Dietary supplements, drugs and DSHEA

 
 
 

If, like millions of other Americans, you take a multivitamin, herbal supplement or omega-3 fatty acid (such as fish oil), you rely on dietary supplements to support your health. Dietary supplements are an important industry in Utah. An estimated 50,000 Utahns work for dietary supplement manufacturers or related companies. By one measure, dietary supplements are the third-largest industry in Utah by workforce size, behind only tourism and tech.

Dietary supplements are products designed to improve health but are not specifically intended to treat or prevent disease. That’s what sets dietary supplements apart from drugs, which must undergo a more rigorous and expensive regulatory review process by the Food and Drug Administration.

Regulation of dietary supplements is governed by the Dietary Supplement Health and Education Act, or DSHEA. Passed in 1994, DSHEA has been critical to the rise and continued success of Utah’s dietary supplement industry. DSHEA establishes various requirements for dietary supplements, especially related to labeling. For example, packaging must include nutrition information, a full list of ingredients and any important safety details. However, since dietary supplements are not meant to treat or prevent disease, they are not subject to the same clinical study and FDA approval requirements as drugs.

The difference between dietary supplements and drugs
This difference in regulatory treatment makes sense given the significant differences between dietary supplements and drugs. A multivitamin designed to ensure you receive essential vitamins and minerals for the day is very different from a complex chemical compound designed to treat a specific disease, such as diabetes or rheumatoid arthritis. Clinical trials are necessary to determine a drug’s efficacy in treating a particular condition. They are also essential to understanding a drug’s side effects. Dietary supplements, by contrast, are not targeted at treating any particular disease. And, as combinations of naturally occurring ingredients, they are also much less likely to cause unexpected side effects.

The difference in regulatory treatment between dietary supplements and drugs also makes it critically important to preserve the boundaries between the two. If regulators mistakenly start treating dietary supplements like drugs and impose clinical efficacy and safety requirements, they could effectively destroy the market for many products — from herbal supplements to fish oil — that are naturally occurring and provide significant benefits to people of all ages.

Conversely, if regulators were to start allowing companies to market drugs as dietary supplements, and thus bypass the required efficacy and safety showings, the result would be a flood of new products that not only might fail to deliver their claimed health benefits but also might have dangerous, unknown side effects. That’s why Congress — led by Sen. Orrin Hatch, DSHEA’s sponsor — set clear limitations in DSHEA on when an ingredient can be properly marketed as a dietary supplement.

DSHEA’s drug exclusion clause
One important statutory limitation on when an ingredient may not be marketed as a dietary supplement is DSHEA’s drug exclusion clause. That clause provides that an ingredient is not a dietary supplement if the FDA has authorized it for investigation as a new drug, if substantial clinical investigations have begun and if those investigations have been made public. This rule ensures that dietary supplement manufacturers are not able to undercut drug manufacturers by marketing products that have been investigated or approved as drugs and therefore should be classified as drugs — especially when drug companies have already invested in extensive clinical trials and complied with additional regulatory and safety requirements. At the same time, it preserves a pathway to market for dietary ingredients that were marketed as dietary supplements before they were investigated or approved as drugs.

Specifically, the drug exclusion clause includes a “first to market” provision that creates an exception for ingredients that were marketed as dietary supplements before they were authorized for investigation as new drugs. This provision offers similar protection against drug manufacturers attempting to undercut dietary supplement manufacturers by requesting the FDA to reclassify ingredients that have historically been treated as dietary supplements as drugs. It also ensures that a drug manufacturer’s decision to seek approval of a product as a drug does not cut off a dietary supplement manufacturer from continuing to market that same product as a supplement. In this way, it protects dietary supplement manufacturers from potential gamesmanship by drug manufacturers.

How DSHEA ensures consumer safety
DSHEA struck a careful balance between providing easy, affordable access to dietary supplements and maintaining important safety and efficacy standards for drugs. It reflected Congress’s determination that multivitamins, herbal supplements and similar products should be widely available and that regulatory hurdles for these products should be minimal. That determination remains as valid today as it was in 1994 when Sen. Hatch led the passage of DSHEA. Equally valid were the rules Congress established to ensure that products classified as drugs are properly regulated as drugs.

DSHEA has played a vital role in the success of Utah’s dietary supplement industry. Hundreds of Utah businesses and tens of thousands of Utah workers — to say nothing of the hundreds of thousands of Utah consumers who regularly take dietary supplements — have benefited from the carefully calibrated regulatory regime the law created.

As with all legislation, DSHEA could undoubtedly be improved, and measures to do so deserve careful consideration. However, the core principle behind the law — that dietary supplements should be treated differently than drugs — remains intact. That principle runs both ways: dietary supplements should not be treated as drugs, and drugs should not be treated as dietary supplements.

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Matt is the executive director of the Orrin G. Hatch Foundation. A 15-year veteran of Capitol Hill, he served as senior counsel on the Senate Judiciary Committee and as Senator Hatch’s chief of staff.

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