In early October 2014, a number of nutritional supplement manufacturers discontinued their production and distribution of AMP Citrate, a stimulant popular in many workout supplements.
VPX used AMP Citrate in its popular (and recommended) thermogenic fat-burner MD2. VPX subsequently discontinued manufacturing the product, and consumers quickly snapped up the remaining supply. Similarly, supplement upstart Chaos & Pain – which used AMP Citrate in a number of its products – had a production run worth $70,000 thrown into limbo by the FDA’s abrupt decision.
C&P’s minister of propaganda, Jamie Lewis, had a typically colorful take on the ordeal.
At the time, the FDA had not even taken action on AMP Citrate. To date, it still has not – although it is under pressure to do so. How, then, did its supply dry up so quickly? The answer lies not in anything the FDA has done yet to AMP Citrate, but to what it has already done to 1,3 DMAA, a substance similar to AMP Citrate. Because of the relative intensity with which the FDA acted to declare DMAA illegal and impound then-existing supplies of the substance, manufacturers and distributors likely saw the writing on the wall for AMP Citrate. Rather than have their inventory impounded and destroyed, backing away from the AMP Citrate market altogether seemed like the prudent choice.
This raises a larger question, though, of just how the FDA can swiftly deem a supplement illegal and have it removed from the market. Whether you remember your high school civics class, remember the opening credits for Law & Order, or just have a sense of fair play, it seems curious that the FDA can just ban something overnight. For people who know more about the legal system – but perhaps lack the firsthand experience to appreciate that its reach is shockingly limited – the notion of due process comes to mind. When dealing with administrative agencies like the FDA, though, much of that goes out the window.
What Is the FDA?
The FDA is the US Food and Drug Administration, an administration within the US Department of Health and Human Services. The FDA’s existence is provided for in the federal Food Drug and Cosmetics act, and exists to enforce those statutes. This is actually a very broad undertaking, as the FDA has power over food and nutritional supplements, drugs, medical devices, radiation-emitting products (from mammograms to tanning beds to microwaves), blood and vaccines, and even veterinary supplies.
Because of the FDA’s scope, it often abuts other federal agencies. For example, both the FDA and the Nuclear Regulatory Commission have to concern themselves with radiation-emitting devices. Concerning supplements, and whether or not they are drugs that require prescriptions, the Drug Enforcement Agency (DEA) picks up where the FDA leaves off, and can criminally prosecute distributors of items that the FDA has deemed to be drugs, rather than supplements. Even more confusingly, even though the FDA has control over what is deemed a supplement, the Federal Trade Commission (FTC) has authority to enforce its regulations relating to the marketing of supplements and the claims made in promoting pills and powders, even though the FTC has no authority over the substances in the supplements themselves.
How Does the FDA Determine What’s a Supplement and What’s a Drug?
What the fitness community refers to as a “supplement” has a specific definition under the Food Drug and Cosmetic Act. Specifically, a dietary supplement must contain a “dietary ingredient” intended to add more nutritional value to the diet. The FDA requires that the dietary ingredient in supplements be one or a combination of only the following substances:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by people to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, or extract
This FDA’s list starts with concrete substances – vitamins and minerals – and quickly veers off into abstraction. Grouping concentrates, metabolites, constitutents and extracts together in one bullet point illustrates the potential breadth, and vagueness, of the FDA’s rules. In some instances, the FDA’s list begs the question; it assumes, for example, that what may be metabolized is also classifiable as a dietary supplement.
The FDA also allows for the introduction of “new dietary ingredients” upon providing proof of prior use to the FDA, or by creating the new ingredient out of established dietary ingredients that have been present in the food supply since October 15, 1994. This is an exception to the FDA’s normal position of allowing products to reach market before taking action. Even then, the FDA normally acts only after a product is on the market – and adverse effects have been reported – before declaring that a supplement contains a “new dietary ingredient” that cannot be sold without approval.
