Marketing Dietary Supplements — A Brief Discussion of Current Regulatory Challenges

herbal dietary supplements

At the federal level, dietary supplements and ingredients are regulated by the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); at the state level, all 50 states have agencies in charge of consumer-health and food product oversight.  

Regarding dietary supplements, the FDA has responsibility for oversight of “claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale.” It is the FTC that has “primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials” (1). 

The Health Claims Conundrum 

In 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA), which was intended to improve nutritional information regarding health claims made for products. The NLEA provides for mandatory nutrition labeling for most food products intended for human consumption and offered for sale (2).  

The NLEA also gives the FDA wide authority over health claims by establishing detailed requirements regarding the types of claims that food labels can contain and the process that the agency should use for regulating these claims.  

Unfortunately, the consensus is that unqualified health claims (or nutrient-disease risk reduction claims) are nearly impossible to obtain and qualified health claims are (a) very difficult and expensive to obtain, and (b) usually, when rarely successful, granted with qualifiers that render the claim, according to many experts, almost worthless.

Some industry observers dispute the FDA’s position that a consensus of scientific agreement is needed for a claim to be made. As Jonathan Emord notes in The Rise of Tyranny (3), nutrition science is almost never proven to a conclusive degree. Scientists rarely agree with complete unanimity, but that does not mean that “emerging science has no value to consumers” or that an accurate representation of existing science, albeit not 100% conclusive, cannot reasonably be made. 

Along with existing restrictions on what can be included in product labeling, some also believe that the confusing requirements regarding the provision and placement of third-party information (including studies) make it very difficult for any manufacturer (especially a branded ingredient supplier) to properly associate scientific information with a branded ingredient or a flagship ingredient in a finished product—which, some say, suppresses the dissemination of accurate descriptions of product-related science in the market. 

This, Emord suggests, makes the consumer selection process more arbitrary and haphazard and may make these products more vulnerable, not less, to fraud. As Emord notes: “If I am kept in the dark about a commercial good having potential beneficial properties not visible to the naked eye, I am more apt to believe false claims of hucksters than if I am ordinarily presented” with accurate science-backed information at the point of sale (3).  

In the preamble to an interview with Jonathan Emord in WholeFoods Magazine, Dr. Richard Passwater, put it this way: “You are prohibited from telling customers about scientific truths concerning any relationship between a nutrient and a disease. The FDA prevents this dissemination of truth under the cloak of FDA’s arbitrary definition that they are no longer nutrients, but rather illegal, unproven drug products if you mention a disease” (4). 

DSHEA and Structure-Function Claims in Perspective 

On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was passed unanimously by the House of Representatives and the Senate.

DSHEA represented Congress’s efforts to enhance public access to and information about safe dietary supplement products and to create a “rational Federal framework” for supplement regulation to replace “the current ad hoc, patchwork regulatory policy” (2).

DHSEA added section 403(r)(6) to the FD&C Act, which allows for the use of—and post-market notification regarding—structure-function claims that (a) meet certain requirements, (b) are truthful and non-misleading, and (c) include the standard FDA disclaimer: “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.”

Then, in 1997, Congress included in the Food and Drug Modernization Act (FDMA) a provision allowing dietary supplements to make health claims. Shortly after this, the FDA attempted to classify normal states and stages as pregnancy, aging and menopause as “diseases,” an effort that was opposed and not implemented. 

Regarding structure-function claims, industry criticism about what’s allowable for claims includes concerns that the language industry is left with is so vague that consumers can have a hard time determining if a given product can support their specific health need.

Some suggest that the FDA continues to re-interpret the plain meaning of DSHEA regarding what are structure-function claims and what are not, often finding fault with support claims by suggesting that they represent implied disease claims.  

In addition, the FDA does not explicitly approve structure-function claims that are sent in as 403(r)(6) post-market notifications; it just either objects to them or does not object. If a manufacturer sends in five claims and one is objected to, the company then proceeds with the four that did not receive objections. However, if the company never receives a response, are they to assume there was no objection, or are they to assume the response is delayed due to ever-increasing FDA backlogs? This is not a rational process, according to some. 

