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. (more…)
Posts Tagged ‘fda’
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.
In a relatively rare joint-agency action, the Federal Trade Commission and the Food and Drug Administration have launched the “Fraudulent STD Products Initiative,” to identify and remove over-the-counter products that make unproven claims to prevent, cure, and/or treat sexually transmitted diseases (STDs).
The products targeted have not been evaluated by the FDA for safety and effectiveness and may pose significant public health risk since they could delay proper medical treatment and help spread disease.
In the first step of the initiative, FDA and FTC have “co-signed” warning letters to manufacturers and others involved in the marketing of the fraudulent STD products. The letters list specific violations of FDA and FTC regulations, and the two agencies will monitor the responses and take additional action as needed to ensure enforcement. Among the products targeted are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak.
The companies that received the warning letters claim that their products treat a range of STDs, including herpes, chlamydia, genital warts, HIV, and AIDS. Some of the products are marketed as dietary supplements, but since they are being sold to treat disease, the FDA considers them all drug products that fall under the jurisdiction of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and cannot be sold through interstate commerce without an FDA-approved new drug application.
On the FTC side of the initiative, FTC considers the marketing of the products a “scam” utilizing deceptive advertising practices. They are being advertised as offering health benefits that are not supported by scientific evidence and thus violate the FTC act.
Risk of serious health problems from dangerously high levels of vitamins A and D
After receiving seven reports of serious health problems in people using Soladek vitamin solution, the FDA is warning people The FDA is telling consumers to stop using the product.
Marketed by Indo Pharma, S.A. of the Dominican Republic company of the Dominican Republic, the FDA believes Soladek may contain dangerously high levels of vitamins A and D.
Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.
The problems reported include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.
Soladek, sold in a box labeled in Spanish and containing a vial of the solution, is marketed with claims that the product treats various diseases and conditions. It cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA.
However, the reports of adverse events and other information has led the FDA to conclude that Soladek may be available illegally in the country and therefore issued the warning.
The FDA has stepped up its campaign against tainted and otherwise dangerous dietary supplements that so far has identified 300 fraudulent products.
These products, typically promoted as “safe” supplements for weight loss, sexual enhancement and bodybuilding, are deceptively labeled or contain hidden or deceptively labeled ingredients that can cause a variety of serious conditions, including stroke, liver injury, kidney failure, heart palpitations and death.
The illegal ingredients include the active ingredients in FDA-approved drugs, sometimes prescription drugs, or other compounds, such as synthetic steroids, that do not qualify as dietary supplement ingredients.
While dietary supplements typically do not require FDA approval, the marketing companies are responsible for ensuring both the safety of their products and that their marketing claims are true. And while it is easier for a product to come to market than for the FDA to take it off the market, the situation with tainted products is serious and commonplace enough for the FDA to step up enforcement activities.
The FDA started this enhanced program in December 2010. In addition to consumer alerts and press announcements about these products to warn consumers, the FDA issues warning letters, seizes products and conducts criminal prosecutions.
In December, for example, a woman pleaded guilty to an 18-count indictment charging her with the illegal importation and distribution of more than four million diet pills that contained a controlled substance, unapproved drugs and a possible cancer-causing agent.
Following a public comment period, the Federal Trade Commission voted 5-0 to finalize the order settling charges that Dannon exaggerated the health benefits of its Activia yogurt and DanActive dairy drink, two products that contain beneficial bacteria known as probiotics.
Under the settlement, Dannon agreed to stop claiming that Activia relieves temporary irregularity, unless the representation is non-misleading and the ad conveys that eating three servings a day is required to benefit, or unless Dannon has competent and reliable scientific evidence that the benefit can be achieved from eating less than three servings a day.
Dannon also agreed to stop claiming that DanActive or any yogurt, dairy drink or probiotic food helps people avoid catching colds or flu, unless the claim is approved by the FDA.
While the FTC has settled part of its case against POM Wonderful with the consent order with Mark Dreher, the former POM Wonderful LLC Vice President of Science and Regulatory Affairs, the company itself continues to fight the FTC with its lawsuit claiming the regulator is violating POM Wonderful’s First Amendment rights.
The latest salvo came mid-January when POM Wonderful’s lawyers filed a request that the federal district court in Washington DC dismiss the FTC’s suit. The company’s position is that it does not make any specific health claims. Rather, it is only communicating the promising results of its research.
According to a POM Wonderful statement, “We believe the commission is acting beyond its jurisdiction, exceeding its authority, and creating a new regulatory scheme that attempts to treat our juice as a drug, which it is not. The FTC is violating POM’s constitutional rights to share useful and important information with the public, and therefore we have initiated a separate lawsuit to preserve these rights.”
POM Wonderful’s belief is that their product is a food about which they are reporting the promising results of research studies. The FTC contends they are misrepresenting the studies to make claims about the health benefits of their products.
In that, the FTC has the support of the FDA, which in February, 2010, sent a warning letter to POM Wonderful stating that that the FDA found “serious violations of the Federal Food, Drug, and Cosmetic Act” and “determined that your POM Wonderful 100% Pomegranate Juice product is promoted for conditions that cause the product to be a drug.”
POM Wonderful’s response to that is the same as to the FTC complaint: “We believe that the manner of which we have communicated the results of our scientific research is both truthful and appropriate.”