FDA warns that tainted products marketed as dietary supplements are potentially dangerous – Anti-Doping Research’s Dietary Supplement Survey – A strategy in response

The Good, the Bad, and the Dirty in the Dietary Supplement Industry – Anti-Doping Research’s (ADR) Dietary Supplement Survey

Despite being widely available today, dietary supplements can contain unsafe and illegal substances that pose significant health risks to consumers.  Novel designer steroids, stimulants like ephedrine, pharmaceutically active ingredients like sibutramine, and other untested or unsafe ingredients continue to slip into the dietary supplement marketplace.  The FDA has responded with a significant and laudable new effort to work with the industry to combat the issue as described in, “FDA: Tainted Products Marketed as Dietary Supplements Potentially Dangerous.”  We would like to assist the effort through ADR’s Dietary Supplement Survey, for which we are currently raising financial support.

In ‘Tainted Body Building Products,” the FDA issued a warning that, “FDA cannot test all products on the market that contain potentially hidden ingredients.  Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”  The numbers of tainted products are vast and the problems real.  According to the press release, “In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.”  Yet this is just a small fraction.  We would like to use our experience to help test and expose more, one of the primary goals of our Dietary Supplement Survey.

In the words of the FDA Commissioner, Margaret A. Hamburg, “These tainted products can cause serious adverse effects, including strokes, organ failure, and death.”  The dangers, as we know first-hand, are all too real, as we have dealt with numerous cases of acute liver injury in young adults who have used such products.  Colleagues such as Don Hooton have had lives forever changed by the suicide of a son using steroids to pursue athletic advancement.  Unfortunately, the issues are not isolated to body-building products as they span other categories like weight loss and sexual enhancement as well.  If such products are manufactured in the same facilities as legitimate supplements, the potential for contamination is also a concern.

In the FDA Letter to Industry, a fine point is made. “These products not only pose risks to consumers,” it states, “but undermine confidence in legitimately marketed dietary supplements in these and other categories.”  The majority of the dietary supplement industry produces products that do not contain illicit ingredients or contaminants and that should also be showcased.  In the letter, the “FDA is also seeking continued input and collaboration from the trade associations to educate the industry about this problem and to develop strategies to combat it.”

We believe that ADR’s Dietary Supplement Survey initiative could be such a strategy.  To sum up our goals:  We aim to explore which products are good, which products are bad, and which products exhibit contamination with low but potentially harmful levels of illicit ingredients.

More specifically, we will perform focused testing on problem categories to expose dangerous new products.  We will also conduct testing on a variety of randomly selected products to evaluate the prevalence of contamination and to demonstrate that the majority of products are indeed clean.  In the process, we will help audit the current retail environment to assist with enforcement and will characterize new supplement ingredients that have the potential to cause harm or lead to a positive drug test.  The results of our work will available via an interactive website portal complete with testing data, public service announcements and more.

As a public charity, Anti-Doping Research, a leader in performance-enhancing drug and toxicology research and testing, is working to raise $1.5 million to conduct the Dietary Supplement Survey.  We hope to gain broad support from a variety of sources to provide for a collective solution.  We have reached out to our friends in the dietary supplement community, the sporting community, anti-doping, collegiate and high school athletics, sporting sponsors, pharmaceutical companies and others in pursuit of support.  We would also welcome the involvement of the general public through volunteer activity or small contributions.  All donations are tax deductible.

If you have any questions, please contact us at 310-482-6925 or by e-mail at dcatlin@antidopingresearch.org or ocatlin@antidopingresearch.org.

Consumers, athletes and other elite professionals deserve a marketplace offering legitimate and safe dietary supplements.  With your help, we are confident that we can help make this happen.   Please join us and help support this important initiative with your contribution today.

Dietary supplement manufacturing and why designer steroids should matter to the general public

Perhaps you might think that you are far removed from the issues related to designer steroids.  Some see it as a problem for professional or Olympic sport to deal with but don’t see the issue influencing their daily lives.  Well, if you take dietary supplements on a regular basis, as more than half the population of the United States does, according to a recent Nielsen survey, designer steroids should matter to you.

