In recent years, the United States Food and Drug Administration (hereafter “FDA”), have mobilized their efforts to address what has become a serious public health problem. The dietary supplement industry is a multi billion dollar a year consumer driven industry growing with each passing year. In addition to consistent expansion of supplement brands, competition for higher profit margins, and minimal capacity to regulate all genres of dietary supplements, the FDA is confronted with a monumental task. The cancer of greed has slowly metastasized to terminal levels. Manufacturers and distributors of dietary supplements now actively lace their formulas with prescription drugs or analogs fully aware of the dangers posed to consumers. People who run these operations knowingly adulterating their supplements are true criminals motivated by greed and a lack of conscience for the risks to the consumer.
These tainted products have led to tragic medical consequences including liver and kidney damage, stroke, pulmonary failure and death. Tainted products are problematic, but people and organizations that intentionally taint their supplements and products are far worse than the neighborhood drug dealer. The local drug dealer thriving in every town in America illegally sells and distributes his/her drugs to a consumer base privy to what they are purchasing and the potential dangers from ingesting those chemicals. Dietary supplement manufacturers and distributors aware of selling tainted supplements are far worse because their consumers are ignorant to the dangerous chemicals being added.
The three categories of supplements consistently adulterated with potential toxic substances are weight loss, sexual enhancement, and body building products. The FDA, national trade associations representing the dietary supplement industry and various regulatory commissions are all struggling to halt these deceptive practices. At the FDA website, they clearly point out to site visitors their enforcement procedures and consumer advisories for tainted products merely cover a small fraction of the tainted over-the-counter products on the market. The magnitude of the problem is gigantic.
Clearly, manufacturers who knowingly lace their formulas and distributors who are aware they are selling tainted supplements to consumers are engaged in criminal activities and deemed as participating in deviant behaviors. A forensic psychologist is trained to identify aspects of the human condition related to criminal behavior, deviance, and the motivation of criminal behavior. Following is a forensic psychologist’s rationale for people and organizations engaged in such corrupt actions.
Research of the dietary supplement industry related to tainted products is a daunting task. The three categories of supplements the FDA has identified first needs to be investigated. Weight loss, sexual enhancement, and body building supplements have the highest rate of tainted substances. These three categories share a common theme. All three categories are involving populations of individuals seeking performance enhancement or image enhancement. Two of these three categories, are formulas designed to help people with perceived negative aspects they are trying to improve. Consumers purchasing weight loss supplements are hoping to shed pounds. The vast majority of consumers purchasing sexual enhancement products are men looking to enhancement their genital organ. Body building supplements are for bodybuilders, weightlifters, athletes, and people looking to improve their physiques. Although the three populations are different, they all share one common theme. This theme is based on the theory of “exhausting all options.”
All three populations are investigating and purchasing supplements in hopes of achieving goals they perceive as necessary to attain their goals. The bodybuilder seeks greater definition of muscle mass, the over weight person hopes to shed pounds, and men purchase sexual enhancement products to help them obtain and sustain an erection. These segments of the population are willing to consume supplements if the results of consumption benefit their goals for improvement. There is a high probability that all three of these groups resort to supplements because other methods have either not been beneficial or does not meet their expectations. Hence, they practice the concept of “exhausting all options” and research these products. Unfortunately, the dietary supplement industry relies on the consumer’s dire need to find an effective product. An unknown percentage of these companies develop formulas which are illegal and potentially dangerous for the monetary gains.
The FDA fully admits they do not have the capacity to investigate every supplement company due to the industries sheer size. Minimal regulations, low rates of enforcement, and a consumer base willing to spend billions of dollars each year have created an environment perfect for the criminal mind to engage in. At present, the consequences for intentionally tainting dietary supplements and offering to consumers for retail tainted supplements grows exponentially each year. The opportunity for succeeding with a criminal mind is “ripe for the picking.” The manufacturing and distribution of dietary supplements is both legal and accepted by society. Legal, accepted, and financially booming sets the stage for criminal intent. The cocktail for the criminal mind is clearly obvious. An industry generating billions of dollars a year, minimal consequences for deceptive practices and a high demand by consumers combine for the criminal mind to flourish. The environment for opportunity and greed becomes a viable option.
