Three times in the past six months, the Food and Drug Administration (FDA) has announced alerts about the illegal and possibly dangerous addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements.

As of early April, the FDA had identified 72 weight loss products that illegally contain at least one active prescription drug. At least one of nine different prescription drugs (see Table 1) had been added to each of these products, including four drugs not approved by the FDA for sale in the U.S., even as prescription drugs.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges. Thus far, the FDA’s response has also been inadequate.

Lack of regulation has dangerous consequences

You may be interested in knowing how these products could slip past the notice of the FDA in the first place.

Prior to 1994, dietary supplements were not regulated; one particularly bad outbreak of illness associated with the dietary supplement L-tryptophan led the FDA to attempt to obtain the legal means to reduce misleading promotional claims being made for these products and to develop standards for Good Manufacturing Practices (GMPs).

Instead, the 1994 Dietary Supplement Health and Education Act (DSHEA) clarified that dietary supplements were to be regulated essentially as foods, not drugs, and thus were exempt from the tougher FDA regulation accorded to drugs. In particular, there is no requirement for companies to register all their products with the government. The FDA took over a decade to promulgate regulations describing GMPs for dietary supplements and, as of now, they have still not taken effect for many companies, especially small ones. As a result, for many products there is still no regulation ensuring that the amount of a substance claimed to be in a supplement is actually present, or that contaminants or active drugs are not present.

In addition, the FDA cannot require manufacturers of naturally derived dietary supplements to provide proof of either effectiveness or safety. In the rare (and usually government-funded) rigorous clinical studies that have compared dietary supplements’ effectiveness to a placebo, the majority of dietary supplements have been found to be ineffective.

But some dietary supplement manufacturers seek to gain a competitive advantage by illegally adding prescription drugs –- which are too dangerous to be sold or used without a physician’s approval. This converts the products from dietary supplements into prescription drugs. To sell these without FDA approval is illegal.

For example, powerful diuretics, intended to help people lose water, may be added to the supplements. The diuretics could cause harm if used without medical supervision.

Other drugs that are fraudulently added to these weight loss supplements include amphetamine-like drugs; an antidepressant; an anti-obesity drug rejected by the FDA because it increased suicidal thoughts in users; an anticonvulsant; and a formerly-approved laxative suspected of causing cancer.

According to the FDA, "The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke."

Many of the products were found to contain sibutramine, a controlled substance, at "levels much higher than the maximum daily dosage for MERIDIA, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks."

Table 1. Nine Illegally Added Prescription Drugs

Another controlled substance, Fenproporex, was found in the products, which "can cause arrhythmia and possible sudden death."

About the contaminated products, the FDA said:

These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages.

The tainted products, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be "natural" or to contain only "herbal" ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the undeclared active pharmaceutical ingredients listed in Table 1.

What You Can Do

If you have used any products containing these ingredients, you should stop taking them and consult your health care professional immediately. In addition, we encourage consumers to seek guidance from a health care professional before purchasing any weight-loss products.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to:

MedWatch
5600 Fishers Lane
Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088