In response to growing consumer interest and confusion about natural personal care products, Whole Foods Market (Austin, TX), the world's leading natural and organic foods supermarket, has developed a new Premium Body Care standard and labeling seal of approval, setting a new industry benchmark. The new standard raises the bar for defining quality natural personal care and helps consumers decipher which body care products in its Whole Body™ departments contain the most natural and highest-quality ingredients, according to the company.

"Personal care products are not regulated like food in this country, so there are currently no consistent standards for them laid forth by any governing body. Customers have been bombarded with brands and products claiming to be 'natural,' which can be confusing," said Jeremiah McElwee, senior global Whole Body coordinator. "Our goal is to provide an alternative approach for our customers, so they know that when they see the Premium Body Care seal they are getting safer, higher-quality personal care products. We invite shoppers to look for the new seal, which can be found on nearly 1,200 products in our Whole Body departments."

With nearly 28 years of experience in selling natural and organic products, Whole Foods Market's quality standards for personal care already differentiate the natural and organic retailer in the marketplace—each product found in its Whole Body departments is carefully evaluated and never tested on animals. The company's new seal of approval will identify products that meet the Premium Body Care standard, which do not contain ingredients such as parabens, polypropylene and polyethylene glycols, sodium lauryl and laureth sulfates.

A variety of products found in Whole Body at Whole Foods Market already meet the Premium Body Care standard and will now include the new seal on its packaging. "When considering new body care products moving forward, we will focus on select products that meet the company's new Premium Body Care standard," added McElwee.

"We meticulously examined every personal care ingredient, using the most current research and resources to evaluate products in key areas of safety, naturalness, efficacy, environmental impact and labeling,” said Jody Villecco, quality standards coordinator for Whole Foods Market. “Our research revealed that healthier and safer alternatives to many of the conventional body care ingredients are a viable option."

In developing the Premium Body Care standard, Whole Foods Market worked with chemists and body care experts for more than two years, reviewing body care ingredients and labeling information. As a result, all products bearing the Premium Body Care seal are made with ingredients necessary for them to function well. And, importantly, they contain ingredients that are minimally processed so they have as little impact as possible on the environment during manufacturing and when the products are used.

Key highlights of the new Premium Body Care standard include:
• Preservatives—While few are truly benign, some are necessary in body care products, especially water-based products. The Premium Body Care standard allows only milder preservatives that are shown to function properly—such as potassium sorbate and sodium benzoate—yet have a lower likelihood of causing cosmetic-related allergies and
sensitivities. Parabens and formaldehyde-releasing preservatives (i.e., diazolidinyl urea, DMDM hydantoin) are unacceptable.

• Surfactants—Used for cleaning, degreasing, emulsifying, conditioning and creating foam, these ingredients often irritate the skin and can remove essential fatty acids. The Premium Body Care standard allows only the most gentle types available, including decyl polyglucose and sodium stearoyl lactylate.

• Fragrance—Only natural essential oils and components of natural essential oils are allowed as fragrances.

• Sunscreen—Only physical sunscreen, such as zinc oxide or titanium dioxide, as better alternatives to those containing chemical sunscreens, such as oxybenzone and octyl methoxycinnamate.

The Premium Body Care standard was created to be effective, fair and attainable with the goal of encouraging the body care industry to formulate more products with higher standards.

"We strongly support the efforts of Whole Foods Market to create and continuously improve its Whole Body Premium standard. This important new tool will help consumers choose safer, more environmentally friendly body care products," said Stacy Malkan, spokesperson for the Campaign for Safe Cosmetics and author of the book Not Just a Pretty Face: The Ugly Side of the Beauty Industry.

The marketers of the 7 Day Miracle Cleanse Program, a purported herbal colon-cleansing program, have agreed to settle Federal Trade Commission (FTC) charges that they falsely claimed their program would cure cancer and other serious diseases. Among other things, the settlements broadly ban them from involvement in future infomercials for any product, service or program, except for infomercials for informational publications and from advertising health-related products in the future in any medium.

