May 11, 2009 The Pump Handle 2Comment

By Myra Karstadt

Peanuts, pistachios, peppers (maybe tomatoes too), spinach, spices……….The list of produce recalled due to bacterial contamination gets longer, and baleful glances are  cast at the Center for Food Safety and Applied Nutrition (CFSAN- say siff-san), the part of FDA charged with regulating the safety of those agricultural products.

With any luck, sometime during the next few years, the organization within CFSAN that deals with the safety of agricultural produce, the Office of Food Safety, will be moved over to a new food safety agency.  Unfortunately, based on past history, CFSAN will continue to mis-regulate, under-regulate, or just ignore several important groups of products left behind when produce safety moves out.  It’s worth taking a look at what will be left when food safety leaves, and it’s also worth taking long-overdue steps to improve FDA regulation of food additives, cosmetics and dietary supplements.

Food additives
Food additives are cosmetics for foods.  Food additives can provide color, flavor, fragrance, long shelf life, and good “mouth feel.”  Direct additives are deliberately added to foods to impart desired qualities.  There’s also a large group of indirect additives, which aren’t deliberately added to foods, but which get into food when it comes into contact with packaging, such as the grease-resistant wrapper of a fast-food hamburger, or processing equipment such as conveyor belts that have residues of resins or other chemicals used in their manufacture.  

 Since food additives are cosmetics, they are not supposed to change the nutritional quality of a food.  And since food additives shouldn’t affect how nutritious a food is, efficacy of the additive shouldn’t matter.  The only factor that should matter is safety, and that’s where CFSAN has routinely failed. 

CFSAN is supposed to clear food additives – both direct and indirect – for safety before additives can be marketed.  In the mid-1990s, FDA carried out particularly interesting pre-market safety reviews for two food additives – olestra (a synthetic fat probably best known for its association with unfortunate side effects) and acesulfame, an artificial sweetener about which I’ve written in a previous post.  In both cases, CFSAN routinely ignored important scientific data, turned a deaf ear to objections to the additive raised by scientists outside and within the agency, and often demonstrated a bias in favor of industry.

What little news there has been about food additive reviews at FDA in the past few years hasn’t indicated that regulation of food additives has been improving at FDA.  These days, Americans are eating a tremendous volume of processed foods, which tend to be loaded with additives, so improvement in regulation of food additives is definitely in order.

Everyone uses cosmetics. Even people who think they don’t use cosmetics use them. Everyone uses cosmetics because of the way cosmetics are defined in the FFDCA.  Basically, if a product makes drug claims, stating that the product will change the structure or function of an organ system, that product is going to be regulated as a drug. If a product label doesn’t make any claims of “changes in structure or function,” the product is considered a cosmetic, and is subject to a much less stringent regulatory regimen. 

That distinction between drugs and cosmetics has some strange results.  For instance, a deodorant masks odors.  Perfume is a deodorant.  Deodorants don’t claim to change how or where the body releases perspiration, so deodorants are regulated as cosmetics.  Anti-perspirants, on the other hand, change how and where the body releases perspiration and are regulated as drugs.

 A few weeks ago, a group affiliated with the Environmental Working Group came out with a useful and interesting report on hazardous chemicals in cosmetics.  That report focused on two carcinogens –  1,4-dioxane and formaldehyde – found in baby products.  Those two carcinogens can be formed during manufacture of cosmetic products. Cosmetics have long been known to contain a large number (and great variety) of hazardous chemicals, carcinogens and non-carcinogens.

 Cosmetics have harmed Americans in the past.  Bubble baths for babies, deodorant containing vitamin E, and permanent colors for eyelashes are among the cosmetic products that have injured people in the United States.

In large part, problems with cosmetic regulation are due to weak provisions in the Federal Food, Drug and Cosmetic Act (FFDCA), and FDA’s utter failure to enforce even those provisions that are available to provide some assurance of safety for the public.  FDA’s repeated (and sometimes rather creative) efforts to wriggle out from under the regulatory structure provided in the FFDCA should concern members of the public and Congress.  Unfortunately, Congress has actually managed to make matters worse at times, yielding to complaints engendered by fake grass-roots campaigns (most notably a campaign sponsored by marketers of hair colors) to stand in the way of FDA regulating some of the more hazardous cosmetic products. 

