USP Launches Dietary Supplement Program

ROCKVILLE, Md.--The U.S. Pharmacopoeia (USP) officially launched its Dietary Supplement Verification Program (DSVP) in mid-November. The program will allow manufacturers that meet USP standards to carry a certification mark on products that have been tested by USP and shown to contain the labeled amounts of an ingredient, meet acceptable limits of undesirable elements and are manufactured appropriately. According to a USP spokesperson, the USP logo will not be launched until the end of 2002 during a press conference.

USP (www.usp.org) plans to work with manufacturers on the program, which includes lab evaluation of product samples, evaluating manufacturing quality systems through an audit and quality control and manufacturing data reviews. The program does not address structure/function claims nor health or other claims provided for under the Dietary Supplement Health and Education Act (DSHEA). The USP Council of Experts' (CoE) Dietary Supplement Information Expert Committee will initially review all products submitted for verification where safety concerns have been raised.

Mark Cavaliere has been appointed director of good manufacturing practices (GMP) for the DSVP. Cavaliere is responsible for establishing manufacturing, quality assurance and quality control processes and documentation requirements for the DSVP program. In addition, he will assist the vice president of the DSVP program in the evaluation of GMPs, quality assurance and manufacturing records received from manufacturers and contract auditors on facilities and dietary supplement products undergoing the DSVP verification process.

Manufacturers interested in participating in the DSVP program should contact Forouz Ertl, vice president of DSVP, at (301) 816-8316, e-mail fe@usp.org.

2001 Report Lists Best and Worst Impacts on Small Businesses

WASHINGTON--According to a recent compilation of the developments that had the best and worst impacts on small businesses in 2001, the Bush tax cut package was considered the best while the events of Sept. 11 were, unsurprisingly, reported as the worst. Compiled by the Small Business Survival Committee (SBSC) (www.sbsc.org), a 70,000-member nonprofit advocacy group based here, the events that best benefited small business owners were led by the Bush tax cut because it eased the tax burden of the majority of business owners who pay personal rather than corporate income taxes. Additional impacts that were beneficial for small businesses included Alan Greenspan cutting interest rates from 6.5 percent to 1.75 percent in 2001 and Congress approving a two-year moratorium on taxing the Internet.

Topping the list of events having the worst impact on small businesses included the attacks, anthrax scares and deepening recession that Sept. 11 brought to America and its economic partners; the California blackouts which, according to SBSC, lessened business confidence in deregulation; and the change from a Republican-led Senate to a deadlocked Senate, which may stall economic stimulus packages.

Market Research Update

• According to new research by the Natural Marketing Institute (NMI) (www.nmisolutions.com), Americans have increased their focus on health and wellness since Sept. 11. Based on an NMI survey of nearly 2,000 Americans conducted during the week of Nov. 12, resondents plan to increase their purchases of health and wellness products, including dietary supplements, yoga and exercise videos. In addition, 20 percent of those surveyed stated that these lifestyle products and services have helped them deal with stress and anxiety. Thirty percent have also increased concerns about the safety of the food supply since Sept. 11; and 8 percent reported they plan to increase purchasing of organic and natural foods as a result.

• Research from SPINS (www.spins.com) reported that nationwide sales of health and wellness products in conventional retail outlets grew 21.5 percent vs. the same period a year ago. "[This upturn] clearly shows that for many Americans, these products are increasingly a necessity, not a luxury," said Paddy Spence, chief executive officer. "In uncertain times, one way shoppers can take control of their own health and well-being is through the products they consume, and natural and organic products, as well as dietary supplements, fulfill that need."

• According to a new report from The Hartman Group (www.hartman-group.com), the marketing of vitamins, minerals and other natural care products continues to be dominated by drugstores. Almost half (48 percent) of vitamins and minerals are bought at the drugstore level, followed by grocery stores (19 percent), mass discounters (18 percent), vitamin stores (6 percent), direct mail companies/manufacturers (7 percent) and other channels (2 percent). In the world of herbal supplements, drugstores have a more narrow margin, selling 33 percent of the nation's herb products, followed by mass discounters (16 percent), direct mail companies/manufacturers (15 percent), vitamin stores (13 percent), grocery stores (10 percent), natural food stores (7 percent) and other outlets (6 percent).

