Crack Down by FDA on Dangerous Dietary Supplements

Make Sure Your Experts Are Thoroughly Prepped for Their Depositions

 Dietary Supplements
There is a crack down on dangerous dietary supplements by the federal government’s regulatory agency, the FDA, due to potentially unsafe or tainted supplements.  The crack down was so significant that it resulted in ciivil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Recently the FDA announced they are purusing a criminal case against USPlabs LLC and several of its corporate officers. The case against USPlabs, LLC was not only led by the FDA, but also by the U.S. Department of Justice, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense, and the U.S. Anti-Doping Agency.   The government has an 11-count indictment against USPlabs which formerly manufactured highly popular workout and weight loss supplements. The indictment charges USPlabs, S.K. Laboratories Inc. and their operators with a variety of charges related to the sale of those products.  The indictment alleges that USPlabs engaged in a conspiracy to bring ingredients from China using fake certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.  USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory, according to the indictment. The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, the defendants knew of studies that linked the products to liver toxicity. It is also alleged that USPlabs and its principals told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries. Despite this promise, USPLabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations an policy released a statement regarding the case.  “This joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely marketed as dietary supplements.  The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to protect Americans and bring justice.”
Also, the DOJ announced it filed a complaint against Bethel Nutritional Consulting Inc. of New York and New Jersey and the company’s president and vice-president. According to the complaint, Bethel and its officers distributed adulterated and misbranded dietary supplements and unapproved new drugs throughout the United States. The defendants have agreed to stop operations until the FDA determines that they are in compliance with laws applicable to dietary supplement manufacturing, labeling, and distribution.  FDA inspections of Bethel’s operations revealed deviations from current good manufacturing practice regulations, resulting in altered dietary supplements, and deviations from labeling requirements, causing the dietary supplements to be misbranded.  The FDA has also determined that Bethel distributed unapproved new drugs, because the company made medical claims that certain dietary supplement products were intended to cure, mitigate, treat, or prevent diseases, or to affect the structure or function of the body.  Additionally, certain tproducts falsely marketed as dietary supplements by Bethel contained potentially harmful active pharmaceutical ingredients, including sibutramine and lorcaserin. Sibutramine was an active pharmaceutical ingredient in Meridia, a drug approved by the FDA in 1997 for prescription treatment of obesity. Meridia was removed from the market in 2010 because of risks of serious adverse cardiovascular events, including heart attack and stroke. Lorcaserin is the active pharmaceutical ingredient in Belviq, a drug approved by the FDA in 2012 for chronic weight management in some overweight or obese adults. Lorcaserin may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Lorcaserin may also cause disturbances in attention or memory.
The FDA continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss and body building. Within the last year, the FDA also sent warning letters to manufacturers selling dietary supplements that contain BMPEA and DMBA, two ingredients that do not meet the statutory definition of a dietary ingredient as well as to several companies selling pure powdered caffeine products that the agency determined to be dangerous and present a significant or unreasonable risk of illness or injury to consumers.
So what you should do before taking a dietary supplement? Be aware and have knowledge of what you are taking.  Supplements are most likely to cause side effects or harm when people take them instead of prescribed medicines or when people take many supplements in combination. Some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person’s response to anesthesia. Dietary supplements can also interact with certain prescription drugs in ways that might cause problems. Here are just a few examples:

  • Vitamin K can reduce the ability of the blood thinner Coumadin® to prevent blood from clotting.
  • St. John’s wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs’ effectiveness.
  • Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.

Keep in mind that some ingredients found in dietary supplements are added to a growing number of foods, including breakfast cereals and beverages. As a result, you may be getting more of these ingredients than you think, and more might not be better. Taking more than you need is always more expensive and can also raise your risk of experiencing side effects. For example, getting too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.
Be cautious about taking dietary supplements if you are pregnant or nursing. Also, be careful about giving them (beyond a basic multivitamin/mineral product) to a child. Most dietary supplements have not been well tested for safety in pregnant women, nursing mothers, or children.
If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088 or completing a form onlineexternal link disclaimer. In addition, report your reaction to the dietary supplement company by using the contact information on the product label.

Keep in Mind

Don’t decide to take dietary supplements to treat a health condition that you have diagnosed yourself, without consulting a health care provider.

  • Don’t take supplements in place of, or in combination with, prescribed medications without your health care provider’s approval.
  • Check with your health care provider about the supplements you take if you are scheduled to have any type of surgical procedure.
  • The term “natural” doesn’t always mean safe. A supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used. Certain herbs (for example, comfrey and kava) can harm the liver.
  • Before taking a dietary supplement, ask yourself these questions: ◦What are the potential health benefits of this dietary supplement product?

◦What are its potential benefits for me?
◦Does this product have any safety risks?
◦What is the proper dose to take?
◦How, when, and for how long should I take it?
If you don’t know the answers to these questions, use the information sources listed in this brochure and talk to your health care providers.
Overall, talk with your Health Care Provider.  Let them know which dietary supplements you’re taking so that you can discuss what’s best for your overall health. Your health care provider can help you determine which supplements, if any, might be valuable for you.
Keep a record of the supplements you take in one place, just as you should be doing for all of your medicines. Note the specific product name, the dose you take, how often you take it, and the reason why you use each one. You can also bring the products you use with you when you see your health care provider.
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