Cosmetic regulation has been a CFSAN responsibility for decades. It’s high time for Congress and senior Administration officials to took a look at what CFSAN has (and has not) been doing to regulate cosmetics.  New laws and increased efforts by CFSAN will be needed to ensure cosmetic safety.

Dietary supplements, herbal and “natural” products    
Dietary supplements run the gamut from metals such as selenium, through mega-vitamins (such as 2 gm doses of Vitamin C) to complex herbal products such as echinacea or gingko biloba. Although CFSAN is responsible for regulating dietary supplements, the Center did little about the products until 1994.  In 1994, Congress, at the behest of the supplement industry and some well-orchestrated fake grass-roots campaigns purporting to express people’s concerns that government was going to take away Americans’ rights to buy and use vitamins of their choice, passed DSHEA (the Dietary Supplement Health and Education Act of 1994).  DSHEA’s title makes it sound like a law designed to protect the public, but it is actually a law designed to help marketers of dietary supplements by preventing FDA from regulating those products.

In essence, what DSHEA does is raise the bar FDA has to jump over to get an unsafe dietary supplement off the market.  Since there is no safety pre-clearance for dietary supplements and since marketers have a pretty broad authority to make what are really drug claims for their products, the public is at risk from injury caused by using dietary supplements. 

In the mid-nineties, FDA held hearings on deaths related to the use of ephedra.   Ephedra is a plant-derived herbal supplement (a “natural product” with ephedrine as a constituent) that was being used as a weight-loss aid.  Ephedra helps reduce weight by speeding up metabolism, but that speed-up can harm the circulatory system.  In fact, FDA’s hearings were spurred by reports of deaths caused by heart attacks as well as non-fatal but severe circulatory system problems among healthy young women.  In response to those deaths and illnesses, FDA required some changes in dosage and labeling. 

The labeling changes proved ineffective.  Young dieters, mainly female, continued to use ephedra, and illnesses and deaths continued to occur.  In 2003, a pitcher for the Baltimore Orioles died of ephedra-related cardiac effects.  His death finally prompted FDA to ban ephedra products.(U.S. Food and Drug Administration. FR 69 (28) (February 11, 2004). Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk; Final Rule). 

Recent headlines about hydroxycut, another dietary supplement used as a weight-loss aid, remind us that dietary supplements need some serious regulating.  Newspaper articles on hydroxycut being taken off the market pointed out that the product wasn’t banned by FDA.  In fact, hydroxycut’s marketer did a voluntary recall after deaths and liver disease were identified among hydroxycut users.  The articles also noted that, thanks to DSHEA, FDA is unable to require demonstration of safety before dietary supplements go on the market.

 Controlled studies of efficacy of several dietary supplements have shown that the products are ineffective for protecting health. The difficult economic times may prompt people to use hazardous and/or ineffective dietary supplements rather than go to a doctor for treatment or prevention of illness. 

Given the likelihood that uninformed consumers are not being protected adequately against ineffective and potentially harmful dietary supplements, now is an especially good time to get rid of DSHEA and get some action on regulation of dietary supplements at FDA.

A big poorly regulated trifecta: time to regulate!
It’s likely there will soon be a big push to get food safety out of FDA.  That’s good, but moving an office focused on produce safety out of CFSAN shouldn’t keep consumers, press, and legislators from pressing for better and stronger FDA actions on the range of products for which it’s still responsible. Food additives, cosmetics and dietary supplements need much stronger action by Congress and FDA to protect public health. 

Myra L. Karstadt, Ph.D is a consultant in toxicology, and is located in Chevy Chase, MD.

2 thoughts on “To boldly go where FDA has not gone before: vigorous regulation needed for food additives, cosmetics, and dietary supplements

  1. When starting any supplementation you always need to choose a high quality brand that produces in the US where manufacturing is guided by GMP’s (Good Manufacturing procedures)

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.