In 1999 testimony before the House Committee on Government Reform, Dr. Annette Dickinson, representing the Council for Responsible Nutrition (CRN), said: “Beyond that, the act clearly anticipates that any statement that, on its face, is a statement about affecting structure and function should be permitted under DSHEA. Once FDA leaves that solid ground and launches off into trying to draw another line between statements of nutritional support that may be implied disease claims and statements that may not, we believe they enter an area where there really is no logical line that can be drawn” (5).

Where Does This Leave Science-Backed Ingredients and Products? 

With these regulations and restrictions that are in place, manufacturers of branded ingredients are limited as to what can (a) get into the consumers hands and (b) be associated with a finished product. 

For example, AHCC® is a unique, natural-cultured mushroom mycelia extract derived from the cell wall of the mycelia (roots) of lentinula edodes mushrooms. AHCC is manufactured through a patented, extended liquid culturing process that makes its active components different from other mushroom extract products.  

While most medicinal mushroom extracts have a molecular weight of more than 200,000 daltons, the presence of acylated alpha glucans with a molecular weight of around 5,000 daltons is considered one of the attributes of organic AHCC that provides it with a high level of absorption and validated clinical efficacy. 

A complex molecule rich in alpha-glucans, as noted, and other immune-modulating polysaccharides, AHCC is supported by 20 human clinical studies (6), by over 30 papers published in PubMed-indexed journals and by more than 100 pre-clinical and in vitro studies (7). In fact, the most recent study published in Frontiers in Oncology demonstrates AHCC’s efficacy in fighting high-risk HPV infection (8).

This brings us back to the question: How can sufficient science-backed information about ingredients or ingredient complexes—in this case AHCC—get in the hands of consumers, healthcare practitioners, retailers, and the media? That’s why the AHCC Association (ahcc.net) was created. 

The AHCC Association Emerges 

Its members commit to maintaining AHCC product integrity and efficacy. They work together through educational initiatives in order to build long-term demand. The association’s goals are to: 

  • Provide a united voice for the AHCC category. 
  • Protect the category from those that who would willfully or unknowingly exploit it through poor quality or adulterated products. 
  • Proactively work with media, regulators, practitioners, and other professionals and, ultimately, consumers to promote growth and science within the category. 

While efforts in support of disseminating the science behind AHCC are noteworthy, there remain a number of challenges that industry at large needs to overcome in order to (a) build a body of reputable human clinical data and (b) find compliant ways of getting the information out to all of the right target audiences. 

References

  1. Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry. April 2001. Available at: https://www.ftc.gov/business-guidance/resources/dietary-supplements-advertising-guide-industry 
  2. Mueller E. A Structure That Does Not Function: An Examination of the History and Current Regulatory Status of Dietary Supplements and Their Label Claims. April 30, 2001. Harvard Library. Available at: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852214 
  3. Emord J. The Rise of Tyranny: How Federal Agencies Abuse Power and Pose Risks to Your Life and Liberty. September 1, 2008.  
  4. Passwater R. The Rise of Tyranny [Vitamin Connection]. Interview with Jonathan Emord. Whole Foods. October 1, 2008. Available at: https://wholefoodsmagazine.com/columns/vitamin-connection/rise-tyranny/ 
  5. Dickinson A. Testimony before the House Committee on Government Reform. U.S. Government Printing Office. March 25, 1999. Available at: https://www.govinfo.gov/content/pkg/CHRG-106hhrg57333/html/CHRG-106hhrg57333.htm 
  6. AHCC Association. Human Clinical Studies. Available at: https://www.ahcc.net/human-clinical-studies/ 
  7. AHCC Association. Pre Clinical and In Vitro Studies. Available at: https://www.ahcc.net/pre-clinical-in-vitro-studies/ 
  8. Smith JA, Gaikwad AA, Mathew L, et al. AHCC® Supplementation to support immune function to clear persistent human papillomavirus infections. Front Oncol. 2022 Jun 22;12:881902. doi: 10.3389/fonc.2022.881902. 

This content is paid for and provided by the AHCC Association.