FDA DESTRUCTION OF THE DIETARY SUPPLEMENT INDUSTRY
Since the 1960’s the Food and Drug Administration has repeatedly endeavored to regulate dietary supplements out of the market. With the adoption of costly new process controls (current good manufacturing practice regulations) regulating every aspect of supplement production and the recent passage of the Food Safety Modernization Act, FDA is poised to cull from the industry 20 to 30% of existing companies, force a rise in supplement prices, and eliminate from the market most, if not all, herbal supplements. The regulators’ decades old dream of ridding the market of supplements and leaving the field to FDA approved drugs is closer now to realization than ever before. The combination of aggressive regulation, an anemic industry in an economic downturn, Congressional encouragement, and less public angst against regulatory excesses by the agency has permitted the agency to place its enforcement knife next to the supplement industry’s jugular. Will the public awaken to the threat and compel FDA to back down, or will the agency succeed in driving from the market all manner of safe supplement products to the detriment of the consuming public?
Before 1962, FDA regulated drug safety but not drug efficacy. Then in 1961 thousands of deformed newborns began appearing across Europe—victims of the sedative thalidomide. Although existing law included safety reviews that would presumably prevent the sale of thalidomide in the United States, FDA, the pharmaceutical industry, and a sympathetic Congress argued for expanded FDA powers based on the thalidomide catastrophe. The Kefauver-Harris Drug Amendments became law in 1962. Under the 1938 Act, new drug applications were automatically approved unless FDA acted to deny them. Under the 1962 Act, new drug applications were denied unless FDA acted to approve them. For a new drug application to be granted, FDA had to conclude that the new drug was safe and effective. The new law was a bi-product of drug industry/government collusion, causing its safety and efficacy reviews to lack real teeth. The FDA would defer to the drug industry’s own testing on the questions of safety and efficacy, never testing drug agents on its own. If a drug company did not identify a safety problem, the agency presumed it not to exist. From the start of the Kefauver-Harris Drug regulatory regime, the drug industry carried great clout within the agency. That clout grew over the years, to the point where within the agency political managers overseeing FDA career scientists referred to drug applicants as FDA “clients” and drug approval rates and speed of approvals became ever greater. Before 1995, FDA approved sixty percent of all new drug applications. By the end of that decade and to the present, the agency has approved over eighty percent of all new drug applications.
The same year that FDA acquired vast new powers to regulate drugs, it tried to expand its drug regulation to eliminate a burgeoning new source of competition for drugs, dietary supplements. Evidence began to reveal that dietary ingredients had therapeutic effects. The far sighted in the pharmaceutical industry and at the FDA perceived a competitive threat emerging to drug regulation from the sale of dietary ingredients at above RDA dose levels. To counter that threat, and without the slightest grant of legislative authority from Congress, the FDA published regulations setting minimum and maximum potency levels for supplements. The regulations were withdrawn in the face of enormous public protest.
Four years later, FDA returned to the task of trying to rid the market of dietary supplements. Again without any grant of legislative authority, FDA published a rule that any dietary supplement exceeding 150% of the RDA for a vitamin or mineral would automatically be regulated as a drug. Once declared a drug, the supplement could not be lawfully marketed in the United States without FDA drug approval. The dietary supplement industry challenged the rule in federal court with mixed results. Public outcry against the rule reached a fever pitch. On April 22, 1976, after intense public lobbying against the rule, Senator William Proxmire introduced an amendment to the Heart and Lung Act and the amended Act became law. It prohibited FDA from classifying a vitamin or a mineral as a drug based on its potency.
Undaunted, FDA tried yet again in the 1970’s to rid the market of vitamins by claiming on a case by case basis that they were adulterated based on their potency. The federal courts refused to cooperate with this attempt at an end-run around the Proxmire Amendment. FDA tried another approach in the 1970’s. It declared supplements to be unapproved Food Additives. Under the Food Additives provision of the FDCA, no food additive may be sold unless the manufacturer proves it safe to FDA’s satisfaction. In this way, FDA planned to make proving the safety of supplements so difficult that it would drive them out of the market. FDA’s position was a logical absurdity: Single ingredient dietary supplements were food additives because the ingredients were added to a gelatin capsule which was, FDA said with a wink and a smirk, a food. The federal courts rejected this effort. The United States Court of Appeals for the First Circuit described FDA’s approach as “nonsensical.” The United States Court of Appeals for the Seventh Circuit described the action as an “Alice in Wonderland” approach.
Then in 1980, FDA was back at it. This time FDA issued a proposed over-the-counter drug monograph for vitamins and minerals, declaring potencies above the RDA to fall within the scope of the monograph. Substantial public opposition killed this proposal.
