Economic Adulteration of Nutritional Supplements

Economic adulteration is the single most dangerous threat to the viability of the nutritional supplement industry.  While adulteration of materials may occur accidentally, quality controls are now in place to avoid, address, and correct this.  When materials are modified intentionally, it may be difficult to fully evaluate their quality without thorough examination.  This examination involves visual identification and chemical analysis. 

 Hoodia!  

Defining Economic Adulteration in Relation to Herbal Supplements

The US Food and Drug Administration (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." 

Intentional adulteration comes in several flavors:

• Inappropriate enhancements

• Substitutions

• Mislabeling
• Dilution of materials

• Deliberate absence of quality control

Inappropriate enhancements

Sometimes pharmaceuticals or unapproved chemical compounds are added to a product to enhance physiological effects.  This is a common occurrence with products designed to be male sexual enhancers.  Botanicals with substantiated enhancement ability are rare and expensive, so crude filler plant material may be augmented with small amounts of a drug like sildenafil citrate (Viagra) for actual biological effect [1].  This may be extraordinarily dangerous since these drugs have many contraindications and adverse interactions with other medications. LINK to article

Substitutions

The most common form of substitution is to knowingly use other plant parts or related plant species that are easier to get.  Research and substantiation usually focuses on a single plant part and species.  The constituents of this species are analyzed, then animal and human trials are performed.  These studies probe for  safety and efficacy [2].  Often, related species with unknown constituent profiles are procured due to cheaper cost and ease of acquisition. These are assumed to be viable alternatives, but no research has been done.  Usually these plant alternatives are ineffective, and sometimes even toxic.

Mislabeling

Misrepresentation of a formula ranges from stating wrong species and dosages to indicating incorrect concentrations of a material.  For instance, there are products out there claiming  they include 20:1 concentrates of rare and expensive herbs like hoodia (Hoodia gordonii) [3].  These are extraordinary concentrated forms of an herb, that would be outrageously expensive. 

Dilution of Materials

Sometimes powerful herbs are diluted in a formula out of fears of adverse effects related to consumer noncompliance.  Usually circumstances are less noble…   expensive materials are often stretched by the addition of cheap fillers like maltodextrin, titanium dioxide, or crude unconcentrated forms of the plant.  More sophisticated forms of dilution may involve the inclusion of specific materials that mimic the supposed herb.  For instance, sometimes buckwheat-derived rutin is added to the hugely popular herb Ginkgo biloba. 

LINK  

Deliberate Absence of Quality Control

Turning a blind eye to questionable materials is becoming more difficult, but still happens.  Large barrels or bags of a supposed ingredient may be purchased online from international sources -usually at prices discounted 30% or more.  These are often accompanied by bogus certificates of authenticity.  This is becoming more difficult in the US since guidelines are now in place for monitoring of materials from source to manufacturing.  Random analysis is now performed by the FDA, and manufacturers that come up short are addressed [4, 5].  LINK

Good Manufacturing Practice

Many countries have enacted good manufacturing practice (GMP) mandates for herbal manufacturing.  These are set up in an attempt to avoid the most obvious forms of adulteration.  Sources of materials must be reputable and samples must be analyzed for quality.  Verification involves tactile, odor, microscopy, and advanced procedures like TLC and HPLC.  Every step in production is controlled, observed, and documented.  Standard operating procedures (SOPs) are created and on hand for each step.  Systems are in place for monitoring material degradation, expiration dates are proposed, and a route for recall is in place.  Consumer complaints and possible adverse effects are also documented.   FDA LINK

The tightening regulations in the herbal-nutritional supplement industry must be viewed as an opportunity.  The reputation of this industry relies on safety and efficacy.  These standards insure a base level quality assurance.  Consumers must be assured they are getting exactly what they pay for or the business falls apart... 

Resources

1. Wollein, U., W. Eisenreich, et al. (2011). "Identification of novel sildenafil-analogues in an adulterated herbal food supplement." Journal of Pharmaceutical and Biomedical Analysis 56(4): 705-712.

2. Calixto, J. B. (2000). "Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)." Brazilian Journal of Medical and Biological Research 33: 179-189.

3.  van Heerden, F. R., R. Marthinus Horak, et al. (2007). "An appetite suppressant from Hoodia species." Phytochemistry 68(20): 2545-2553.

4.  De Smet, P. A. G. M. “Overview of Herbal Quality Control.” Drug Information Journal 33, no. 3 (1999): 717–724.

5.  Apers, S., T. Naessens, S. Van Miert, L. Pieters, and A. Vlietinck. “Quality Control of Roots of Eleutherococcus Senticosus by HPLC.” Phytochemical Analysis 16, no. 1 (2005): 55–60.