By Len Monheit |
As we leave 2003 behind us, it’s a good time to reflect back on the past twelve months and the highlights (and lowlights). This also provides us an opportunity to come out fighting in 2004 since many of the battles fought in 2003 were mere salvoes in a much broader conflict that will face us head on in the New Year.
What follows is not a complete recap or analysis of the year, its just some of the significant or defining moments the industry experienced in the past twelve months. Let’s roll back the clock…
Several highly credible and high profile studies were published, in addition to reviews and meta-analysis that were less favorable about specific products or entire categories.
Media negativity and criticism reached new highs, triggered by strong associations between dietary supplements, weight loss products – and ephedra.
‘Low carb’ and ‘trans fat free’ became the approaches of choice in product introductions.
Legislative pressure was felt in North America and in Australia and New Zealand. Canada finalized its new regulations for natural health products set to launch in January 2004, while debate raged on Capitol Hill will several pieces of legislation tabled which would dramatically affect the industry including Senator Durbin’s S. 722. and the Bill to fund FDA (S. 1538) to implement DSHEA. FDA finally presented its proposed GMP’s and received significant response from industry trade associations and companies at most levels of the industry value chain.
Industry trade associations were active and in some cases proactive in their attempts to present a responsible maturing industry. There was also increased evidence of the industry trade associations working together.
Several successful executive level conferences and summits were held over the year, suggesting that top level networking and peer discussions are important for industry decision makers.
Month by Month
- FTC steps up its weight loss products enforcement efforts.
FTC Obtains Stipulated Preliminary Injunctions with Asset Freezes Against Officers of Mark Nutritionals, Inc.
- FDA establishes a task force on consumer health information for better nutrition and proposes regulations for registering food facilities and prior notice.
FDA Task Force on Consumer Health Information for Better Nutrition Established
- A Lancet article notes that better safety controls are needed for supplements.
Lancet Article Notes That Better Safety Controls Needed for Dietary Supplements in the USA
- NSF and USP both gain momentum in their certification efforts.
- NMI reports that the Health and Wellness sector had reached $56 Billion.
NMI Reports 2002 Health & Wellness Industry At $59 Billion
- Bastyr Naturopaths join the Medicare advisory group.
Bastyr naturopaths join Medicare Advisory Group
- The results of the Rand report on ephedra and other concerns cause HHS to begin several actions including a rapid comment period on the subject.
HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra
- More NSF certifications are announced.
TSI Receives NSF Ingredient Certification and GMP Plant Registration
NSF Certifies Amerifit Nutrition Sootherbs and FlexAble(tm) Brands
- Baltimore Oriole pitcher Steve Bechler dies in training camp, use of ephedra alleged to contribute to his death.
Xenadrine Reaction on Baseball Player's Death
- NBJ states global nutrition industry sales passed $150 Billion in 2001.
Global Nutrition Industry Sales Grow 7.7% in 2001 to reach $150-billion
- Suffolk County in New York bans ephedra.
Gaffney Signs Historic Law Banning Ephedra Products
- FDA issues proposed GMP’s for supplements.
FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements
- NBTY acquires GNC’s UK business.
NBTY Acquires GNC Business in United Kingdom
- Industry calls for science based ephedra regulations.
Industry Supports HHS and FDA Call For Science-Based Regulations
Baltimore Pitcher Steve Bechler’s Toxicology Report Prompts Industry Call For Science-Based Ephedra Regulations
- NBTY ceases ephedra sales.
NBTY Ceases Ephedra Sales
- Numico puts its supplements business up for sale.
Numico announces the sale of part of the European supplements activities
- California begins the process to license ND’s which would eventually pass into law in September.
President of California Senate Introduces Measure to Expand Consumer Access to Naturopathic Medicine
- Pan Pharmaceuticals (Australia) manufacturing license revoked due to rampant quality problems, thousands of products around the world recalled including many supplements.
National Medicines Regulator Suspends Drug Company's Manufacturing Licence
- FDA releases proposed food safety regulations.
FDA Issues Final Two Proposed Food Safety Regulations
- Industry trade associations unite with a public comment about the inappropriateness of making claims associated with SARS and a few weeks later, do the same with Coral Calcium.
Dietary Supplement Industry Supports FDA and FTC Actions on Sars-Related Claims
Supplement Industry Trade Association Urges Crackdown on Coral Calcium Claims
- NNFA moves to DC, closer to the legislative ‘action’.
NNFA Opens D.C. Office
- GNC discontinues ephedra.
GNC's Statement On the Discontinuation of the Sale of Ephedra-based Products
- Sabinsa aggressively pursues protection of its IP protection – right on the SupplySide East show floor.
Sabinsa Protects IP Position on SupplySide East Trade Show Floor
- Nutraceutical announces the acquisition of Nature’s Life.
Nutraceutical to Acquire Nature's Life
- FDA and FTC step up their campaign to combat deceptive advertising, specifically for weight loss products.
