By Len Monheit
In what many anticipated would be a light news week, the opposite occurred as first the New England Journal of Medicine published a series of articles dealing with herbals and botanicals including questioning products and regulations, and then the FDA and FTC held a Joint News Conference where they announced plans to allow science-based health claims for conventional foods, at the same time announcing that they will be launching a new initiative to crack down on false and misleading advertising for dietary supplements.
The NEJM articles begin with a review on "Herbal Remedies" by Dr. Peter De Smet of the Netherlands which deals in a relatively balanced manner with regulation, quality, safety, and efficacy. A second journal article, quite critical of safety, benefit and quality of herbal medicines is provided by Dr. Stephen Straus of the National Center for Complementary and Alternative Medicine and a final piece, calling for new regulations and examining existing regulations is provided by Dr. Donald Marcus of Baylor and Dr. Arthur Grollman of SUNY.
CRN (Council for Responsible Nutrition), link to release, and ABC (American Botanical Council) link to release, both hit the wires proactively anticipating media pickup of the articles, which interestingly enough, has not materialized. The releases admit to challenges, and outline some of the historical use and evidence, as well as difficulties encountered in herbal analysis.
The FDA/FTC announcements received more media attention, and will have broader implications for the industry as a whole. The objective stated was to allow consumers to make better and more informed decisions and to gain more information about health and nutrition, an excellent objective and one which should benefit consumers and much of our industry. Previously under Pearson vs. Shalala, dietary supplement companies defended their ability to make substantiated health claims, but this right was never passed along to food products. In fact, the entire category of âfunctional foodsâ has never been defined and recognized as a category.
The FDA release indicates the Consumer Health Information for Better Nutrition initiative is designed to encourage makers of conventional foods and dietary supplements to make accurate, science based claims about health benefits, and to help eliminate bogus labeling claims by taking on those supplement marketers making false and misleading claims.
According to Marc Ullman of Ullman, Shapiro Ullman, LLC, "At first blush it appears reasonable. Critical issues will include whether any enforcement activities will be even-handed or will the supplement industry bear the brunt of FDAâs action while the âmainstreamâ food industry is allowed to do as it pleases?"
Ullman further questions FDAâs commitment to the Education part of DSHEA, despite statements that they believe consumer education is part of their mission. He notes as an example the Lane case where FDA took the position that, â âthird party literatureâ is âevidence of intended useâ. If that is the case, any company that distributes a study out of JAMA discussing Astaxanthin as beneficial in the treatment of macular degeneration, or any other eye disease, is at risk because use of that article is evidence of the companyâs intent to market their product as a disease treatment. (FDA has also argued that mailings to health care professionals cannot be third party literature). This week's FDA position would eviscerate the third party literature provisions of the law.â
It seems possible that the supplements industry will face further challenge from the impacts of the FDA position and statement. Yet, underneath, is an admission and opportunity.
A key issue which has challenged the industry for some time is the awareness level of consumers regarding health and nutrition issues. The implementation of this program may seriously address that issue as it raises the baseline levels of education. If, at the same time, it is realized that the mainstream diet is nutritionally deficient, (as has been suggested by MDâs, and diet and nutrition experts around the world), then the logical course is that supplementation or fortification is required in order to enhance consumer nutrient intake.
This ultimately will likely lead to one of two scenarios, a thriving and burgeoning supplementation market, as a more aware consumer base actively seeks products providing nutritional value, or an active functional food category offering a range of products with different and openly stated nutritional content and benefits.
These and other issues such as the FTC crackdown on supplement marketers should be an alert to these unscrupulous marketers that time is running short, whether enforcement follows this past weekâs announcement or not. The Grocery Manufacturers of America and the National Food Products Association have both quickly embraced link to releases? the announcement and guidance document, and one would think that many food manufacturers will as well.
Ingredient manufacturers who have anticipated the development by seeking GRAS affirmation and entering the ânutritionâ space have an early advantage, and I would think ingredient manufacturers with a strong proprietary science base will come out extremely well in the long run in the âfunctional categoryâ growth.
Itâll take some time before comments are in, enforcement begins, and the opportunities mature. Leading companies are already in motion.
On the lighter side (sing to 'Santa Claus is Coming to Town' theme)
You better watch out, you better not lie
If youâre in doubt, your sales will be dry;
FDA is coming to town.
Theyâre making a list, checking it twice
Trying to find whoâs getting poor advice
FDA is coming to town.
Theyâll track your product safety,
Theyâll nail unsupported claims,
FTC will back them up,
Our industry it shames, soâ¦
You better watch out, you better not lie,
Quality in, consumers will buy,
Or the FDA is coming to town.
(Inspiration provided by DS)
Comment on this week's Editorial: You Better Watch Out!