Chapter 4

Center for Food Safety and Applied Nutrition continued

Dietary Supplements (Continued)

Dietary Supplements Containing Aristolochic Acid

On June 20, 2001, the FDA warned consumers to discontinue use of thirteen Chinese herbal products containing aristolochic acid because they could present a serious health hazard to consumers. The Nationwide Alert stated that “Aristolochic acid, found in certain plants and botanicals, is toxic to the kidneys and is a potent carcinogen. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. The use of aristolochic acid-containing products has also been linked to increased risk of kidney cancer in people who have consumed it.”

Blue Light, Inc., Ithaca, New York, initiated a recall of products sold under the "Treasure of the East" label with "MFG No. 200008" (2000=year, 08=month) and earlier production dates. Products with "MFG No. 200009" and later production dates were not affected.

These products were distributed nationwide in small quantities primarily to acupuncturists, herbalists, and herbal stores. They were in powder form (3.5 oz. bottles) or capsule form (100 per bottle) under the "Treasure of the East" label. The recall was initiated as a result of public health concerns associated with the consumption of aristolochic acid products.

Blue Light, Inc., discontinued the distribution and use of products that may contain aristolochic acid. Consumers who have purchased any of these products with affected expiration dates should discontinue their use and may return them to place of purchase for a full refund. Consumers with questions may contact the company at 1-888-258-3548.

Pacific Biologic Recalls Seven Herbal Products

On July 31, 2001, the FDA issued a Press Release reporting that Pacific Biologic Co., Clayton, California, was recalling capsules containing the herb Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin). These herbs may present a serious health hazard to consumers because they contain aristolochic acid. The herb Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin) were part of the formula for products listed below and distributed nationwide to medical doctors, naturopathic physicians, licensed acupuncturists, and herbal practitioners. The products were labeled under the following brands and included all lots and production codes:

HERBAL MASTERS ARPANEX B
HERBAL MASTERS CYS
HERBAL MASTERS KOMS A
BALANCE & HARMONY ARTIFLEX B
BALANCE & HARMONY GENTIANA COMBINATION
BALANCE & HARMONY ALLERHAY
PACIFIC BIOLOGIC ORTHOFLEX

These herbs were sold in white plastic bottles containing capsules of herb powder with labels identifying the herb as Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin).

The recall was the result of a notice from the FDA that aristolochic acid was classified as a Class 1 toxic substance. The company ceased the production and distribution of all forms of these herbs. Consumers who purchased or were prescribed these herbs were advised to immediately discontinue their use and return them to the place of purchase for a full refund.

FDA Assists Firm in Class 1 Recall

The FDA’s New England District Office assisted Vital Nutrients of Middletown, Connecticut, in a voluntary recall of Vital Nutrients Joint Ease, Capsules 60 and 120 count and Verified Quality Brand Joint Comfort Complex, Capsules 60 and 120 count, Hypoallergenic Dietary Supplement. Testing of these products by the Independent Laboratory-ADPEN Laboratories, Jacksonville, Florida, on May 9, 2001, confirmed the presence of Aristolochic Acid at 0.38 ug/ml (9.5 ppm). Aristolochic Acid is a potent carcinogen and nephrotoxin (Class I).

Vital Nutrients notified accounts by letter via First Class Mail on May 22, 2001. Accounts were requested to discontinue use and/or dispensing and to return all products to the recalling firm. Vital Nutrients issued a Press Release to AP on May 21, 2001. The firm monitored responses and contacted non-responders after 14 days. All products were destroyed at the conclusion of the recall.

Voluntary Destruction of Herbal Supplement

On May 29, 2001, the FDA’s New England District Office witnessed the voluntary destruction of an herbal supplement containing aristolochic acid. FDA investigators witnessed the voluntary destruction of 1057/90 capsule bottles and 273/30 capsule bottles of "Neo Concept Aller Relief," an herbal supplement found to contain aristolochic acid. The supplement was distributed and recalled by BMK International Inc. Wellesley, Massachusetts. The recall (F-415-1) was initiated by BMK International Inc. on January 19, 2001. The estimated retail value of the product voluntarily destroyed was $34,475.

Dietary Supplements Recalled Because Of Possible Salmonella Contamination

On April 27, 2001, the FDA announced that Solgar Vitamin and Herb Company of Leonia, New Jersey, was recalling 754 bottles of Solgar's Digestive Aid 100's dietary supplements. The firm initiated the recall because the product had the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Bottles of Solgar's Digestive Aid 100's were distributed from March 30, 2001, to April 20, 2001, to retail stores nationwide and in some foreign countries, including the United Kingdom, France and Israel.