According to the FTC’s complaint, one of the defendants, Paris DeAguero, appeared as the “Health Man” in nationally televised infomercials, claiming that his program cured him within weeks of skin and breast cancer without the need for surgery or other treatments. Advertising for the program allegedly claimed that it also effectively prevented, treated and cured many other diseases, including AIDS, Alzheimer’s disease, diabetes, high blood pressure and arthritis, and that it safely caused rapid and substantial weight loss. The defendants allegedly also claimed that their product, Parasine 2, was “clinically proven” to eliminate parasites and worms, including tapeworms. The FTC alleged that their claims were false or unsupported by reliable scientific studies, in violation of the FTC Act.

Under two stipulated final orders, 7 Day Marketing, Inc., DeAguero, Dieter Ammann and Laura DeAguero are banned from any involvement in infomercials for any product, program or service, and, regardless of the advertising medium, from representing that any product, program or service can cure, treat or prevent any disease or provide health benefits. The orders exempt representations made in books, newsletters or other informational publications. In addition, the defendants are barred from misrepresenting any test or study concerning any product, program or service. They are also prohibited from transferring, selling or renting personal information collected from customers who purchased the program or its individual products, and they must destroy this information upon the conclusion of certain pending lawsuits.

One of the orders contains a monetary judgment of $14,455,123, which is suspended based on the defendants’ inability to pay. A separate settlement with Dieter Ammann also includes a monetary judgment of $14,455,123, which is suspended upon payment of $70,000, and also is based on his inability to pay. Under both orders, the full judgment will be imposed if the defendants are found to have misrepresented their financial condition.

This case came to the attention of the FTC as a referral from the Better Business Bureau’s Electronic Retailing Self-Regulation Program (ERSP) after the defendants failed to respond to ERSP’s inquiry regarding their infomercial.

Copies of the documents are available from the FTC’s website at http://www.ftc.gov and from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Ave., N.W., Washington, DC 20580.

On February 27, 2008, the US Food and Drug Administration (FDA) addressed a letter to Michael McGuffin, president of the American Herbal Products Association (AHPA), clarifying that the compliance date for the final rule on dietary supplement cGMP (current good manufacturing practice) “will be determined by the number of employees [a company] directly employs.”
 
The cGMP rule was published on June 25, 2007, and comes into effect over the next three years. The specific compliance date for each dietary supplement company depends only on its number of full-time equivalent employees (FTEEs). But the FDA has made statements in various public forums that have suggested that each affected business would need to determine its number of employees—and thus its compliance date—by counting not only its own employees, but also those of all other companies that manufacture its products on a contractual basis. For example, in response to questions on this subject at an FDA webinar on October 24, 2007, the FDA replied that a company’s own employees and those of its contract manufacturers “would all be additive.”
 
“In AHPA’s view, this interpretation was simply wrong,” noted McGuffin. “There is no precedent for such an approach, and it would have resulted in many more small manufacturers being forced into accelerated compliance with the rule.”
 
The FDA’s February 27 letter was in response to a letter from AHPA that posed several questions and scenarios to seek clarification on the issue. The FDA’s response acknowledged that it’s statements at the earlier webinar “seem to be contrary to the intent of the regulation,” and noted its revised conclusion that “the general rule is that a firm that hires an independent contractor to perform any of its manufacturing functions does not add the number of the contractor’s employees to its total for compliance purposes.”
 
“AHPA appreciates the FDA’s willingness to set the record straight on this important detail,” said McGuffin.
 
Based on FDA’s clarification of this point, compliance dates for the final cGMP rule on dietary supplements will be:
• Companies directly employing 500 or more FTEEs: June 25, 2008
• Companies directly employing fewer than 500, but 20 or more FTEEs: June 25, 2009
• Companies directly employing fewer than 20 FTEEs: June 25, 2010

FDA’s letter can be found at www.ahpa.org.

AHPA has submitted comments to the FDA requesting the agency withdraw guidance it issued on the labeling of dietary supplements with respect to the reporting of adverse events.

FDA published two draft guidance documents on January 2, 2008 that were described as “intended to assist … industry” in complying with purported labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

AHPA asserts the draft documents are both unnecessary and contrary to the clear language of the statute. AHPA’s comments express particular concern with the agency’s recommendation that labels bear a “clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of this product.” This recommendation blatantly goes against the stated intent of Congress.

