By Len Monheit
At this time last year, industry had just been informed of FDA's intention to ban ephedra. Over the past twelve months, in what we knew would be a critical year both from a regulatory and legislative standpoint, industry around the world has watched Codex language regarding food supplements evolve to its final stages, new regulations emerge in Canada, countries in the Pan-Pacific region organize and commit to export markets, but also tighten internal regulations as internal nutritional supplement markets emerge and thrive.
An industry top ten list would be hard to generate, and would probably be skewed significantly by recent events. Actually, it would probably due better justice to generate a top ten list in every category, from regulatory to business to science to products, but other venues do some or all of that quite well.
So following, and in no particular order, are some of the most important developments of 2004, largely due to a potential impact on the year to come. My crystal ball is a bit rusty, so I'd also like to encourage everyone to consider their own comments and wish list for 2005 too. To submit your comments for posting, anonymously or with name, click here.
One cannot consider a 2004 retrospective without noting the activities of the regulatory agencies, specifically FDA and FTC in the United States. From the announced ephedra ban, to its imposition and the use, for the first time, of risk/benefit criteria, this action and the fallout triggered heaps of media coverage and expressions of concern over ingredient safety and industry responsibility, which, in turn, turned up the volume for a Mandatory Adverse Event Reporting Mechanism, culminating in the agreement between Senator's Durbin and Hatch to work together (with input from industry) into such a system. Out of the ephedra 'issue' also arose concerns about other stimulant acting products, especially on the ingredient side, which can be traced almost directly to the late year focus by FDA on revisiting the criteria and process for documenting and accepting New Dietary Ingredients to the marketplace. (I realize that this is a very simplified cause and effect argument and that the reality is more complex and much more strategic).
Both in actions and words, FDA noted a renewed commitment to trying to make DSHEA work, despite some late year comments a bit to the contrary. FTC stepped up its enforcement activities (as did FDA) and a continuous theme throughout the year was that "‘Bad Supplement’ Stories Make Good Headlines". Despite positive science to the contrary, November's Vitamin E bashing exercise did widespread damage, hurting sales and perhaps, even more importantly, broad industry credibility. This damage was mitigated a bit by messaging from industry groups and trade associations, who very aggressively created resources and campaigns to counter the presentation of the 'study' results.
Actually, looking back over the course of the year, one sees continued evolution in dialogue between industry associations (even cross border), a much more proactive approach by associations and even more visibly, industry organizations such as DSEA (Dietary Supplements Education Alliance) and ABC (American Botanical Council). The former determined that billions in dollars of health system savings could be implemented through the use of two supplements - calcium + vitamin D and folic acid, and the latter was extremely vocal and proactive in both presenting and defending herbal safety and science.
Other developments of note over the course of the year include qualified health claims for omega-3's, and the continued development of this category, which despite not being allowed as a permitted health claim in Canada, has triggered cross-border activity and interest. CoQ10 is another product that gained increased attention in 2004, and the role of supplements in high levels of sport became an issue, including the use of steroids (and ultimate ban), alleged doping infractions at the World Class Athlete level (some of which were supposedly attributed to supplements and supplement contamination), and the relative ‘escape’ by the supplements industry world-wide throughout the summer Olympics.
Will 2004 eventually be known as the year that exposed serious cracks in the armor of pharmaceutical giants? With the recall of Vioxx by Merck, natural alternatives and their relative benfit/risk ratios began to look more compelling, and I would expect this drop in both consumer and practitioner confidence in the FDA's drug approval process to have some impact on supplement alternatives, particularly those that can establish a decent science base and establish a mechanism of action.
Quality or lack thereof continues to be an industry and consumer concern. Recent consumerlab.com analyses suggest that industry quality is improving, yet product seizures and enforcement actions (such as recent efforts targeting ginseng) would seem to indicate that even while most manufacturers claim they are GMP compliant, there are still huge gaps - and this even for mainstream companies. And, yes, on the subject of GMP's, as 2004 draws to a close - we're still waiting.
With quality such a potentially lethal issue, we are seeing relationship pressures emerging as expectations of suppliers continue to rise. Whether it is certification, product development, or formulation expertise, industry suppliers are being asked to do more for their finished product customers, for supplements applications, as well as for functional foods and beverages.
While other business publications have and no doubt will publish the key business events and issues of 2004, there are a few I'd like to note as well.
The EAS acquisition by Abbott Labs Ross Products Division positioned that organization as a major player in the nutritional products industry globally. Other acquisitions, while less noteworthy and significant (at least in dollar terms) illustrate that the capital market is still available to this sector and that there seems to be reason for optimism and future growth projections. Of note are the activities of Bio-One, Sunopta and Planet Organic over the last twelve months.
Well, obviously GMP's and further detailing of the issues and processes relating to New Dietary Ingredient submissions in the US, implementation and enforcement of regulations in Canada, education in both countries - of media, consumers and industry, continued (hopefully) expansion of funding opportunities for collaborative and sponsored research; and an even higher level of health condition targeted messages including further economic impact evaluations related to specific products. Cardio-protective and metabolic related messages should prove more effective as consumer awareness and sense of responsibility grows, and this could lead to continued growth opportunities for ingredients such as omega-3 products, CoQ10, chromium picolinate and others.
I'd personally like to see further investment in research and unique collaborations that allow companies to leverage the cost of doing this science creatively.
Industry dialogue with legislators and regulators remains critical; this puts a burden on industry leaders. In Canada CHFA and relatively new President Valerie Bell have a key role to play, and in the US, although all major trade associations have been quite active, it will be interesting to see the impact of a new CRN (Council for Responsible Nutrition) President on CRN's activities on Capitol Hill and with the regulators.
2004 could have been a lot worse for the industry, compared to some of the less optimistic predictions.
Is the industry out of the fire and controversy with its existing product mix protected? Not by a long shot. The recent attacks serve only to point out how fragile the marketplace and business environment really is.
In the spirit of the holiday season, (and with a burst of creative energy), and totally for fun, we've created the following 'jingle' for your amusement... Blend together, shake three times, and take two times a day.