The product came in brown bottles with yellow labels that had an orange stripe on the bottom. The bottles being re called were marked with lot numbers 31993 or 30957 that were printed above the expiration date on the bottle neck. The label read in part, "Solgar Digestive Aid - Dietary Supplement - 100 Tablets - Sugar and Starch free."

The recall was the result of a routine sampling program by American Laboratories Inc., of Omaha, Nebraska, which detected Salmonella in the raw material, pepsin, that was used in Solgar's dietary supplement.

Biotics Research Recalls Two Products Due to Possible Salmonella

On August 3, 2001, Biotics Research Corporation of Rosenberg, Texas, initiated a recall of specified lot numbers of Hydrozyme 90 and 250 tablet size bottles and HCL-Plus 90 tablet size bottles because they had the potential to be contaminated with Salmonella. Bottles of Hydrozyme and HCL-Plus were distributed nationwide from February 19th to April 25th, 2001. The product came in white bottles with blue labels. The Hydrozyme lot numbers being recalled were 21173, 21245 and 21280. The HCL-Plus lot number being recalled was 21150. The lot numbers appeared above the expiration date on the label.

The recall was the result of a routine sampling program and request for a recall by American Laboratories, Inc., of Omaha, Nebraska, the supplier who detected Salmonella in the raw material pepsin that was used in the product. While in house and independent laboratory testing did not detect Salmonella in samples of the Biotics Research products, the voluntary recall provided a high measure of safety.

Street Drug Alternatives

Hit Products, Inc., and Organic Diversions, Inc.

United States v. Undetermined quantities of articles of drug, street drug alternatives (D. Md.) On June 12, 2001, a District Court Judge signed an order granting the government's motion for summary judgment in this case involving street drug alternatives manufactured and promoted by Hit Products, Inc., and Organic Diversions, Inc. The order condemned the seized drugs as misbranded and unapproved new drugs, ordered their destruction, and enjoined the defendants from introducing similar misbranded and unapproved new drugs into interstate commerce. The order also prohibits the defendants from promoting such drugs within the court's jurisdiction if such promotion causes the drugs to be misbranded. Moreover, the court order requires the parties to attempt to negotiate a proposed consent decree to address more specific injunctive relief to implement its ruling.

This case was the agency's first suit following issuance of a guidance document in April 2000 informing the public that any product promoted as an alternative to illegal street drugs would be regarded by FDA as a misbranded and unapproved new drug.

The complaint in this case alleged that the defendants' products are drugs because they are intended to be used as substitutes for illegal street drugs, such as marijuana, Ecstasy, hashish, and opium. As such, the products are intended to induce in the user psychological effects similar to those intended by the street drugs they mimic and, because the products are not generally recognized as safe and effective for their intended uses and have not been approved under the new drug approval process, they are in violation of the law.

The court found FDA's position on street drug alternatives "highly persuasive" and the characterization by defendants of the seized products as dietary supplements was a "veiled attempt to circumvent " the Federal Food, Drug, and Cosmetic Act. The court "declined to carve out a statutory loophole for drug manufacturers attempting to profit from the illegal drug epidemic by masquerading potentially dangerous substances as legitimate dietary supplements." Moreover, the court held that FDA's regulation of street drug alternatives in accordance with the agency's policy delineated in its guidance document is not an attempt to regulate advertising. In recognizing that the agency used the defendants' promotional materials as evidence of the products' intended uses, the court held that such use of promotional materials does not implicate the First Amendment.

Hit Products, Inc., and Organic Diversions, Inc. Enjoined

United States v. Undetermined quantities of street drug alternatives (D. Md.) On July 10, 2001, District Court Judge Alexander Williams, Jr., signed a supplemental order of injunction in this case involving street drug alternatives manufactured and promoted by Hit Products, Inc., and Organic Diversions, Inc. The court previously issued an order of condemnation of the seized drugs and an order of permanent injunction against the defendants. Pursuant to the injunction order, the parties negotiated a consent decree with additional, more specific, relief, which the court entered as the supplemental order of injunction.

The supplemental order enjoins the defendants from introducing street drug alternatives into interstate commerce and from causing the misbranding of street drug alternatives (by, e.g., promoting the products on the defendants' Web sites) after shipment of the drugs in interstate commerce.