Intentionally tainting supplements for consumer consumption without fear of consequences motivates the criminal mind to become creative in design. Even the drug dealer selling his/her illicit chemicals must practice marketing their products with a low profile. Although the neighborhood drug dealer survives with a criminal mind, the manufacturer and distributor intentionally marketing tainted products thrives with his/her criminal mind, markets products attempting to be as high profile as possible, and feeds their greed at the expense of the consumer.
Within the dietary supplement industry, the difficulty for the FDA, OCI, DEA, law enforcement, and the legal system capacity to identify and prosecute those intentionally tainting products is multifaceted and complex. Given the size of the industry alone makes complete coverage impossible allowing those with criminal minds flourish unfettered by fear of prosecution. Despite the commitment of these federal and state agencies, the criminal mind intentionally tainting supplements continues to reap the rewards of their actions. The unfortunate reality is the spoiling of the entire supplement industry due to these charlatans.
Although no statistics seem to exist to prove this writers hypothesis, it is suggested that the majority of supplement companies that seek to produce and market products adhering to The Dietary Supplement Health and Education Act of 1994 become entangled with the FDA for unknowingly having products which test positive for illegal substances. Although the FDA holds distributors of dietary supplements accountable when their products they market test positive for tainted substances, the reality is many of these organizations do so unintentionally without knowledge of the contaminants. Unfortunately, the FDA has no mechanisms to evaluate if these companies are intentionally tainting their products to maximize profit. The only methodology confirming intentional sale of tainted supplements occurs when evidence can be compiled the distributor is aware of the illicit substances in their products, but continues to market them anyway.
For organizations that are confirmed selling tainted products via advanced chemical testing procedures, the consequences can range from seizure of products, cessation of sales, and on some occasions, prosecution. Once these companies have been selected as problematic by the FDA, the financial losses and attorney fees involved often force closure or bankruptcy. Given the priority to protect consumers is the mission of the FDA, honest organizations who inadvertently purchase tainted ingredients without intent or knowledge at times must close their business from financial losses. This harsh reality is not the fault of the FDA, but at fault are the national and international manufacturers tainting their formulas without the retailer’s knowledge and endeavoring to expand their market base of retailers worldwide by manufacturing tainted formulas.
The question comes down to intent. Intent to manufacture and distribute tainted supplements void of concern for the risks to consumers are a group of criminals requiring serious prosecution. The concept of intent has many definitions and complicated to succinctly define to the lay person. The legal definition available online as it relates to intentionally selling tainted supplements is defined as criminal intent. Criminal intent is called mens rea, which refers to a criminal or wrongful purpose. Mens rea is Latin for “guilty mind.” In criminal law, it is viewed as one of the necessary elements of a crime. If a person innocently causes harm, then he/she lacks mens rea. Under this concept, an accused defendant should not be criminally prosecuted if intent can not be established.
Criminal law has attempted to clarify the intent requirement by establishing two concepts, specific intent and general intent. Specific Intent refers to a particular state of mind that seeks to accomplish the precise act that the law prohibits. In some circumstances, the category of specific intent means an intent to do something beyond that which is done, such as assault with intent to commit rape. The prosecution must show that the defendant purposely or knowingly committed the crime at issue. In relation to a distributor or manufacturer being prosecuted using the legal definition of specific intent, evidence must establish the person and/or organization tainted their supplement formulas or purposely marketed and sold tainted supplements fully aware the risk to a targeted consumer or group of consumers. Even more complicated is the second legal concept of intent called General Intent.
General intent refers to the intent to do that which the law prohibits. Under this concept, it is not necessary for a prosecuting attorney to prove the defendant intended the precise harm or the precise result that occurred. The law will infer that the defendant had a general intent. Under the concept of general intent, the manufacturer or distributor who knowingly and intentionally produces and/or offers for retail tainted products can be prosecuted. The unfortunate consumers who suffer physiological damage from consuming tainted supplements were not the target of these unscrupulous supplement manufacturers and distributors, but victims nonetheless. Although specific intent is more heinous because the intent is targeted, general intent is equally as dangerous.
The Diagnostic and Statistical Manual of Mental Disorders (hereafter “DSM”), is published by the American Psychiatric Association and outlines a language and standard set of criteria for the classification of mental disorders. It is used in the United States and in varying degrees around the world, by clinicians, researchers, and policy makers. The DSM is considered an important manual for most professionals working in the mental health and behavioral healthcare field. The DSM maintains a set of disorders called personality disorders. Personality disorders outlined in the DSM defines a personality disorder as an enduring pattern of inner experience and behavior that differs markedly from the expectations of the individual’s culture, is pervasive and inflexible, has an onset in adolescence or early adulthood, is stable over time, and leads to distress or impairment. Personality disorders are a long-standing and maladaptive pattern of perceiving and responding to other people and to stressful circumstances. Within the category of personality disorders, ten disorders have been identified which are distinct in their manifestations.
