The Dietary Health and Education Act of 1994 (DSHEA) represents the effort of thousands of Americans who wanted the freedom to choose natural health products that contribute to good health. The natural products industry, consumer groups and various Congressional members joined ordinary citizens in the extraordinary pursuit of this freedom, a hard-fought legislation designed to provide a reasonable path to market for dietary supplements, while safeguarding the public from potential dangers. "We worked hard to create a regulation that covered all the areas of concern," said Sen. Orrin Hatch (R-Utah), one of the co-sponsors of the legislation and a longtime advocate of the importance and safety of the greater supplement and nutrition industry.
DSHEA gave FDA many powers, including the ability to develop, implement and enforce health claim guidelines and good manufacturing practices (GMPs) for supplements. Slow in carrying out these mandates, FDA made little progress on the GMP front by the time the industry and Congress responded to growing criticism and suspicion of the safety of supplements by supporting and enacting, respectively, the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006, requiring manufacturers and responsible parties to log serious adverse event reports (SAERS) and submit them to FDA. At present, these various regulations require manufacturers to provide scientific support for any health claims made; test incoming materials and perform various manufacturing and storage procedures by strict methods documented fully in paperwork subject to FDA inspection; and record any AERS, serious or not, and submit SAERS to FDA within a designated timeframe. On top of this, regulation on new dietary ingredients (NDIs) requires manufacturers to notify FDA 75 days before marketing any ingredient, which was not in regular commerce before Oct. 15, 1994 (unless on the list of specially grandfathered ingredients). By this, the ingredients not subject to the NDI rule are assumed well-known by FDA.
Given all these regulations, why is the supplement industry suffering from increasingly negative attention from the media, government, consumer groups, sports organizations and many other Americans?
The biggest problems drawing the negative attention are rooted in quality control (QC) issues, although misleading and disease claims certainly play a significant role. Among the criticism lobbed at the supplement industry are products either not containing what is on the label or containing compounds not on the label. The greatest harm in a product falling short of the labeled amount of a nutrient or active ingredient is that it doesn't work and leaves the customer dissatisfied. However, for products containing unlabeled substances—adulterants—there is potential public health risk, which is the basis of the recent scrutiny of DSHEA. Economic adulteration also hurts the marketplace for legitimate products by offering artificially low prices (due to the cheap adulterants used) and bringing negative focus and stigma on the product category—one bad apple spoils the bunch.
One of the challenges in combating economic adulteration is getting a handle on what kinds of adulteration exist in the market.
FDA defines economic adulteration as: “The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” In recent years, the agency has concentrated its anti-adulteration efforts on sports nutrition, sexual dysfunction and weight-loss products that are marketed as supplements, but contain undeclared drug compounds found in pharmaceutical products of similar focus.
In these product categories, adulterators prey on consumers desperate to build more muscle mass, lose weight or solve a sexual dysfunction. For such criminals, consumer satisfaction is just a matter of pharmaceutical spiking.
For example, FDA looked at MetaboSlim, from Confidence Inc., a couple of years ago and found it contained sibutramine, a drug approved by FDA for use as an appetite suppressant. The company recalled the product in 2007. More recently, Young You Corp. recalled four products it was selling as weight-loss supplements, after FDA found they also contained sibutramine. In both cases, product was sold on the Internet or direct from the manufacturer.
FDA has warned consumers about such products, which it considered unapproved drugs, noting its laboratory tests have found sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat, and phenolphthalein in weight-loss products being as supplements or over-the-counter (OTC) products.