We are not sure of the reason, but it seems that every three months or so, a national media outlet weighs in on an old story: tainted nutritional supplements. To be sure, the story will not go away in the sports world. Athletes who test positive for steroids often say they thought they were taking vitamins.

The dietary dangers faced by professional players is a good launching point for a substantive news story. If the pros can be victims, what about the amateurs playing high school and college sports? What are the players’ coaches doing about the dangers of contaminated supplements? Are industry forces and organized sports working together to eliminate the problem? If not, why not?

No, we get a rehash of anecdotes with the same question: Are vitamins safe? So goes the Sept. 7 article in the Wall Street Journal headlined, “What’s Really in Supplements?” with the ominous sub-headline, “Regulators and Physicians Raise Alarms About Dangerous Ingredients in Many Herbal Remedies.” The illustration is scarier; it features demons escaping an opened capsule.

Among the article’s weaknesses:

• No one at the FDA raises an alarm. One FDA official says consumers should read labels and another says that the agency is doing the best it can to find and ban bad products.
• Just a few — not the headlined many — herbal remedies are cited as causing problems. The article reaches back five years to a now-banned substance as an example. Why bring up ephedra if product integrity is an issue today?
• No event gives the article urgency. No one famous has become ill or died from taking a supplement. The most notable recalled product of recent times is Hydroxycut, which gets no mention. The article says that the  FDA will hold hearings this month without giving specifics.
• The reader service is laudable, but not prominent enough. The first mention of information sources about supplements appears in the fifth paragraph, after the anecdotal lead about a policeman who unwittingly took steroids.
• Statistical evidence of the prevalence of product contamination devolves into a he-said, she-said between HFL Sports Science and the Council for Responsible Nutrition.

After all of that, the Journal article treads on much of the same ground covered in a May 18 Sports Illustrated article that also fed on fear with the headline, “What you don’t know might kill you.” Where is the news?

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The Tenth Circuit’s decision reversed the Utah District Court and held that the FDA’s ban on low dose ephedra was not arbitrary or capricious.

According to counsel for Nutraceutical, Emord & Associates, P.C.,

the petition faults the panel for imposing “the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved by statute for pre-market review of drugs,” explaining that the “decision’s impact extends far beyond a ban on EDS” by granting “FDA authority to declare any dietary ingredient adulterated on FDA’s subjective assessment of the adequacy of the ingredient’s health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose).” The petition faults the panel for interpreting the Food Adulteration provision of the Act to be internally inconsistent and irrational: “FDA’s Rule produces the absurd result of causing raw crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule but legal when placed in a tea bag.”

The petition explains that, in context, the statutory term “unreasonable risk” is defined as that dose level that causes illness or injury and above. The statutory term “significant,” by contrast, “describes the degree of illness or injury incurred (e.g., a tumor as opposed to a headache).”

To read the petition for rehearing, click here.

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Next stop, Supreme Court?

Neutraceutical Corp. v. Von Eschenbach, No. 05-4151 (Aug. 17, 2006)

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The results?

Forty-one women completed the study. The treatment group lost significantly more body weight (-7.18 kg) and body fat (-5.33 kg) than the control group (-2.25 and -0.99 kg, respectively), and showed significant declines in heart rate, serum cholesterol, triglycerides, cholesterol to high-density lipoprotein ratio, glucose, fasting insulin, and leptin. Blood pressure, electrocardiograms, other clinical chemistry measures, blood histology, urinalysis, and self-reported physical activity were similar in the groups. Minor symptoms included dry mouth, insomnia, nervousness and palpitations. The treatment group reported more energy and decreased appetite compared to controls and scored higher on a quality of life domain assessing vitality.

Conclusion: A dietary supplement containing a low potency ephedra/caffeine mixture appeared safe and effective in causing loss of weight and body fat, and improving several metabolic parameters, including insulin sensitivity and lipid profiles when tested under physician supervision. Such supplements could be a useful tool to assist with weight loss.

Meanwhile, the “ephedra-free” supplements that have replaced ephedra on store shelves are increasingly coming under attack. In a study entitled “Hemodynamic effects of ephedra-free weight-loss supplements in humans,” published in the American Journal of Medicine, several of the researchers who lead the charge against ephedra the first time around conclude that “ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra.”

Thanks to David for the tip!

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About $4.7 million of the San Diego-based company’s insurance coverage would pay the claims if approved by a U.S. Bankruptcy Court judge. To read the article, click here.

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We previously mentioned Hi-Tech in connection with a trade dress dispute here. This time, FDA has gone after what it describes as $3M in product marketed under the brand names “Lipodrene,” “Stimerex-ES,” and “Betadrene.”