FTC and FDA Take New Actions in Fight Against Deceptive Marketing
- Natural Health Product GMP’s are posted in Canada Gazette II, targeted to begin as law January 2004.
Minister McLellan Announces the Adoption of New Regulations for Natural Health Products
- A Lancet article slams beta-carotene and vitamin A – industry responds.
Lancet Published Meta-Analysis of Antioxidant Vitamins Actively Discourages Beta-Carotene and Vitamin A Supplementation
- According to Natural Foods Merchandiser, Natural Product sales reach $36 Billion in 2002.
Natural Products Sales Top $36 Billion in 2002
- NBTY announces the acquisition of Rexall Sundown.
NBTY to Acquire Rexall Sundown
- Nestle and Colgate announce a JV in functional confectionary.
Nestle and Colgate Enter Joint Venture for 'Functional Confectionary'
- FDA announces its policy on making qualified health claims for foods.
FDA to Encourage Science-based Labeling and Competition for Healthier Dietary Choices
- Battle rages in the UK over the EU Food Supplements Directive.
Battle in UK Over European Food Supplements Directive
- On Capitol Hill, ephedra hearings start, arguably the industry’s 2004 low point.
Capitol Hill Ephedra Hearings Start Wednesday July 23rd
FTC Testifies on the Marketing of Dietary Supplements and Weight-Loss Products Containing Ephedra
- The deal between Roche and DSM is progressing, expected to close in the fall.
DSM, Roche Deal Clearing EU Hurdles
- Abbott Laboratories completes the acquisition of Zone Perfect Nutrition.
Abbott Laboratories Completes Acquisition of ZonePerfect Nutrition
- Consumerlab.com grudgingly admits that quality is improving in ginseng supplements.
Some Problems Persist With Ginseng Supplements But Overall Quality Imporves According to Consumerlab.com
- JAMA publishes two critical articles and a critical editorial on herbs.
JAMA Publishes Articles on St. John's Wort Interactions, Claims for Herbs on the Internet, and an Editorial on Herbs
- DSM / Roche Vitamins deal clears in the US.
DSM, Roche Deal Gains US Approval
- FDA launches its on-line registration for food facilities. Several weeks later, only 10 percent of all facilities had registered.
FDA to Launch On-line Facility Registration October 16th as Part of Bioterrorism Act Regulations
FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes 'Live', Allowing More Than 400,000 Facilities to Register in Minutes
- California bans ephedra.
California Governor Signs Bill to Ban Ephedrine-Containing Supplements
- Less than a week following industry’s Rally Day on Capitol Hill, supplements are center stage at Senate committee meetings.
Senate Committee on Commerce, Science and Transportation Discusses Supplements
- In Australia, reforms are announced intended to restore confidence in supplements following the Pan Pharmaceutical ‘situation’, ignoring the fact that it was not supplements which triggered the crisis in the first place.
Government Moves To Restore Confidence In Complementary Medicines Industry
- Numico announces the sale agreement for GNC to Apollo management L.P.
Numico to Sell GNC to Fully Focus on Core Businesses
- Biden / Hatch legislation is introduced to control anabolic steroids including andro. Industry actively supports the legislation.
Industry Associations Support biden/hatch Legislation
- IdeaSphere completes its acquisition of Twinlab
IdeaSphere to Complete Acquisition of Twinlab
- The state of New York bans ephedra.
N.Y. Bans Ephedra Sales
- Codex announces it will support a science-based rationale for supplements.
Codex Committee Backs Science-Based Safety Standards for Vitamin and Mineral Supplements
- NBJ reports that niche categories drove an overall 4 percent industry growth in 2002.
NBJ Report Finds Niche Categories Drive Supplement Industry Growth 4% in 2002
- Horizon Organics shareholders approve the acquisition by Dean Foods.
Horizon Organic Holding Corporation Stockholders Approve Acquisition by Dean Foods Company
- Bastyr University research is published in the Journal of the American Medical Association (JAMA).
Bastyr University Research Published By Nation’s Most Prestigious Medical Journal
- FDA’s Food Safety legislation becomes law.
FDA and CBP Define Their Transitional Compliance Policy on Food Imports
- A trans-Tasman treaty is signed which includes joint regulation of Health Products between Australia and New Zealand.
Debate Over Trans-Tasman Regulation of Therapeutic Products in New Zealand Continues
- Novartis Announces it will buy Bristol-Myers' Nutrition Business
Novartis to Buy Bristol-Myers' Nutrition Business
The outlook for 2004 is far from clear. Education appears to be a key word circulating among many industry leaders as their critical objective, whether we’re talking about legislators in Washington, use of qualified health claims on food products to educate consumers, in store retailer programs or a shifting burden for category development and education to ingredient suppliers.
As many of the industry guru’s have stated, the days of the blockbuster product driving industry growth are over. Steady, responsible, strategic growth is typically more sustainable anyway.