With the arrival of Dr. David Kessler at the FDA another effort was undertaken to remove dietary supplement products from the market. Kessler endeavored to declare categories of supplements unsafe and to convince Congress of the need for more aggressive action. As part of his initiative against supplements, Kessler had FDA field agents go to health food stores across the United States, posing as customers. The agents endeavored to induce clerks in the stores to make prohibited nutrient-disease claims for supplement products. With that survey evidence in hand, Kessler testified to Congress that the retail outlets were a market of fraud and abuse deserving a crackdown. In the process of trying to prove the industry rife with those who broke the law, Commissioner Kessler neglected to abide by the law himself. He unlawfully appropriated regulatory enforcement funds for use in this unauthorized survey. Moreover, as specific Senators discovered many of the representations were factually erroneous or were fabricated. The combination of the two factors led those Senators to refer the matter to the Department of Justice for investigation and possible prosecution but nothing came of that referral.
With the Obama election sweep enabling the Democrats to take control of the White House, the House of Representatives, and the Senate, regulators within FDA (long awaiting a chance to revivify efforts to remove supplements from the market) had their green light. Leading companies in the supplement industry and their lawyers in the trade association National Nutritional Foods Association (NNFA, since renamed the Natural Products Association (NPA)) miscalculated. They assumed that if they asked FDA to impose extensive process control regulations on their own industry (creating manufacturing practice guidelines that could deem a product adulterated for record-keeping violations even if the finished product were entirely safe to consume), they could so increase the cost of daily operations as to drive from the market small and medium sized companies, an anti-competitive winfall for the larger supplement manufacturers and distributors. They went to the FDA with a proposal for extensive process controls, the agency gladly received the proposal and then promptly offered a rule in the federal register that gave FDA even more discretion to remove products from the market than the industry sought. Indeed, certain companies that advocated the regulations were shocked by the miscalculation and opposed the rule they initially endorsed.
Feeling their oats, industry leaders and lawyers thought they possessed sufficient clout to induce FDA to use the regulations to reduce the size of the industry in ways that favored market leaders. The result, however, was far from expected. The drug industry, not the supplement industry, was the controlling force at FDA. Consequently, the FDA used the opportunity to adopt rules that, by the agency’s own admission in the rule, would likely reduce the size of the supplement market by some 25%, increase the cost of supplements, and decrease the variety of them. The changes, in fact, benefited the drug industry most, not simply from a reduction in the competition for health benefit claims in the market but from the opportunity it gave the drug industry to move into the supplement industry and produce the kinds of large-scale, standardized supplement products that the FDA regulations favor.
Then in 2010, Congress passed the Food Safety Modernization Act. Suddenly every food and dietary supplement company in the United States became subject to FDA licensure. No such company may now lawfully operate unless it is registered with the FDA. The FSMA permits FDA to suspend the registration if adulteration is reasonably suspected by the FDA Commissioner, inviting abusive use of that power. It also requires those who experience a registration suspension or revocation to pursue redress through the FDA rather than in a court. Administrative hearings are notorious for their failure to protect the rights of the accused. The agency that accuses is also the agency that tries the accused, and a fair trial is likely impossible.
The FSMA permits FDA to create new standards for food safety, “science-based minimum standards,” that can enable the agency to impose new strictures that exclude products long consumed safely. The FSMA requires that FDA hire an army of new inspectors (4,000 new ones in 2011; 4,200 in 2012; 4,600 in 2013; and 5,000 in 2014). It also permits FDA to charge food and supplement companies for every reinspection of a facility, thus creating an incentive for the agency to find errors in initial inspection. That incentive is increased because the money collected from reinspection fees is dedicated to pay for inspectors. FDA expects to generate approximately $100 million in revenue from fees collected under the authority of the FSMA. Those costs will increase food prices and burdens on an already depressed market.
Although in prior years public outcry helped stem the move by FDA to eliminate dietary supplements from the market, that outcry has not reached a fever pitch in response to the latest round of regulatory efforts. That may be because the efforts come under a more palatable public interest coating. The argument that consumers must be protected from potentially unsafe products by permitting FDA to run out of existence those companies it thinks may threaten public health is far more acceptable to the public than the argument that supplements in general should be removed from the market. The lesson regulators have learned, slowly at the FDA, is that the public seems willing to permit all manner of abuse in the name of public safety, even when regulations said to be for safety focus on process controls, record keeping, etc., rather than on proving finished products unsafe to consume.
Without the public outcry against these abuses of power, the FDA proceeds now at a feverish pace, inspecting facility after facility, citing them, and then driving them out of business if costly compliance actions are not taken promptly. Repeatedly as the cGMPs and the FSMA requirements are imposed, company after company incapable of affording the cost will disappear.
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Among them will be a large number that have historically manufactured safe food products and for which there is no evidence that their finished products are unsafe. Consumer choice will be sacrificed, as will innovation and speech concerning the potential of nutrients to enhance health. The FDA is determined to make itself a barrier between the consuming public and the food industry, expanding its sovereignty at the expense of freedom of informed choice.
� 2011 Jonathan W. Emord - All Rights Reserved
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