In relationship to these ten personality disorders, there is one called antisocial personality disorder and may define the group of manufacturers and distributors which intentionally taint their formulas with potentially dangerous substances or market these supplements knowing their supplements are tainted. Antisocial personality disorder is a type of chronic mental illness in which a person’s ways of thinking, perceiving situations and relating to others are abnormal and destructive. People with antisocial personality disorder typically have no regard for right and wrong. They may often violate the law and the rights of others. They may lie, practice deception, attempt to manipulate, and often engage in illegal activities because they are unable to fulfill responsibilities to family, work or school in an adaptive manner.
Hence, people who suffer from antisocial personality disorder may seek to victimize others for personal gain and lack empathy for those they harm in their pursuit for personal benefit. Some suggest the majority of felons serving prison sentences would fit the criteria for antisocial personality disorder if this population of criminals were evaluated by psychologists or psychiatrists. The population of people intentionally tainting their dietary supplements void of concern for the risks to consumers would likely meet criteria for this dangerous disorder.
In conclusion, the FDA has mobilized their efforts to address a contemporary serious public health problem. Manufacturers and distributors of dietary supplements actively lace their supplement formulas with prescription drugs and/or analogs fully aware of the medical dangers posed to consumers. People who run these operations intentionally adulterating their supplements are true criminals motivated by greed and a lack of conscience for the risks to the consumer. Reports of injury and even death from the use of these illegal supplements have been reported to the FDA. These reason(s) for injury and death are caused by supplements deceptively labeled or containing undeclared ingredients. These supplements often include the same active ingredients as drugs already approved by the FDA. Analogs are defined as close copies of FDA approved drugs and novel synthetic steroids that do not qualify as dietary ingredients are two substances becoming prominent adulterants.
The enforcement arm of the FDA, Office of Criminal Investigations, is fully committed to investigating and supporting the prosecution of those who may endanger the public’s health and safety by manufacturing and selling unsafe products. Given the size of the dietary supplement industry, the FDA and supporting agencies admit they can only target and test a fraction of the companies presently involved marketing and selling dietary supplements.
Although presumed by this writer the majority of companies who have products which test positive for illegal chemicals are not intentionally doing so, the FDA has no way to ferret out if these companies are engaged in deceptive practices. It is the smaller population of companies and professionals which intentionally taint and/or market their products which need to be apprehended. It is these individuals who walk through life motivated by their criminal mind and at a high probability for experiencing antisocial personality disorder. At present, there is no valid methodology to pinpoint these criminals and their actions negatively taint the entire supplement industry, just as their tainted products are sold to consumers negatively impacting their medical health.
Bodybuilding supplements, male enhancement pills, and weight loss diet supplements are the three categories of dietary supplements the FDA has alerted the nation about. Companies who sell these are encouraged to implement the following recommendations to reduce their chances of creating risk to consumers purchasing their products. The FDA mentions five trade associations they interface with and dietary supplements companies should investigate joining them. They are the Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance (UNPA), Consumer Healthcare Products Association, and American Herbal Products Association. It is also recommended to bookmark and visit often the websites hosted by the U.S. Food and Drug Administration and the Center for Food Safety and Applied Nutrition.
Website developers working for dietary supplements companies are recommended to attach links encouraging site visitors to the FDA, dietary trade associations, and any other organizations designed to protect consumers. The FDA also has MedWatch, which can be added to websites so consumers can be alerted to recent products which have tested positive for adulterants. It is the responsibility of dietary supplement companies to institute whatever measures necessary to protect consumers from consuming tainted supplements. It is also highly recommended to allocate a portion of the organizations advertising budget to educating the consumer on the use of dietary supplements and topics involving health, fitness, nutrition, and overall healthy living.
Dr. Michael Nuccitelli is a New York State licensed psychologist and a clinical and educational consultant for Herberex Inc. and Goliath Labs Inc. Dr. Nuccitelli areas of expertise include dietary supplement compliance guidelines, sports nutrition, human sexuality, forensic psychology, health/fitness, and psychiatric/psychological issues.