Why natural nearly wasn't available
24th July 2014
By the early 1990s, around a quarter of adults were using dietary supplements. Given the claims for treatment as well as prevention of disease that were being bandied about on labels and advertising, the US Food and Drug Administration (FDA), under pressure from Big Pharma, decided it was time to crack down on the nutraceutical industry.
The Nutrition Labeling and Education Act (NLEA) of 1990, signed in by George Bush Snr, was designed to tighten up on claims for nutritional and health claims on foods and supplements. But the FDA, by treating supplement ingredients, especially herbal ones, that did not have FDA-recognised nutritional value as food additives, challenged the legality of increasing numbers of supplements. If they han’t been proved and safe and were not listed as ‘generally regarded as safe’ (GRAS), products would be deemed as adulterated and therefore illegal.
Given this perceived regulatory abuse by the FDA, the Health Freedom Act was introduced into the Senate to protect US citizens’ rights to access safe and effect dietary supplements. Owing to lobbying by pro-pharma interests, the Act never saw light of day and the FDA kept challenging dietary supplements.
With continued anti-supplement zeal, the FDA then raided the clinic of Dr Jonathan Wright, the Tahoma Clinic, in Virginia. Dr Wright was—and is—one of the most respected and pioneering integrative medicine doctors in the US. News of the Tahoma Clinic raid triggered public unrest—and in concert, a highly coordinated response from the US nutraceutical industry, health stores, movie stars and other celebrities. The letter-writing and fax campaign that was unleashed on Congress in early 1994 during the passage of the Dietary Supplement Health and Education Act (DSHEA) was unprecedented, eclipsing even that associated with opposition to the Vietnam war.
This Act, passed into law under Bill Clinton’s presidency is still enacted, and provides a distinct, regulatory carve-out for dietary supplements as a category of food. It also recognises the role of these products in reducing risks of chronic diseases. And after nearly 5 years of uncertainty, it finally provided a regulatory safe-haven from which an industry boom responding to public demand could take place, one that has only started plateauing in very recent years.