Those of you that regularly read this website know that I am not a fan of the supplement industry or reference to things outside of the mainstream as "alternative" therapies. My opinion is that there should be therapies that are proven to work, those that do not work, and those that we don't know about yet. The shady part of this industry has gotten bolder and bolder regarding the outrageous health claims, so I am pretty happy that the FTC and FDA has initiated a number of enforcement actions.

Why do I care so much about this? The thought of people suffering and dying because they believe these claims and not seeking conventional treatment makes me pretty upset...

There is a new Sheriff in town...

What is driving part of this is the new head of the FDA, Mark McClellan and Howard Beales, Director of the FTC's Bureau of Consumer Protection who are both involved in Operation Cure.All.

Word is that McClellan is really shaking things up at the FDA after only eight months in office. He has instituted new changes such as speeding up approvals by reviewing parts of NDAs (new drug applications) as they are submitted to red flag issues early and trimming of multiple reviews. Drug companies have been asking for these kind of changes for some time. Also a sign of change is the announcement that NCI and the FDA will collaboration to increase the efficiency of cancer drug approvals.

No patsy to the drug lobby, he has also instituted some changes that are obviously not in the favor of big pharma. Limiting the extensions on patents that delay introduction of generics and forcing companies to report errors involving their drugs to the FDA within 15 days are two proposals which are not making any pharma CEO happy.

In a bit of a split decision, the FDA is rumored to be giving more leeway on health claims for foods but also making them put more nutritional data on labels (hopefully trans fatty acid content). I think this is a pretty bad idea, since health claims could then be made for foods without wide scientific agreement. Also, the recent crackdown on the supplement industry is certainly a welcome sign that the FTC and FDA will not sit by while unproven claims are made.

Coral Calcium

June 10 - The FTC charges the marketers of Coral Calcium Supreme with "making false and unsubstantiated claims about the product's health benefits." The charges where "claiming, falsely and without substantiation, that Coral Calcium Supreme can treat or cure cancer and other diseases, such as multiple sclerosis and heart disease. The FTC charges that these and other claims go far beyond existing scientific evidence regarding the recognized health benefits of calcium."

SeaSilver

June 19 - The FTC charged "false and unsubstantiated claims about the health benefits and safety of a product they market called "Seasilver"- a purported cure-all liquid supplement. The FTC alleges that the defendants promoted Seasilver as safe and effective to treat or cure 650 diseases, including AIDS and cancers, and to cause substantial and permanent weight loss." In this enforcement action US Marshals seized over 130,000 bottles of Seasilver worth of $5 million dollars. The federal court earlier froze the assets of the defendants and the FTC is "seeking preliminary and permanent injunctive relief, including restitution to consumers who purchased the product." If the lawsuit is successful, anyone who purchased the products under the belief of false claims could get thier money refunded (or some portion of it).

Also noted in the FTC press release was the fact that Seasilver had been cited for manufacturing facility violations. This included allowing production line employees to work in street clothes!!! Hardly sounds like GMP to me...

Natural Herbs and Supplements my Cialis

June 20 - The FDA issues a warning to consumers that the following products: SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin manufactured by NVE, Inc., in Newton, N.J. and distributed by Hi-Tech in Norcross, Ga were found to contain the Eli Lilly/ICOS drug Cialis. These products were being marketed as dietary supplements and were being sold over-the-counter claiming to increase stamina, confidence and performance. Cialis is approved in Europe for the treatment of erectile dysfunction and is pending approval in the United States.

An interaction between certain prescription drugs containing nitrates and the active ingredient Cialis may cause a drastic lowering of blood pressure. Erectile dysfunction is often a common problem in people with diabetes, hypertension (high blood pressure), hyperlipidemia (high cholesterol), ischemic heart disease (nitrates are involved in treatment of these diseases).

Below are the FDA and FTC Tips for Consumers

The FTC, the FDA, and other sister agencies have compiled a list of valuable and reliable sources of health information for consumers. The FTC Web site at www.ftc.gov/cureall, and the FDA Web site at www.fda.gov, provides direct links to these sources of information. Consumers are encouraged to visit these Web sites when searching for health information and ask the following questions before deciding whether to purchase a health-related product:

• What is the product?
• What is the evidence that this product will do whatever the product purports to do (e.g., counteract the disease or medical condition being relieved; lead to better results than conventional treatment?)
• Have results from studies of this product been published in any peer-reviewed medical journals? Can I have copies of the publications or references to these publications?
• What are the training and credentials of the provider?
• Is the provider willing to communicate with my primary care physician and/or my health insurance company?

Websites of interest

FTC press release on Coral Calcium action: http://www.ftc.gov/opa/2003/06/trudeau.htm

FTC press release on SeaSilver action: http://www.ftc.gov/opa/2003/06/seasilver.shtm

NOTE: The Commission authorizes the filing of a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant actually has violated the law. The case will be decided by the court.