Do transparency, integrity and quality make up a level supply-chain playing field for all suppliers and manufacturers or are these essential requirements a minefield of more questions than answers?
Here is a continuation of the article from the print edition.
The participants are:
Cal Bewicke, Chief Executive Officer, Ethical Naturals, San Anselmo, CA
Shaheen Majeed, Marketing Director, Sabinsa, East Windsor, NJ
Michael McGuffin, President, American Herbal Products Association (AHPA), Silver Spring, MD
Steve Mister, President and Chief Executive Officer, Council for Responsible Nutrition (CRN), Washington, D.C.
Alison Raban, Certified Food Scientist, BI Nutraceuticals, Rancho Dominguez, CA
Jarrow Rogovin, Founder and President, Jarrow Formulas, Los Angeles, CA
NIE: As mentioned, New York State is at it again. Proposed Assembly Bill (AB) 4712 would create an onerous state regulation and impose financial penalties for health-food stores selling any product containing creatine monohydrate and would force products containing creatine to behind-the-counter. Not only that, it would carry a civil penalty of up to $500 per violation for any retailer selling to a customer under the age of 18.
Aren’t New York legislators unfairly targeting products that have been widely studied and deemed safe for decades. Isn’t it true that civil penalty threat to retailers is a revenue generating, money-grab proposal by the state legislature? Aside from putting out fires like this when they come out, how can we be more proactive with goo-goo states like New York and California in communicating the safety story of dietary supplements?
Rogovin: It is interesting that these teenagers can be trusted to handle a potentially dangerous piece of equipment—a car—but cannot be trusted to buy this supplement until the age at which they can vote.
Creatine has a very good safety record, better than that of aspirin, so why should such draconian laws be enacted, except that hardcore leftist politicians despise our industry and they are afflicted with a severe obsessive-compulsive control-freak disorder.
The industry needs to employ more active lobbyists to deal with these issues at the legislative and similar levels before they make it into the public sphere. At the moment the industry is involved in an endless litany of ‘When did you stop beating your wife’ interactions [. . .] I think there are some wrong priorities out there.”
McGuffin: AHPA and its Sports Nutrition Committee appreciate efforts to ensure sports nutrition products are safe, but this legislation is unnecessary given the general safety of creatine and creatine products.
In January 2016, AHPA and the United Natural Products Alliance (UNPA) launched a joint campaign to develop working relationships with state attorneys general (AGs) and educate them about herbal and dietary supplements to ensure they have an accurate understanding of the industry and our products.
AHPA continues to retain the services of Doug Gansler, former Maryland Attorney General and past president of the National Association of Attorneys, to deliver information and expertise about the industry to his colleagues and keep AHPA informed of actions by state AGs.
Mister: CRN is deeply concerned, not only because this legislation singles out creatine, but also because of the potential damaging effects that age restrictions have on self-selection.
Creatine has been widely studied and has a tremendous margin of safety when used by both young people and adults. In addition, age restrictions on any dietary supplements limit consumers’ ability to self-select in the aisle and discourage retailers from carrying the products all together. CRN already has an active lobbying program in Albany to oppose this legislation.
Majeed: In the last several years we have seen a sharp rise in class-action suits brought against supplement manufacturers, many of these by predatory class-action lawyers without much depth to the matter looking for a quick settlement.
The fact that legislators, media and some attorneys deem health supplements as unregulated products is problematic. We all know the laws that very clearly lay down the regulations related to the dietary supplement industry. We also know adverse-event reports show supplements to be one of the safest categories of consumer products there is.
After the New York AG’s (attorney general) action and the deluge of inaccurate media coverage it attracted, it became very obvious to major supplement business players that the industry needs to proactively give average consumers accurate information. Educational programs that provided a platform for industry to clear up the misconceptions to the general public as well as legislators were instituted by manufacturers and some publishers. These efforts helped to convey information from industry leaders involved in retail, supply chain and manufacturing on: steps taken for maintaining proper chain of custody in supply chain management; the role of quality management and how in depth quality control of supplements works in the practical world; as well as regulations which industry follows in manufacturing dietary supplements.
NIE: So the OWL (Online Wellness Library), product label database is up and running, at least in beta stage. Supporters of label registries would say that this is a perfect example of transparency that’s good for reputable companies, for consumers and for the industry as a whole. Some might say that self-regulatory initiatives like this move us too far in a hyper-regulated environment a la Health Canada. Is OWL different than the dietary supplement registry that was announced in April 2016?
Mister: For a long time, thought leaders in the industry have advocated for an industry-run initiative to help regulators gain a better understanding of the size and breadth of the industry, as well as the types of products that are on the market.
Having the industry develop and manage such a library of product labels has the added benefit of allowing the industry to maintain control of the project and forestall possible mandatory, government-mandated registration. The development of the Supplement OWL, which has been spearheaded by CRN, hopes to achieve just that. One of the benefits of the Supplement OWL is that the industry controls the registry and participation is voluntary.”
Just as it was envisioned last year, the Supplement OWL, which formally launched in April 2017, will provide visibility of product labels and information to regulators, retailers and even consumers. It is comprised of two tiers of information: Tier 1, which is free for all industry participants, delivers copies of supplement labels and basic product information, most of which is culled from the label itself. Tier 2, which is available for a small fee, allows product marketers to upload additional supporting materials and documentation that supports the quality of their products and the representations made in Tier 1.
We are hopeful that all facets of the industry will see the benefits of transparency the Supplement OWL offers and will voluntarily enter their product labels into the registry.
Majeed: OWL is definitely a welcome start, however we have to be clear in the goals it’s intended to achieve.
OWL provides a database where people can look at the supplement information provided by the manufacturer. While it may become an excellent reference source, it does not go beyond that. It’s important not to view any such program as a cure all for the range of issues that need work or a replacement for rigorously following best practices. The major issues of the adulteration or products without clinical validation, improper dosage, GMP (good manufacturing practice) irregularities, disease claims, and other ways in which some companies undermine long term sustainability of the industry cannot be answered by this database.”