract unknowingly tainted with morphine?

Perhaps people busted for cocaine possession could claim that the Erythroxylon shrub extract they were taking was tainted with cocaine alkaloids?

Who cares about athletes exercising personal responsibility and playing by the rules when stadiums are packed to the rafters and team (or even national) glory is at stake? Isn’t it that much easier for coaches or commissioners to look the other way when championship rings or gold medals are being handed out?

It’s not about dietary supplements but about greed, money, politics and power. The pharmaceutical lobby is very powerful. The money at stake behind sports is staggering. Our need for sports heroes is also very compelling.

America needs a scapegoat. How convenient that dietary supplements continue to be easy targets. Why don’t we blame pharmaceuticals? At least, we know they harm and kill people in droves.

Oh right—sorry. Forgot about all the pharma ads in newspapers, magazines and TV and their stranglehold on Congress and the FDA.

We’ll have to come up with another idea.