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FDA Issues Draft Guidelines for Notification of New Dietary Ingredients

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.

FTC Seeks to Stop Fake News Sites' Deceptive Claims About Acai Berry Weight Loss Products

The Federal Trade Commission has asked to federal courts to issue temporary restraining orders to stop 10 alleged “fake news” operations from using their Web sites to market  acai berry weight-loss products.  The FTC seeks to permanently stop these practices and has asked courts to freeze the operations’ assets pending trial.

According to the FTC, the websites that are intended to appear as if they belong to legitimate news organizations. However, the FTC maintains that the sites are simply advertisements using deceptive practices to entice consumers to buy the featured acai berry weight-loss products from other merchants.

The FTC complaints allege that the fake news sites have titles such as “News 6 News Alerts,” “Health News Health Alerts,” or “Health 5 Beat Health News.”  They often include the names and logos of major media outlets such as ABC, Fox News, CBS, CNN, USA Today, and Consumer Reports and falsely represent that the reports on the sites have been seen on these networks. 

The FTC is asking the courts to permanently bar the allegedly deceptive claims, and to require the companies to provide money for refunds to consumers who purchased the supplements and other products.  The FTC charges that the defendants:

  • make false and unsupported claims that acai berry supplements will cause rapid and substantial weight loss;
  • deceptively represent that  their websites are objective news reporters,  that independent tests demonstrate the effectiveness of the product, and that the comments following the “articles” on their websites reflect the views of independent consumers; and
  • fail to disclose their financial relationships to the merchants selling the products.

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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.

FDA Steps Up Campaign Against Tainted Dietary Supplements

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.

FTC Approves Order Settling Dannon Deceptive Claims Charges

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.

For additional detail about the settlement, see the full agreement, original FTC complaint and complaint exhibits.

Consumers Group Takes Aim at VitaminWater

Dietary supplement marketers need to be on the look-out not only for the FDA and the FTC, but for consumer protection organizations as well. Most recently, the National Consumers League sent a letter to the FTC urging the agency to take action against VitaminWater.

The NCL calls VitaminWater advertising and labelling claims “deceptive” and “dangerously misleading” and is urging the FTC to stop the manufacturer’s continued use of them.

The complaint cites VitaminWater promotions that say “flu shots are so last year,” implying, the NCL believes, that VitaminWater is being promoted as product that can replace flu shots or prevent illness.

In a television ad, a woman is shown at home watching TV instead of at work because VitaminWater helped her become healthier so that she can use unused sick days to play hooky instead of being ill.

The NCL complaint also wants the FTC to stop label statements for VitaminWater that describe the product as a “nutrient enhanced water beverage” and that claim “vitamins + water = all you need.”

According to NCL, the statements are deceptive because VitaminWater is more than just vitamins and water, but also are made with crystalline fructose or other forms of sugar, and contain 125 calories per bottle.

The FTC has not yet responded to NCL’s complaint.

FDA Announces New Actions to Stop Tainted Products Marketed as Dietary Supplements

The Food and Drug Administration has announced new steps intended to keep consumers safe from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients.

According to the FDA, these products are often promoted for weight loss, sexual enhancement, and bodybuilding.

The new steps FDA has taken include:

  • A letter from Commissioner of Food and Drugs Margaret A. Hamburg to the dietary supplement industry emphasizing its legal obligation and responsibilities to prevent tainted products from reaching the U.S. market.
  • A new rapid public notification system (RSS Feed) on its website to more quickly warn consumers about these products.
  • A mechanism for industry to alert FDA about potentially tainted products and about the firms that make them.

Among the substances found in products that are marketed as dietary supplements and that contain hidden or deceptively labeled ingredients, the FDA cites:

  • the active ingredients in FDA-approved drugs or their analogs (closely-related drugs).
  • other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

Where FDA investigations have discovered tainted products marketed as dietary supplements, the agency has issued warning letters and conducted seizures and criminal prosecutions.

FDA has also alerted consumers to hundreds of products with these often deceptively labeled and harmful ingredients, including more than 80 products marketed for sexual enhancement, more than 70 products marketed for weight loss, and more than 80 products marketed for bodybuilding.

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