Regulatory

At the World Health Organization’s (WHO; Geneva) upcoming European Ministerial Conference on Counteracting Obesity, which will be held in November in Istanbul, Turkey, many of the world’s leading health experts will convene to develop new plans for dealing with the obesity epidemic. With any luck, functional foods will be one of the strategies that helps makes a difference.

Since the passage of DSHEA in 1994, the industry has waited patiently for the advent of official good manufacturing practices (GMPs) for dietary supplements. The arrival of the GMPs, like the much-anticipated emergence of the groundhog, could herald either a long “winter” clouded with new regulatory burdens, or an early “summer” that levels the corporate playing field.

Is the media accurately reporting the results of the latest dietary supplement research? If not, what should the industry do? If so, what can the industry do? Manufacturers have been grappling with these questions for the past several years and may be closer to finding some answers.

Congress recognized that food allergies are a significant problem, and it determined that allergic consumers or caregivers have to make appropriate food selections based on accurate labeling of food products.

Jonathan Emord knows a thing or two about the Food and Drug Administration (FDA; Rockville, MD). He has defeated the agency in federal court a record six times and served as plaintiff’s lead counsel in the 1999 Pearson v. Shalala, 2001 Pearson v. Shalala, 2001 Pearson v. Thompson, and 2002 Whitaker v. Thompson cases.

Until recently, the federal government had said very little about what constitutes a whole-grain food. That changed on February 17, when the Food and Drug Administration (FDA; Rockville, MD) issued a draft guidance document clarifying its views.

Soy makes a great deal of sense. It’s cost-effective, environmentally sustainable, highly versatile, and good for you. No wonder food ingredient manufacturers work long hours formulating new and novel soy-based food ingredients.

In many respects, 2005 is beginning to look a lot like 2004. The Food and Drug Administration (FDA; Rockville, MD) is still promising the “imminent” publication of good manufacturing practices (GMPs) for dietary supplements.

This summer, two events could have a big impact on the dietary supplement industry at home and abroad. The first is that the Codex Alimentarius Commission (Rome) is likely to approve new guidelines for vitamin and mineral food supplements. The second is that the European Court of Justice (Luxembourg) is expected to rule on the validity of the European Union’s (EU) Food Supplements Directive.

Despite what the Washington Post says, the majority of supplement manufacturers take pride in their quality. But even the best quality control (QC) departments are about to be tested.

With the growing focus on good manufacturing practices (GMPs) in the nutritional supplement industry, the sourcing of quality ingredients has become more important than ever before.

New products are the lifeblood of most industries, and dietary supplements are no exception. Innovative new products often contain new ingredients, and as such, it’s essential to develop a workable system for introducing products that contain what are known as new dietary ingredients (NDIs). Currently, FDA (Rockville, MD) is focusing on a provision in the Dietary Supplement Health and Education Act (DSHEA) that outlines an NDI evaluation process. FDA posed several questions in the October 20, 2004, Federal Register and has asked industry and others to comment.

We all know the importance of raw materials to a high-quality product. Raw materials are in fact the foundation of a qualified final product.

With the expected release of the Food and Drug Administration’s (FDA; Rockville, MD) good manufacturing practices (GMPs) for dietary supplements just months away, some companies are still struggling with the new regulations.

Soy foods have come a long way since the early days of tofu and meat substitutes. In the past few years, food technologists have become adept at devising new applications for soy and have expanded the array of choices available to consumers.

It is hard to imagine a better market for low-carb products than California. But sellers of low-carb products in California, if they are not careful, could run afoul of the state’s strict consumer protection laws.

Vitamin and mineral supplement manufacturers are adding more ingredients to multivitamin formulas than ever before.

The herbal product category has had a difficult year. First came the ephedra ban. Then came new studies questioning the efficacy of several common extracts. And in case you missed those items, there was also the article on 'dangerous supplements still at large' in the May issue of Consumer Reports.Despite the steady stream of bad news, manufacturers are optimistic that the category will survive, and even prosper, in the years ahead.