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A federal judge has granted the Food & Drug Administration’s request for a permanent injunction prohibiting BioAnue from making and distributing its dietary supplement products until they comply with FDA regulations.
While BioAnue sold the products as dietary supplements, the FDA maintained that they were “unapproved new drugs” because they were marketed without FDA approval as treatments for a variety of diseases, including cancer, HIV/AIDS, heart disease and diabetes. In addition, BioAnue failed to follow the FDA’s current good manufacturing practice regulations for dietary supplements.
The Attorneys General of Oregon, Washington and Vermont each have filed suit against Living Essentials, LLC, and Innovation Ventures, LLC, the makers of 5-Hour Energy drink, alleging that advertising for the product violates their states’ consumer protection laws by making deceptive and misleading claims.
U.S. Marshals in Norcross GA, acting at the request of the FDA, seized $2 million in dietary supplements from Hi-Tech Pharmaceuticals, Inc. According to the FDA, the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent.
The Food and Drug Administration has filed a complaint seeking a permanent injunction against James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, to stop the company’s distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Oregon, Portland Division.
The FTC has filed a complaint against the marketers of the HCG Platinum dietary supplements, charging them with deceptive advertising for claiming that using the product will result in substantial weight loss.
The complaint filed in the U.S. District Court for the District of Arizona, names two corporate defendants, HCG Platinum, LLC and Right Way Nutrition, LLC, company president Kevin Wright, and seven relief defendants the FTC says received money from sales of the HGC products.
PUH, which markets products under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, and its president, Stephen J. Poindexter, have entered into a consent decree of permanent injunction sought by the Food and Drug Administration for allegedly distributing unapproved new drugs and adulterated dietary supplements.
The FDA and FTC have issued warning letters to companies marketing over-the-counter products containing human chorionic gonadotropin (HCG) hormone that are labeled “homeopathic” remedies for weight loss.
The two agencies say the joint action is the first step in keeping these products from being marketed online and in retail outlets.
HCG is FDA-approved as a prescription drug for the treatment of some cases of female infertility and other medical conditions, but is not approved for weight loss. The letters warn the companies that they are not only in violation of federal law by selling unapproved drugs, but that they are making unsupported weight loss claims.
The labeling for the “homeopathic” HCG products states that they should be taken in conjunction with a very low calorie diet. According to the FTC, the weight loss claims are deceptive since there is no substantial scientific evidence that HCG increases weight loss beyond that resulting from the calorie-restricted diet. In addition, the FDA says that people on very low calorie diets may be at risk for a number of harmful side effects and should only use such diets under medical supervision.
According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
U.S. Marshals at the request of the FDA have seized raw materials from Infinity Marketing Group, Inc. containing ephedrine alkaloids, ingredients banned by FDA since 2004 for use in dietary supplements.
The seized materials, more than 4,000 pounds of ephedrine alkaloid-containing raw material – Cissus quadrangularis and Cassia angustifolia extracts – were valued at $70,000.
Ephedrine alkaloids are adrenaline-like stimulants that are potentially dangerous effects to the heart. Before 2004, ephedrine alkaloids had been used extensively in dietary supplements promoted for aiding weight control and boosting sports performance and energy. However, available data showed little evidence of ephedrine’s effectiveness. There could be a modest, short-term weight loss, but that was without any clear health benefit. Yet the alkaloid raised blood pressure and otherwise stressed the circulatory system, effects tied to heart attack, stroke and death.
On the Wednesday before Thanksgiving, the FDA gave the owners of ATF Fitness Products, Inc. (ATF) and Manufacturing ATF Dedicated Excellence, Inc. (MADE) little to be thankful for. On that day, the Justice Department, on behalf of the FDA, filed legal action against the Oakmont, Pennsylvania companies seeking a permanent injunction that would stop them from manufacturing and distributing over 400 different dietary supplement products.
The action was based on alleged violations by ATF and MADE of the current Good Manufacturing Practice (cGMP) regulations for the manufacture of dietary supplements. According to the Complaint filed by the Justice Department, ATF is the sole distributor of dietary supplement products manufactured by MADE. Also named in the complaint is James G. Vercelotti, the owner and operator of both entities.
Under the cGMPs for dietary supplements (found at 21 C.F.R. § 111), dietary supplements must be manufactured according to processes that incorporate controls in the design and production process to assure a quality finished product. The purpose of the cGMPs for dietary supplements is to ensure quality and safety. According to the Complaint, ATF and MADE failed to adhere to the cGMPs in the manufacture of over 400 dietary supplement products. The Complaint alleges a number of deviations from the cGMPs at pages 3 through 5 of the Complaint. You can access the Complaint here.
In addition to the alleged deviations from the cGMPs, the Complaint alleges that the defendants misbranded their dietary supplement products by substituting ingredients for those listed on the product labels. Finally, the Complaint alleges that the defendants failed to submit Serious Adverse Event reports to the FDA as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (21 U.S.C. §§ 379aa – 379aa-1). As an example of this failure, the Complaint alleges that the defendants received a report of a serious adverse event from a consumer who claimed that one of their products caused a high blood pressure spike requiring hospitalization and subsequently caused a mild heart attack. The defendants failed to submit a report of this event to the FDA as required by the Act.
According to the press release issued by the FDA, this is the first time that the agency has sought a permanent injunction against a dietary supplement manufacturer of this size.
Just last week, the Food & Drug Administration issued draft guidelines for when manufacturers and distributors of dietary supplements need to notify the FDA of so called “new dietary ingredients” and to provide the agency with evidence of the safety of the ingredient. The requirement to provide the FDA with notification of new dietary ingredients and evidence of their safety has been around since the Dietary Supplement Health and Education Act (“DSHEA”) was enacted in 1994. However, it appears that there has been a substantial lack of compliance with this legal requirement. According to various media reports, the FDA has received around 700 such notifications since the law went into effect in 1994. Additionally, a law enacted just this past January (the FDA Food Safety Modernization Act) required FDA to issue the guidelines.
Under DSHEA, a manufacturer or distributor of a dietary supplement that contains a new dietary ingredient must provide FDA with pre-market notification of the new dietary ingredient together with “information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.” Where such notification is required, it must be given at least 75 days before the product is introduced into interstate commerce. If this is not done, the dietary supplement will be deemed to be adulterated.
So now, you are probably asking what is a “new dietary ingredient”? A new dietary ingredient is a dietary ingredient (a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the foregoing dietary ingredients) that was not marketed in the United States in a dietary supplement before October 15, 1994. Note that the pre-market notification described above is not required if the new dietary ingredient has been “present in the food supply as an article used for food in a form in which the food has not been chemically altered.” In other words, the pre-market notification will not be necessary if the new dietary ingredient (a dietary ingredient that was not present in a dietary supplement in the U.S. prior to October 15, 1994) is derived from something that was in the food supply of the U.S. prior to that date and has not been chemically altered.
Because this is all somewhat confusing, the FDA has prepared the draft guidance, which you can view here. The draft guidance answers questions in a FAQ format to assist manufacturers and distributors in determining whether they need to file the pre-market notification and evidence of safety. It also contains templates for the preparation of a new dietary ingredient pre-market notification. In addition, if you are so inclined, you can even comment on the draft guidance, although in order for your comments to be considered by the FDA, they must be filed within 90 days of the date that the notification was published in the Federal Register. The notification was published on July 5, 2011—see here.
FDA hopes that with the publication of these guidelines that compliance with the pre-market notification requirements will improve. Only time will tell.