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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.
Facebook has agreed to settle FTC charges that it deceived consumers by telling them they could keep their information on Facebook private, and then repeatedly allowing it to be shared and made public. The eight-count complaint charges that the claims were unfair and deceptive, and violated federal law.
Similar to the recent Google Buzz privacy settlement, the proposed Facebook settlement requires the social networking company to take specific steps to ensure it lives up to its privacy promises, including giving consumers clear and prominent notice and obtaining the user’s express consent before their information is shared beyond the privacy settings the user has established.
Facebook also will be required, for the next 20 years, to obtain independent, third-party audits certifying that it has a privacy program in place that meets or exceeds the requirements of the FTC order, as well as to ensure that the privacy of consumers’ information is protected.
The proposed settlement also
- bars Facebook from making misrepresentations about the privacy or security of user’s personal information.
- requires Facebook to obtain a user’s express consent before effecting changes that override their privacy preferences.
- requires Facebook to prevent anyone from accessing a user’s material more than 30 days after the user has deleted the account.
- requires Facebook to establish and maintain a comprehensive privacy program designed to address privacy risks associated with the development and management of new and existing products and services, and to protect the privacy and confidentiality of users’ information.
- requires Facebook within 180 days, and every two years after that for the next 20 years, to obtain independent, third-party audits certifying that it has a privacy program in place that meets or exceeds the requirements of the FTC order, and to ensure that the privacy of consumers’ information is protected.
Among the instances cited in the complaint where allegedly made promises that it did not keep:
- In December 2009, Facebook made changes that allowed made public certain information that users may have designated as private without warning users of the change or getting their approval in advance.
- Facebook represented that third-party apps that users’ installed would have access only to user information that they needed to operate. In fact, the apps could access nearly all of users’ personal data – data the apps didn’t need.
- Facebook told users they could restrict sharing of data to limited audiences – for example with “Friends Only.” In fact, selecting “Friends Only” did not prevent their information from being shared with third-party applications their friends used.
- Facebook promised users that it would not share their personal information with advertisers when in fact, it did.