Why, you might ask; I only take vitamins or herbs?  Well, the answer comes from the manufacturing process, which often occurs in co-packing facilities in the case of dietary supplements.  Co-packers simply mix and package the formulas provided by various supplement manufacturers and turn them into final products.  If your vitamin, protein powder, amino acid supplement or other product is processed in the same facility as one of the many designer steroids that continue to be produced you may have a problem.

A quick tour of a co-packer manufacturing facility illustrates the potential for contamination…

First, the raw materials are obtained and are warehoused for use.

The raw materials

The ingredients for a particular formula are then gathered and sent for measuring.

Gathering raw materials on pallet

The ingredients are weighed out according to the formula for the product.

Weighing the ingredients

The ingredients are combined in a huge blender to be mixed for hours.  If the blender is not completely cleaned and sanitized between mixes of different products, one can see how cross-contamination between products can occur.

The giant blender

If your protein powder is produced just after a designer steroid, one can see how cross-contamination might occur.    Many co-packers in the industry make an ethical choice not to participate in the manufacturing of dangerous products like designer steroids, but not all.  O.K., so there are regulations in place to protect against possible contamination of the finished products with potentially harmful unlabelled ingredients right?  Wrong.  (In fairness to the many competent and capable co-packers we should mention that we test products regularly from the facility shown above and have yet to find any contamination)

Certainly dietary supplement industry regulations have come a long way.  The phase-in of the Current Good Manufacturing Practice (CGMP) for dietary supplements over the last few years is likely to significantly improve quality of products as manufacturers are held to the new standards that CGMP dictate.  All manufacturers are now subject to CGMP, although the industry recognizes that the benefits will only be as good as the enforcement and auditing of the CGMP.

The new CGMP requirements, however, DO NOT include the need to test finished goods for contaminants such as designer steroids.  This is surprising given the prevalence of such compounds still today, even though they should be illegal to put in supplements.  CGMPs do require raw materials to be tested for purity prior to being formulated in the product and they also require testing for adulterants like arsenic or lead.

Some argue that purity checks will ensure that contaminants like designer steroids do not enter the marketplace.  However, if you explore the concept of purity testing and you realize that purity checks are often done at the microgram level, the problem is exposed.  Microgram testing is done at parts per million, testing for contaminants like designer steroids is usually done at the parts per billion level (nonograms).  Say you do a purity check on an ingredient and it comes back 99% pure after testing at the microgram level.  Well, how do you know the other 1% does not contain a hidden steroid, stimulant or otherwise unlabelled pharmaceutical ingredient? 

Is it O.K. if your protein powder, amino acid, or vitamin contains microgram quantities of a steroid or stimulant?  How does that magnify itself in your body with daily use of a protein powder where a serving size might be 100 grams, three times daily?  We don’t think that such contamination is acceptable as it could reach levels significant enough to lead to harm for a consumer.  Certainly, such levels of contaminants could cause positive drug tests for elite professionals like athletes or police officers; in fact, even contamination in the low parts per billion can lead to positive drug tests.

We would like to evaluate how prevalent contamination is in today’s supplement marketplace.  Nobody knows the scope of the issue since there are no requirements to test.  We want to survey the industry to characterize the issue through random sampling of a variety of products.  We also want to work to expose the bad products in the industry, like the new designer steroid options that continue to pop up daily.

If you are interested in such issues and would like to support our efforts to conduct a survey of products from the industry, please reach out to us at info@antidopingresearch.org or explore our Dietary Supplement Survey concept, which we are currently raising funding to conduct.  All contributions to our 501c3 public charity Anti-Doping Research are tax deductible.  We would welcome your support of this public-health initiative as we believe it will lead to improved consumer protection, better regulations, and much-needed improved quality control of dietary supplements.