Special Edition: Transparency in Dietary Supplements

Efforts by AHPA, BAPP pull back veil on issues relating to identity, adulteration

By Hank Schultz

- Last updated on GMT

Efforts by AHPA, BAPP pull back veil on issues relating to identity, adulteration
Efforts by two major groups in the botanical trade are boosting transparency relating to the identity and purity of these ingredients.

One of the issues that has swirled around botanical ingredients is one of nomenclature.  This might seem a dry, academic exercise at first, harking back to the foundations of classification with Linnaeus.

But it actually drives at the foundations of transparency.  Only by calling things by their right names can companies begin the process of assuring their customers and consumers that what’s on the bill of lading and what’s on the label is the real thing.

Many years, many names

The use of botanical ingredients can be traced back thousands of years.  And the names for many of these substances can be traced back almost as far. Through these mists of history the issue has emerged that the same species can be found under different common names depending on what culture you’re dealing with.  Or one common name might apply to multiple species.

Dietary supplements didn’t fit into a convenient regulatory category, so the Dietary Supplement Health and Education Act (DSHEA) created one for them in 1994. One of the big ways in which botanical ingredients didn’t fit was in the polyglot nature of their nomenclature.  Drugs go by development designations and then trademarked names after they are approved.  Botanical ingredients, on the other hand, can go by many aliases.

The American Herbal Products Association has wrestled with this issue since before the passage of DSHEA.  In 1992 AHPA published its first edition of Herbs of Commerce​. It has been formally recognized by FDA as an authoritative reference.

800 additions for new edition

The book was updated in 2002 and AHPA is now working on the third edition. The current edition of Herbs of Commerce​ lists Latin binomials, Standardized Common Names, Ayurvedic, Chinese (pinyin), and other common names for 2,048 species, including 25 fungi and 23 seaweeds.  AHPA says it is currently considering about 800 additional entries suggested by industry stakeholders.

After review by an expert panel, the entries will be submitted to AHPA members for their input. 

“Nomenclature is not the sexiest topic, but it is important,” ​said AHPA chief science officer Holly Johnson. “Words are important. What you put on your label matters.”

“We have heard orally from FDA that while the first edition of ​HoC is what is written into the regulation, if a company is following ​HoC 2 for their ingredient designations, they would accept that as authoritative.  What we have heard is that FDA will wait until we publish ​HoC 3 to update the regulation,” ​she said.

Joint effort sheds light on adulteration

Another effort to boost transparency in the botanical end of the dietary supplement industry deals with the skeleton in the closet: adulteration.

The Botanical Adulterants Prevention Program has published more than 50 communications dealing with issue.  They include bulletins, full reports and lab guidance documents. 

The program is managed by the American Botanical Council. It counts the American Herbal Pharmacopoeia and the National Center for Natural Products Research as partners. 

ABC chief scientific officer Stefan Gafner, PhD, heads the peer review and publication process for the program.  It has more than doubled in size since he came on board.

Gafner said the program was at first viewed with suspicion within the industry.  Dirty laundry should be dealt with behind closed doors, so to speak.

“I believe in the beginning people feared that a lot of what we do could be picked up by the mainstream media and could be blown out of proportion.  I don’t think that as happened.  And I think that may have given a higher level of comfort with the program,”​ Gafner told NutraIngredients-USA.

Gafner said BAPP has had a positive effect on the industry, especially after the name was change (the word “prevention” was added).

“We get more questions from members now about identity issues.  They are wondering, how can I be sure I have the right species?  And they are sharing the data about solving those questions.  I think that’s something that goes a long way toward supporting transparency,”​ he said.

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