HerbalEGram: Volume 7, Number 1, January 2010

Industry Response to Initiative for Increased Dietary Supplement Regulation


In December of 2009, the US Anti Doping Agency (USADA) formed Supplement Safety Now (SSN), an initiative urging Congress to establish regulations that ensure all supplements sold in retail stores and online are safe and effective and that the relevant federal agencies have sufficient tools to do so.1 

USADA created SSN in partnership with the National Football League (NFL), Major League Baseball (MLB), National Basketball Association (NBA), National Hockey League (NHL), US Olympic Committee, and other sports organizations. The initiative states that most dietary supplements are made by responsible manufacturers but current laws make it too easy for the growing number of supplement products containing dangerous and undisclosed ingredients to make it to market.

SSN’s launch follows the September 2009 US Senate Judiciary Subcommittee on Crime and Drugs titled “Body Building Products and Hidden Steroids: Enforcement Barriers.” The hearing came after reports of several national sports team players who tested positive for banned substances allegedly after they took products marketed as “dietary supplements.”2 

The SSN platform includes the following pre- and post-market proposals:3

  • Dietary supplement companies should:
    • register as dietary supplement companies;
    • provide the US Food and Drug Administration (FDA) with a comprehensive list of all dietary supplements manufactured, including a copy of the master formulas and product labels;
    • provide a 75-day pre-market notice to FDA for the introduction of New Dietary Ingredients (NDIs, now required by the Dietary Supplement Health and Education Act of 1994 [DSHEA]), as well as all products containing steroids (including hormones, pro-hormones and hormone analogues), and establish that the product is safe under its intended use;
    • maintain a substantiation file for statements of nutritional support (including so-called “structure/function” claims) that is available on request to the FDA;
    • report all adverse events, not just those that are serious (as is currently required by federal law);
    • “be prohibited from advertising that any product performs like a steroid, is named similarly to a steroid, affects the structure of the body or touts the fact that a product may soon be declared illegal.”3
    • Distributors and retailers of dietary supplements should obtain evidence of compliance from the manufacturers and licensors that all pre-market requirements have been complied with or bear responsibility for the products they sell.
    • FDA should be given the power to unilaterally prohibit sales and initiate immediate recall of any product that has not followed all pre-market requirements or when FDA determines that there is a reasonable probability that the product poses a safety risk or contains an ingredient that will ultimately be scheduled as a controlled substance.
    • The US Drug Enforcement Agency (DEA) should be given emergency scheduling power for steroids and the criteria for scheduling steroids under Schedule III of the Controlled Substances Act (CSA) should be modified to better address the current reality of designer steroids.
    • Congress should amend Section 102 of the CSA to schedule the 20 or more designer steroids that have been identified but not yet scheduled as controlled substances.

The dietary supplements industry immediately commented on the SSN campaign. President and CEO of the Council for Responsible Nutrition (CRN), Steve Mister, said that CRN agrees with SSN’s concerns with dishonest companies that sell illegal products labeled as dietary supplements.4 “We strongly encourage regulatory agencies to continue to take the enforcement actions available to them under the law, including criminal sanctions, against these companies,” said Mister, adding that CRN is willing to partner with USADA and the other agencies involved on the points on which they agree.
 
He further noted that CRN supports some of SSN’s proposals that would enhance the current laws, such as giving FDA and the Drug Enforcement Administration (DEA) more resources, having FDA clarify the process for New Dietary Ingredient (NDI) notification, and FDA enforcement to penalize those who do not submit NDI notifications.

Mister went on to say that the current regulatory framework, such as NDI notifications and current Good Manufacturing Practices (GMPs), is more than adequate to ensure that supplements are safe—if the laws are enforced correctly. And regulatory agencies need more resources in order to do this, he continued. Additionally, while some of SSN’s initiatives are “well-intended,” they might not be feasible or effective, he said. For example, CRN supports SSN’s proposal for an FDA registry of products, but thinks that illegally-operating companies, the alleged cause of the problem, would not register.
  
The Natural Products Association (NPA) also published a response, in which its Executive Director and CEO, John Gay, said that consumers should still feel safe when taking supplements.5 Existing regulations work to ensure that products meet purity and quality standards and have no contaminants, said Gay.

Gay recognized that there are some “bad actors” in the industry that endanger public health and said that NPA appreciates USADA for focusing on these companies. But “simply putting more laws on the books for the bad guys to continue to ignore is not the answer,” said Gay. “When laws are being broken, as they are in this case, the solution is to put more cops on the street by increasing the resources available to federal regulators to allow them to fully – and effectively – enforce the existing laws.” This would be much more effective than writing and trying to pass new legislation for regulations that might not be enforced properly, he added.
 
NSF International, a nonprofit public health and safety organization that certifies dietary supplements for their quality and production according to GMPs, issued a statement in “full support” of SSN.6 According to NSF, the SSN campaign will help protect customers from ingesting steroids or other illegal or controlled substances in products marketed as dietary supplements. “These dangerous and illegal products pose a significant public health risk and more stringent enforcement and independent surveillance is needed to better safeguard consumers,” said Lori Bestervelt, NSF’s senior vice president and chief scientific officer. NSF called for testing and certifying dietary supplements and nutritional products to prevent contaminated products from being sold as dietary supplements.

NSF has partnered with sporting organizations, such as the NFL and MLB, since 2004 to test, certify, and ensure that dietary supplements are free of banned substances. Its dietary supplement certification program tests products for contaminants and heavy metals, verifies that label ingredients are consistent with the ingredients in the product, and audits manufacturing facilities to ensure they operate under the GMPs.
 
Two days after SSN was launched and industry responded, the DEA classified boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione as anabolic steroids under CSA.7 The final rule goes into effect on January 4, 2010. NPA welcomed the classifications, saying they are an example of how federal regulators can exercise their existing authority to prevent dietary supplements from being tainted with scheduled substances.

More information on SSN is available on its website.


—Lindsay Stafford


References

1. Our mission. Supplement Safety Now website. Available at: http://www.supplementsafetynow.com/about-us/our-mission.aspx. Accessed December 4, 2009.

2. Body Building Products and Hidden Steroids: Enforcement Barriers. Hearing before the Subcommittee on Crime and Drugs of the Senate Judiciary Committee. 111th Cong, 1st Sess (September 29, 2009).  

3. Our position. Supplement Safety NOW website. Available at: http://supplementsafetynow.com/issue-need/our-position.aspx. Accessed December 14, 2009.

4. CRN responds to “Supplement Safety NOW” initiative [press release]. Washington, DC: Council for Responsible Nutrition; December 2, 2009.

5. Statement by John Gay, executive director and CEO, Natural Products Association [press release]. Washington, DC: Natural Products Association; December 2, 2009.

6. NSF International Certified for Sport™ program announces support for USADA’s “Supplement Safety Now” campaign and increased enforcement to safeguard against dangerous products containing steroids [press release]. Ann Arbor, MI: NSF International; December 2, 2009.  

7. Natural Products Association issues statement on DEA's steroid classification action [press release]. Washington, DC: Natural Products Association; December 4, 2009.