Regulatory

  If one word could summarize the industry’s hopes and fears over the past 12 months, that word would be safety. A string of food scares in 2007 severely eroded public confidence in FDA. Meanwhile, a wave of negative media articles dented public confidence in dietary supplements and functional foods, two market segments that have been under increasing scrutiny.

  Food is critical for human existence. However, food goes beyond nourishment, as it encompasses a multitude of human experiences and emotions, and these vary between cultures and religions. More recently, food is being used and appreciated differently by women and men.

  When members of Congress hold a hearing, it’s usually not a sign of good news. However, when the House Subcommittee on Horticulture and Organic Agriculture convened on April 18 to discuss the status of USDA’s National Organic Program (NOP), it heard some very good news: organic products accounted for nearly 3% of all retail sales in 2005, pulling in just under $15 billion for the year.

  Government officials, consumer advocates, and industry representatives debated how FDA should regulate functional foods at a public hearing held December 5.

 Weight-loss supplements have taken a drubbing in recent years from government officials, consumer groups, and the media. A key issue behind the controversy is the level of scientific substantiation for product claims. While researchers haven’t reached a consensus about the effectiveness and safety of most weight-loss products, many popular natural ingredients do have some supportive data, and the number of research studies generating useful information is growing.

Why is there a growing trend in the U.S. vitamin industry to purchase raw materials in China?

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.