All Posts Tagged Tag: ‘fda warnings’

Drug and Dietary Supplement Maker Signs Consent Decree Sought by FDA

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.Read More

FDA Increasing Enforcement Against Cosmeceuticals?

The FDA may be ramping up enforcement against cosmetics marketers the agency says are making claims that move their products out of the cosmetics category and into the drug category.  With notices sent October 5 to Avon Products and Bioque Technologies, the FDA now has issued seven warning letters since June, citing what it says are drug claims “associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites.”Read More

FDA and FTC Joint Action Aimed at Removing HCG Weight Loss Products from Market

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.

FDA and FTC Launch Joint Fraudulent STD Products Initiative

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.

FDA Warns of Serious Health Problems from Soladek Vitamin Solution

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.