Canada continues the slide into truly Draconian tyranny. In the US, a few honest people in Congress and elsewhere have slowed the corruption over the years, but our FDA has been trying to ban supplements or make them Rx-only for decades. F'rinstance (from https://www.fdareview.org/issues/history-of-federal-regulation-1902-present/#p21 ) --
In 1973, the FDA published regulations (to take effect in 1975) expanding its control over supplements by declaring that any dietary supplement that it considered to lack nutritional usefulness was a drug and thus under the FDA’s control. High-potency vitamins, by which the FDA meant vitamins sold in dosages as little as twice the federal recommended daily allowance (RDA) for example, were ipso facto considered a drug (i.e., regardless of manufacturer claims or lack thereof). High-potency vitamins were effectively made illegal by this ruling because they could not be sold without FDA approval, and the FDA would not approve supplements that it considered to be unnecessary. Vitamin manufacturers and consumers fought back, and in response Congress passed the Proxmire Vitamin Mineral Amendment of 1976, which stated that the FDA could not classify a mineral or vitamin as a drug “solely because it exceeds the level of potency which [the FDA] determines is nutritionally rational or useful” (21 USC 350 [1994, originally enacted 1976], [a][1][B]).
It is worth pointing out explicitly, although it will come as no surprise to anyone who follows today’s health news, that numerous scientific studies have since validated many of the health claims for vitamins and minerals that the FDA had earlier suppressed. The FDA suppression of information concerning vitamin E and heart attacks, for example, may rank alongside its suppression of information concerning aspirin as one of the most deadly regulations of the post–World War II era.
In 1985, the FDA lost a related turf war with the Federal Trade Commission (FTC) and the National Institutes of Health (NIH). Under recommendation from the National Cancer Institute, a division of the NIH, the FTC permitted Kellogg to claim that a high-fiber diet reduced the probability of certain types of cancer. The FDA wanted to sue Kellogg, but the FTC argued that the ads presented “important public health recommendations in an accurate, useful, and substantiated way” (quoted in Calfee 1997, 25). Under pressure, the FDA backed down, and as a result it was established that food products could advertise a “substantiated” health claim without going through the FDA drug approval process.
Under the protection of the Proxmire Amendment, the dietary and nutritional supplement industry expanded, but the FDA stepped up enforcement again in the early 1990s after thirty-eight deaths were attributed to L-tryptophan, an amino acid widely used for treating depression and building muscle mass. (The Centers for Disease Control later exonerated L-tryptophan in the deaths, which were caused by a contaminant, but the FDA did not lift its ban on OTC sales of L-tryptophan (Beisler 2000). In 1993, the FDA announced that it planned to regulate as drugs all amino acids, herbs, and other supplements including fibers and fish oils. The FDA soon found itself under a furious attack from millions of consumers of nutritional supplements. The DSHEA, passed in 1994 and taking effect in 1996, explicitly required the FDA to revoke its Advance Notice on supplements.
Under the DSHEA, nutritional supplements can make substantiated “statements of nutritional support” that do not thereby invoke FDA control. Supplements, however, cannot make claims regarding disease without becoming regulated as drugs. The distinction between statements of nutritional support and claims regarding disease is vague. Manufacturers of St. John’s Wort, for example, may claim that St. John’s Wort “promotes healthy emotional balance and well-being,” but they cannot say St. John’s Wort “is useful in the treatment of depression.” The distinction is mostly for lawyers, not consumers, considering that many consumers do take St. John’s Wort for depression. (Such consumers are in fact justified in doing so; a number of studies indicate that not only is St. John’s Wort effective at relieving mild cases of depression [e.g., Woelk 2000], but it does so with fewer side effects than many antidepressive pharmaceuticals. In addition, St. John’s Wort is considerably cheaper than pharmaceuticals and does not require a prescription.)
Dietary supplements that make nutritional claims must carry the following two disclaimers: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” In the section Reform Options, we suggest that the first disclaimer is useful and that this split-label approach be extended to drugs proper. The second disclaimer is not informative.
Subject to certain conditions, such as that the information presented is not false or misleading and not biased in favor of a particular manufacturer or brand, the DSHEA also restricts the FDA’s ability to ban the dissemination of information on dietary supplements (Pinco and Rubin 1996). Health food retailers, for example, can now market books, magazines, and scientific articles describing the uses of dietary supplements. As a result, in recent years consumers have become much better informed about the role of vitamins and other supplements in optimal health.
Canada continues the slide into truly Draconian tyranny. In the US, a few honest people in Congress and elsewhere have slowed the corruption over the years, but our FDA has been trying to ban supplements or make them Rx-only for decades. F'rinstance (from https://www.fdareview.org/issues/history-of-federal-regulation-1902-present/#p21 ) --