The order also requires the defendants to remove the meta names "marijuana," Ecstasy," "legal highs," "weed," "pot," "opium," "pipe," "bong," "hash," "shrooms," "mushrooms," "magic mushrooms," "stoner," "stoned," "baked," "marijuana grow," "drug," and "drugs," from all Web sites used by the defendants to sell products intended to be smoked, inhaled, injected or ingested. Meta names are words, invisible to an Internet user, that are embedded in computer programs by Web page designers to direct Internet users to specific Web sites.

Further, if the defendants commit future violations, the order authorizes FDA to stop the defendants' manufacturing operations. FDA is also authorized by the order to monitor the defendants' compliance by all lawful means, including conducting undercover buys without providing prior notice to the defendants.

Red Yeast Rice

Court Holds That Red Yeast Rice is a “New Drug”

Pharmanex v. Shalala (D. Utah) On March 30, 2001, The U.S. District Court for the District of Utah denied Pharmanex Inc.’s motion to Set Aside Administrative Decision, and Granted FDA’s motion to Affirm Administrative Decision, in the Cholestin matter. This matter involved a purported dietary supplement product that contained lovastatin, the active ingredient present in the prescription drug Mevacor, intended to reduce serum cholesterol levels.

On July 21, 2000, the Tenth Circuit Court of Appeals ruled in favor of FDA [See Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir. July 2000)] on legal issues, but remanded the matter back to the district court for resolution of certain factual issues. In the latest ruling, the district court affirmed the factual bases supporting FDA’s Administrative Decision that Pharmanex, in marketing Cholestin, was marketing lovastatin, an article approved as a new drug that was not [before such approval] marketed as a food or dietary supplement. This means that, under the Dietary Supplement Health and Education Act, red yeast rice containing lovastatin is regulated as a drug and not a dietary supplement.

Firm Discontinues Distribution of Red Yeast Rice Powder

On May 8, 2001, the FDA’s New York District Office issued a Warning Letter to Maypro Industries, Inc., Purchase, New York, concerning its distribution of bulk red yeast rice powder for use as an ingredient in dietary supplements. According to certificates of analysis provided by the firm, the red yeast rice powder contained greater than 0.4% lovastatin, the active ingredient in the prescription drug Mevacor.

On March 30, 2001, the U.S. District Court for the District of Utah affirmed that red yeast rice products that contain significant amounts of lovastatin are subject to regulation as drugs and are not dietary supplements. On May 17, 2001, Maypro Industries informed the agency that it had discontinued distribution of red yeast rice powder and had advised its customers of FDA's position with respect to red yeast rice powder containing lovastatin.

Warning Letters for Products Containing Red Yeast Rice

• On June 19, 2001, the FDA’s Denver District Office issued Warning Letters to Nature's Sunshine Products, Inc., Provo, Utah, and Nutraceutical International Corp., Park City, Utah, regarding the promotion and distribution of products containing lovastatin, manufactured from fermented red yeast rice. The Warning Letter noted that labels collected during an FDA inspection of the firm on February 6, 2001, bore an Internet Website address www.naturessunshine.com. The Letter noted that claims found on the Internet site caused the product to be in violation of the FD&C Act. The Nature's Sunshine product, "Cholester-Reg", contains 3 mg lovastatin, which the Nutraceutical products "KAL Cholesterol Defense," "Solaray Red Yeast Rice," and "Solaray Guggul & Red Yeast Rice" products all contain 3.6 mg lovastatin. The Warning Letters advised the firm of the District Court ruling [See Pharmanex v. Shalala (D. Utah, March 30, 2001)] that red yeast rice products which contain lovastatin are subject to regulation as drugs and are not dietary supplements.

• On June 4, 2001, the FDA’s Denver District Office issued a Warning Letter to Oralabs, Englewood, Colorado, regarding the distribution of Cholesterx, a dietary supplement containing red yeast rice extract. The rice, when fermented with red yeast, contains lovastatin, the active ingredient in prescription medications for lowering cholesterol. The letter advised the firm that such products are considered by the Agency to be drugs, not dietary supplements. The Warning Letter advised the firm that FDA’s position was affirmed by the U.S. District Court in Utah on March 20, 2001, when they dismissed a case against the Agency brought by Pharmanex, a company marketing a similar product containing red yeast rice and lovastatin.

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