“Under this good law, the FDA had no statutory requirement to issue this guidance,” said Michael McGuffin, AHPA president. “Moreover, the Congress explicitly declared that no additional statements would be necessary on labels other than the address or phone number.”

In his comments on the draft guidance, Andrew Shao, PhD vice president of scientific and regulatory affairs with Council for Responsible Nutrition (CRN) wrote, “We believe the draft guidance issued by the FDA on January 2, 2008 pertaining to the AER Act violates due process for Agency decision making and is unnecessary, and potentially misleading for consumers. CRN requests that the agency make a timely decision and withdraw the guidance, or at a minimum, undergo the normal notice and comment rulemaking process for these interpretations of the Act.”

AHPA’s comments can be seen on the association’s website, www.ahpa.org

Natural Marketing Institute (NMI, Harleysville, PA), a market research and strategic consulting firm specializing in health, wellness and sustainability, reported that its recent Health & Wellness Trends Database™ survey revealed that consumer integration of organic into their lifestyles is growing. New data reveals that total organic household penetration across six product categories is up from 57 percent in 2006, to 59 percent, but some categories are experiencing significant penetration growth while others are flat.

More importantly the number of core users, “Devoteds,” has grown from 16 percent in 2006 to 18 percent in 2007. The percentage of general population/primary grocery shoppers who fall into each of NMI’s organic consumer segments for 2007 and 2006 are as follows: “Temperates” remain steady at 22 percent, “Dabblers” dropped from 44 percent in 2006 to 41 percent in 2007, and “Reluctants” rose from 18 percent to 19 percent.

Devoteds, as their name implies, are the most committed to organic and its ideals and are most likely to have changed their lifestyle to integrate organic. The more a category is used, the more it has to be organic. Temperates have modern organic attitudes and fit organic into their lifestyle; the more they use a category, the more an organic version becomes a treat. Dabblers are non-committal about organic—they can take it or leave it. For them, buying organic is more about hipness than the health benefits. Reluctants are the least trustful of organic and believe that conventional products are just as good (if not better) than organics and that organics are not worth the extra cost.

According to NMI President Maryellen Molyneaux, “NMI research shows that the number of Devoteds is up, and Dabblers are down, which indicates that consumers are moving up the ladder of organic lifestyles. They are learning more about organics, which is leading to increased usage. This reflects the mainstreaming of the organic marketplace and the opportunity that brands have to attract the most loyal segment of organic users—Devoteds.”

More information on NMI’s organic research will be presented at a workshop entitled “Reaching Your Best Organic Target,” which will take place prior to the All Things Organic Trade show on April 25, 2008. More information can be found on NMI’s website at: http://www.nmisolutions.com/r_organic.html.

The Organic Center (Boulder, CO) released a report that concludes converting the nation’s eight million acres of produce farms to organic would reduce pesticide dietary risks by about 97 percent.

The Organic Center provided the first-ever quantitative estimate of the degree to which pesticide risks from food can be eliminated through adoption of organic farming methods in “Simplifying the Pesticide Risk Equation: The Organic Option,” a new State of Science Review by Dr. Charles Benbrook, the Organic Center’s chief scientist.

Less than three percent of the nation’s cropland produces fruits and vegetables. Yet, according to The Organic Center, these crops account for most of the pesticide risks from dietary exposure in domestically produced foods. The 97 percent risk reduction can only be achieved if converting domestic cropland of organic is coupled with consumers choosing only imported produce that is certified organic. The estimates are based on up-to-date pesticide residue data from the US Department of Agriculture, and the Environmental Protection Agency’s current methods for estimating pesticide dietary risks.

Founded in 2002, The Organic Center is a non-profit devoted to presenting and providing peer-reviewed scientific evidence on how organic products benefit human health and environmental quality. Other findings and information shared in the report include:
An analysis of the significantly greater pesticide risks linked to consumption of imported conventionally grown fruits and vegetables, as compared to domestically grown produce;
rankings of dietary risk levels in select conventionally grown fruits and vegetables, arranged to help guide consumers seeking to minimize pesticide risks; and suggestions on how to meet dietary guidelines for fruit and vegetable intake in the winter, while also reducing pesticide exposures.

The Organic Center is offering a free download of its report at www.organic-center.org.

For information, call (303) 499-1840.