If a supplement does not qualify under these definitions of a dietary supplement, it is unlawful to manufacture and market them as foods. In the worst-case scenario, these substances are classified as drugs, as the FDA threatened to do to Piracetam in 2010. As such, they will be subject to the crushingly expensive drug approval process that has contributed to the high cost of pharmaceuticals, and led to the consolidation of that industry. Although loopholes exist for supplements the FDA classifies as drugs to remain available for purchase, the FDA’s declaration that a substance is a drug is a de facto death sentence. As large as the nutritional supplement industry is, it is but a speck compared to big pharma.
How the FDA Removes Products From Market – a Real Life Example.
The FDA’s process for investigating whether a dietary supplement actually is a supplement, as opposed to a drug, is lengthy and governed by various statutes and regulations. Because supplements do not require FDA approval before reaching market, consumer harm generally is needed before the FDA even knows to take action. The FDA’s investigative mechanisms are triggered by consumer complaints sent to the FDA. This process can ultimately lead to a ban on a specific substance, whether it is declared to not be a dietary supplement, or determined to be a drug instead.
Because the FDA’s formal investigation and action process takes so long, though, the administration has a range of intermediary steps available to it. First, the FDA may send warning letters, cautioning manufacturers and distributors to stop their manufacture and distribution of a product. When the FDA began sending warning letters to distributors of Piracetam in the early 2010’s, the distribution market quickly contracted for fear of government action. A substance that was once readily available on Amazon.com quickly receded to the shadows, available on less-renown websites, and primarily in powder form. For example, here is the warning letter the FDA sent to USP Labs over its manufacture and sale of Jack3d, back when it contained 1,3 DMAA.
The FDA’s power goes beyond mere letters: It can effectively impound a manufacturer’s property and keep it off the market. This remedy is called “administrative detention,” and allows the FDA to “detain” food products for up to 30 days. As the procedure’s name suggests, this is an administrative remedy, and requires only that a FDA representative has reason to believe that the product is adulterated or misbranded. This step precedes a seizure or an injunction, and does not provide the manufacturer with the ability to be heard in the manner a motion it would in opposing a temporary restraining order (a form of injunctive relief).
In order to act on dietary supplements, the FDA looks to reported incident of adverse effects from consumers. In the case of DMAA, the FDA received more than 100 consumer reports of adverse effects, including six deaths. While the individual reports to the FDA may be explained away – for example, a report arising from a teenager, elderly person, or physically ill individual who took well over the recommended dosage – the aggregate number of reports can prompt the FDA to act on what it perceives to be trouble substances.
Based on how the FDA acted on DMAA, it was reasonable to expect similar treatment for AMP Citrate. A powerful supplement lobby, the Center for Responsible Nutrition, urged the FDA to act on AMP Citrate as the “next DMAA.” Adding their voices to the chorus demanding action were Harvard Medical School associate professor Pieter Cohen, and United States Senators Dick Durbin and Richard Blumenthal. While these are not the consumer reports of adverse effects the FDA normally looks to before acting, they are hardly voices a federal administration can ignore. Without sending a single letter about AMP Citrate, the rest of the world accepted the FDA’s adverse actions as a foregone conclusion. Within weeks, companies that used AMP Citrate in their products had discontinued them and, in some cases, re-formulated their offerings.
Because the FDA does not require prior approval of dietary supplements before they can be sold to the public (as opposed to drugs, which require an exhaustive and costly review), the process for determining whether a product properly is on the market can destroy supplement manufacturers. The FDA’s determinations generally are made after a new supplement is available to consumers. Often, the impetus for the FDA to ban a supplement does not even arise until it has been introduced to the market. Thus, unless the process changes – or manufacturers beg the FDA for approval before releasing a product – the FDA’s destruction of entire products is a feature, rather than a bug, of its operation. While AMP Citrate is not the first substance for the FDA to force out of the market, even without official action, it will not be the last.
<NOTE> This was the first article from our resident legal mind J. Malcolm “Jay Devoy. Jay is a business litigator in Las Vegas, Nevada who represents individuals and small businesses in disputes over contracts, intentional conduct, and intellectual property. Based on his interest in fitness and nutrition, Jay is interested in the supplement industry and its interaction with federal law. Expect much more from him in the future. He can be reached for consultation via email: firstname.lastname@example.org
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