The FDA press release also notes the following at the bottom:

Hi-Tech has previously filed a lawsuit against FDA seeking to prevent the agency from enforcing the 2004 rule declaring dietary supplements containing ephedrine alkaloids to be adulterated. The United States recently moved to dismiss that lawsuit, which is currently pending in the United States District Court for the Northern District of Georgia.

The complaint in Hi-Tech v. Crawford, posted here, makes for an interesting read, and way too much to comment on in this short blog posting. Essentially, Hi-Tech is asking the court to apply the decision of the Utah District Court in Nutraceutical Corp. v. Crawford to all products containing ephedra.

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Ephedra

In this press release, the FDA reports that at its request the U.S. Marshals seized five unlabeled boxes containing various quantities of Lipodrene bottles from ATF Fitness Products, Inc. in Oakmont, PA. Each bottle of Lipodrene contains 100 tablets and is labeled with the recommended daily dose of 50 mg of ephedrine alkaloids. The seized products are valued at approximately $16,000. U.S. Attorney’s Office for the Western District of Pennsylvania filed a Complaint for Forfeiture against the Lipodrene supplement.

Health Supplement Retailer reports that ATF markets its Sci-Fit Nutrition and Nature’s Science lines via its online Web site at www.scifitauthentic.com and various online supplement retailers.

Brazilian Diet Pills

Better late than never, FDA has issued this warning to consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury. We reported on this story when it appeared 3 months ago.

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According to this press release Emord’s program will document

instances of FDA and FTC abuse of power that sacrifice life or liberty. He will interview experts in the fields of health and medicine, litigants in cases against the FDA and the FTC, members of Congress and other government decisionmakers, and victims of FDA denial of access to medical treatment or health information. He will also provide his own expert commentary on the legal and health implications of the government’s actions. “We will reveal the cost in human life, health, and liberty of political decisions that protect drug companies from competition at the expense of consumers,” Emord said. “We will show how FDA and FTC fail to follow the rule of law, harm those they were designed to help, and ignore the will of Congress, the Courts, and the American people,” he said.

The inaugural January 14 program will discuss the FDA’s ban on ephedra, the agency’s unlawful maintenance of that ban in the face of a federal court order holding the ban unlawful, the scientific evidence on the safety and efficacy of low dose ephedra, and the effect on obesity in consumers denied access to the product for weight loss. Featured guests include Arne Astrup, M.D.; scientists Durk Pearson and Sandy Shaw; and the President of Nutraceutical Corporation (the party that won the ephedra case) Bruce Hough. Emord is the lead counsel for Nutraceutical Corporation in the case.

Thanks to Greg for the tip .

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Was the ban on ephedra overturned?

No. The ban on ephedra products of more than 10 milligrams per
dose is still in effect. The ruling only invalidated the ban on
ephedra products with 10 milligrams or less of ephedrine
alkaloids and with important restrictions, as indicated below.

Can retailers and manufacturers begin selling ephedra products
again?

*The decision only applies to ephedra products with 10
milligrams or less and only within Utah’s Central Division
district court jurisdiction. FDA may challenge sales outside of
that jurisdiction.

*Only in single and daily doses of 10 milligrams or less.

*Only in states that have not prohibited or restricted sale of
ephedra.

What are the risks of selling ephedra?

*Enforcement action. Those retailers or manufacturers selling
ephedra product in any federal court district other than Utah’s
Central Division can still be subject of enforcement action by
FDA. In fact, in early December FDA seized dietary supplement
products containing ephedra in Texas and Florida. An FDA
spokesperson was quoted by the Associated Press as saying that
the agency interprets the court ruling as only applying to the
company involved in the case to sell ephedra products at the
lower dosages. To view the FDA press release, go to
www.fda.gov/bbs/topics/NEWS/2005/NEW01267.html

* Ruling reversal. FDA has appealed the ruling. Should the
ruling be overturned, the ban on all ephedra products regardless
of dosage and where they are sold or manufactured will remain in
force.

* Liability. Earlier this year NNFA understood that insurance
for ephedra products was not being underwritten. If this is
still the case, it means full exposure financially in the event
of a civil lawsuit. To date, there have been numerous lawsuits
regarding the use of ephedra products for damages in the
millions of dollars.

* Availability. While the ban on ephedra products of 10
milligrams or less sold in the US has been lifted
with important restrictions an embargo on imports remains in
effect. This means that foreign shipments of ephedra product to
the US can be turned away at the point of entry.

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