Scan Genius, Living Naturally Offer Ordering Software

SARASOTA, Fla.--Scan Genius Inc. and Living Naturally have teamed up to market Scan Genius ordering software for the natural products industry. This system is integrated with Living Naturally's existing Customer Relationship Management software and is equipped with a hand-held scanner utilizing Palm OS and Scan Genius software that can access 60,000 products. The system can transmit orders to manufacturers and distributors and may cut down the work of product ordering by 50 percent, according to the companies. Retailers are charged a low monthly subscription fee per unit. For more information, e-mail info@livingnaturally.com

Intramedicine Appoints Zeisel to Advisory Board

WESTLAKE VILLAGE, Calif.--Intramedicine Inc. appointed Steven Zeisel, M.D., Ph.D., to its medical advisory board. Zeisel is currently the chairman of the Department of Nutrition at the University of North Carolina, Chapel Hill. He is a president-elect of the American Society for Nutrition Sciences (ASNS), a member of the scientific advisory panel for dietary supplements at the Food and Drug Administration (FDA) and is the founding editor of the Journal of Nutritional Biochemistry.

NCPA: Independent Pharmacies Increase Sales for 2000

PHILADELPHIA--Late last year, the National Community Pharmacists Association (NCPA) released its 2001 NCPA-Pharmacia Digest, which reported that independent community pharmacies posted record sales in 2000. According to the Digest, independent pharmacies experienced a 16.7-percent sales increase over the year prior for an average of $2.3 million per pharmacy.

According to NCPA (www.ncpanet.org), independent pharmacies--including single-store independent pharmacies, independent chains, independent franchises and independent pharmacist-owned supermarket pharmacies--now number 24,841, with the addition of more than 200 new pharmacies in 2000. Independent pharmacies now make up the largest segment of the retail pharmacy marketplace and are 45 percent of the nation's 55,011 pharmacies.

The Digest also reported that the top sales in the over-the-counter (OTC) category for the independent pharmacist were vitamins and dietary supplements, smoking cessation aids and first aid products.

Man Behind Aloe Vera "Cure-All" Imprisoned and Fined

WASHINGTON--Last year, a federal jury reached a deadlock over 19 counts of conspiracy, selling an unauthorized drug and committing wire fraud in a trial accusing a businessman of selling AIDS and cancer patients an expensive aloe vera solution marketed as a cure. That case has come to a conclusion: Allen J. Hoffman, the man behind the "remedy," has been sentenced to 46 months in prison and $222,506 in fines.

According to a Dec. 5 Talk Paper issued by the Food and Drug Administration (FDA), Hoffman pled guilty to two felony counts of introduction of an unapproved new drug into interstate commerce with the intent to defraud the public. Under the Federal Food, Drug and Cosmetic Act, it is illegal to market a drug that has not been approved by the FDA to treat specific conditions.

This intravenous aloe vera treatment was administered by some physicians who sold it for upwards of $18,000 during a two-week period; in the United States, it is illegal to sell aloe vera for intravenous use. When he was tried last year, Hoffman claimed he did not intend the intravenous treatment to be used by U.S. citizens.

According to FDA, more than 3,000 people purchased products from Hoffman, who also falsely claimed to have a doctoral degree. Hoffman's companies that sold this product--T-Up Inc. in Baltimore, Md., and Hanover, Pa.-based Astec Biologics Inc.--are both out of business, according to a person at Astec. The companies had no comment on this matter.

Marc Ullman, an attorney in the natural products industry, said that although he does not know all of the details in the case, this court decision serves as a reminder to those who may follow in Hoffman's footsteps. "Anyone who sells any dietary supplement or purported dietary supplement as a cure for cancer or AIDS risks prosecution, such as in this instance," he commented. "FDA was squarely within the letter of the law [when it went after this company]. Anyone who is thinking about selling a product like this risks similar treatment."

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