Medical Library

“Cleaning Up” Alternative Medicine: Will New FDA Regulations Solve the Purity Problem?

by Steven Brown, M.D., Ph.D.
© 2008

Turn on the television, and before long, a legal advertisement will grab your attention.

“If you or someone you love has taken xyz drug, call the number on the screen today!”

While we all worry about the dangers of prescription drugs, we do not worry about their purity. Even the most skeptical lawyer knows that prescription drugs in this country contain what the label says. Unfortunately, alternative medicine is a different story. Researchers have been finding dangerous impurities in alternative medicines for the past decade. Although many in the public do not know about this issue, the rule for these products has been “let the buyer beware.” A new FDA regulation attempts to correct the problem. Will it succeed?

Studies on both coasts have documented the problem. A 1998 study in California found that one third of traditional Asian medicines tested contained impurities, including poisonous metals, hormones, Viagra, and diabetes medicines.i In Boston, 20% of herbal preparations tested contained dangerous levels of lead, mercury, and arsenic.ii

As the California study demonstrated, impurities are not always accidental by-products of the manufacturing process. Unscrupulous producers deliberately add conventional drugs to their pills. In July 2006, the FDA issued a warning that seven different supplements sold for “sexual enhancement” contained Viagra-like drugs.iii Having more satisfied customers is good for sales. Unfortunately, those customers think they are responding to a “natural herb.” No one discloses the risks. No one explains the potential for interaction with other medicines.

To you and me, these “nutritional supplements” look like pills. But the government regards them as food, and has done so for decades. In 1994, the law changed, and “supplement” became a legal term. Essentially, supplements are a sub-category of food with additional legal protections. Since 1994, the regulation of food additives has been tougher than the regulation of supplements.iv

The inconsistency of this approach becomes obvious when we consider the manufacturing process. Take the example of digitalis, a prescription drug derived from the foxglove plant. Doctors have used this drug to treat heart problems since the 1700s. Producing a single dose of digitalis requires 0.0007 ounces of dried foxglove leaves.v In contrast, a 200mg garlic pill requires 30 to 40 blooms of garlic, weighing about 4 pounds.vi So the factory isolates the active ingredient from 4 pounds of garlic and crams it into one pill. Believing that pill is just a food is a little hard to swallow.

Impurities in supplements have already done serious harm. L-Tryptophan was a supplement used as a sleep aid. In the early 1990s, this pill harmed hundreds of people, and killed at least 31.vii The active ingredient was isolated from bacteria grown in vats. When the analysis of the carnage was complete, an impurity had caused all the harm.viii

Last summer, the FDA issued new rules to tighten the reins on supplements. They take effect for large companies on June 25, 2008. For smaller companies, they phase in over the next two years.ix

The new regulations establish guidelines for the manufacture of supplements. Unfortunately, several major problems limit their effectiveness.

  1. The new regulations on supplements are still not as strict as the regulations on conventional drugs.x Until they are, consumers will not know that their Glucosamine is as pure as their Tylenol.

  2. The FDA does not have the resources to enforce the regulations.xi Since the industry knows this, there will be less motivation to comply.

  3. When the FDA tries to enforce the rules, they will face legal challenges. Experts believe it is possible to argue that the new regulations exceed the FDA’s legal authority to regulate supplements.xii

  4. According to at least some observers in the industry, the regulations are full of loopholes. Therefore, companies will be able to circumvent the government’s intentions.xiii

For all of these reasons, the prospects for meaningful improvement are dim.

Fortunately, private companies have stepped into this regulatory vacuum. ConsumerLab.com (CL) and U.S. Pharmacopoeia (USP) test finished products for purity. Founded in 1820, USP is a nonprofit company with a proud history of ensuring the purity of prescription and non-prescription drugs. CL is a newer company that focuses primarily on supplements. The Natural Products Association and NSF International both focus on the standards for the manufacturing process. All four of these companies have websites that explain their programs regarding supplement quality.

Since the new FDA regulations will not solve the industry’s purity problem, the warning for the consumer remains caveat emptor — let the buyer beware.

Footnotes:

i Donald Marcus and Arthur Grollman, “Botanical Medicines: The Need for New Regulations,” New England Journal of Medicine 347 (2002) 2073-2076.
ii Robert Saper et al., “Heavy Metal Content of Ayurdevic Herbal Medicine Products,” Journal of the American Medical Association 292 (2004) 2868-2879.
iii “FDA Warns Consumers about Dangerous Ingredients in ‘Dietary Supplements’ Promoted for Sexual Enhancement,” FDA News, July 12, 2006.
iv Food and Drug Administration, “Dietary Supplement Health and Education Act of 1994,” December 1, 1995.
v www.botanical.com/botanical/mgmh/f/foxglo30.html.
vi www.astrologyzine.com/alli-c-odorless-garlic.shtml.
vii Eugene Braunwald, et al., eds., Harrison’s Principles of Internal Medicine, 15th ed. (New York: McGraw-Hill, 2001), 1946.
viii John Fagan, “Summary of the Tryptophan Toxicity Incident,” undated.
ix Food and Drug Administration, “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts,” June 22, 2007.
x Covington and Burling LLP, “FDA Releases Long-Awaited Dietary Supplement Current Good Manufacturing Practices Final Rule.”
xi Megan Pellegrini, “Regulating Healthy Lifestyles,” Contract Manufacturing and Packing Magazine, January 31, 2008.
xii Covington and Burling.
xiii Rick Liva, “New FDA cGMPs for Supplements: Smoke of Substance?” Integrative Medicine 6 (2007) 28-32.