The definition of dietary supplement as outlined in DSHEA is complex, but gave the product category firm standing to thrive in the U.S. market.

Sandy Almendarez, VP of Content

December 18, 2014

2 Min Read
Defining Dietary Supplement Gave Product Category Space to Grow

Before the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted 20 years ago, the U.S. supplement industry was homeless. It didn’t have legal footing in the market, and companies selling ingredients to bolster dietary intake could rarely defend itself if FDA determined their products were food additives without GRAS (generally recognized as safe) designation.

“The regulatory definition of a dietary supplement in DSHEA enabled the federal government to create and implement specific regulations to ensure consumer safety for this unique class of goods," said Michael McGuffin, president, American Herbal Products Association (AHPA).

Scott Bass, partner, Sidley Austin LLP, who was the principle drafter of DSHEA for the supplement industry, said the industry had three major goals for the definition of dietary supplement:

1)      Include herbs

2)      Explicitly say dietary supplements were not food additives

3)      Account for non-vitamin and -mineral substances, such as CoQ10

Some compounds have been questioned, such as probiotics and synthetic botanicals, as being part of the definition of dietary supplement. The two compounds were called out in FDA’s July 2011 draft guidance for new dietary ingredient (NDI) notifications, with the agency questioning their ingredient status.

Per DHSEA, supplements must be digested; however, some products with alternative ingestion pathways, such as inhaling or topically applied, have marketed themselves as supplements. And FDA has warned them accordingly.

Also per DSHEA, supplements are not foods, which seems pretty clear until innovative supplement manufacturers look to meet consumer demand for new ways to ingest supplement ingredients. Sometimes, these products flirt with the properties of foods.

In January 2014, FDA published a final guidance on distinguishing liquid dietary supplements from conventional beverages. “That document is very noteworthy because for the first time, FDA formalized its thinking on how it is interpreting the provision in the definition of ‘dietary supplement’ that a supplement cannot be ‘represented for use as a conventional food,’" Wasserman said.

It’s clear from the definition of dietary supplement that a supplement is not a drug, but it wasn’t so clear before the passage of DSHEA in 1994. Now, it’s easy to take advantage of the fact that the supplement industry has a home in the U.S. regulatory landscape. Herbs are supplements and so are other nutrients, even if they don’t carry an approved RDA.

Read the full article “Defining ‘Dietary Supplement’" in INSIDER’s Regulatory Content Library.

About the Author(s)

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

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