More About FDA Recalls

NOTE: A reader who is a physician-scientist with experience in the biopharmaeutical field has sent in the below information on FDA recalls in response to our post from a couple weeks ago, FDA Warns About Hair Loss from Total Body Mega Formula. Though not totally hair loss related, I think many people will still find it quite interesting. Again, this post (below the line) was not written by myself or any of the other BaldingBlog editors, but it provides some very useful information and was written by a reader that has provided some excellent emails in the past.

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Prior posts suggest that readers wonder about how the FDA can recall products (such as natural substances), which they have no regulatory authority to approve for marketing. “Natural substances”, while not requiring approval by regulatory agencies, can be unsafe as well as ineffective. Thus, the FDA has oversight in some instances when the safety issues (and not effectiveness) become significant for public health. As a result, the FDA does have the capacity to recall or ban a substance from the market, when a request for voluntary recall by the manufacturer is thought to be insufficient or ineffective.

When physicians or other health professionals notify the FDA of serious adverse events associated with these products (and thought by the FDA to be causally related), and where the risk/benefit ratio is believed to be negative, the FDA asks the firm to remove the dangerous product voluntarily from the market (i.e., without FDA’s written request). In rare cases, if the firm does not recall the product, the FDA can seek legal action under the Federal Food Drug & Cosmetic Act. These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product. Any recall may also involve approved drugs in addition to unapproved (natural) substances. In addition, in serious cases requiring immediate action, the FDA may also rule that the substance should be banned and work to enforce both a voluntary and mandatory recall. As part of this effort, the Agency also usually issues a public warning via the news media to alert as many consumers as possible to the potential hazard.

For recalls, which your reader was interested in, three types exist:

1. Class I recalls are for dangerous or defective products, whether approved or unapproved, that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
2. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.
3. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.

The most important message about natural substances and other mixtures is “buyers beware.” Because these drugs/substances do not go through a regulatory approval process before their marketing, the exact composition, effectiveness, and safety is undefined. When health professions report adverse events that greatly impact the safety of the drug and a hazard is identified, the FDA often works quickly with the vendor to propose a voluntary recall and, if not done, take stronger action.

An example of the FDA’s approach to an unsafe natural substance occurred in 2003. Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is the potent chemical ephedrine, which when chemically synthesized is regulated as a drug. Before 2003, ephedra products were extensively promoted in drugstores (over-the-counter), convenience stores, gas stations (by the counter), and the internet to aid weight loss, enhance sports performance, and increase energy. In 2003, the FDA issued a consumer alert on the safety of dietary supplements containing ephedra as the result of cardiovascular-related deaths in some high school and college athletes taking this substance for performance enhancement. The alert advised consumers to immediately stop buying and using ephedra products. The FDA also notified manufacturers that dietary supplements containing ephedrine alkaloids present an u nreasonable risk of illness or injury, and that these substances would be banned. Ephedra-based products are not currently sold over-the-counter.