Wednesday, June 25, 2014

FDA Issues Draft Guidance Regarding MDDS

The FDA has released draft guidance last Friday, stating that the agency considers medical device data systems (MDDS) to be safe and effective, and does not intend to regulate them.

According to the guidance, the FDA will not mandate compliance to controls related to MDDS, including registration, premarket review and postmarket reporting, if they do not aim to control or alter the function of any connected medical devices, but rather are intended to:

  • Facilitate electronic transfer or exchange of medical device data;
  • Store and retrieve medical device information, such as blood pressure data;
  • Convert medical device data from one format to another; and
  • Display medical device information.

Comments for the draft guidance will be accepted through August 19th.

Thursday, February 27, 2014

FDA Proposes Updates to Nutrition Facts Labels on Food Packages

The FDA proposed several changes to the Nutrition Facts label for packaged foods today.  The FDA also proposed to make corresponding updates to the Supplement Facts label on dietary supplements. 

Some of the changes being proposed by the FDA would:
  • Require information about the amount of "added sugar" in a food product.
  • Update serving size requirements to reflect the amounts people currently eat.  (For example, changing the serving size of ice cream from half a cup to a full cup.)
  • Require the declaration of potassium and vitamin D.  Vitamins A and C would no longer be required on the label.
  • Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber and vitamin D.
  • Remove "Calories from Fat" from the label.
  • Update the format to emphasize certain elements.
The FDA also published an alternative format to test public interests.   The agency is accepting public comment on the proposed changes for 90 days before the new rules being finalized .  The new rules aren't slated to take effect for at least two years.

Thursday, January 16, 2014

FDA Issues Guidance to Clarify Requirements for Beverages v. Liquid Dietary Suppelments

The FDA published two final guidance documents to help industry determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.

One of the guidances - Distinguishing Liquid Dietary Supplements from Beverages - describes the factors that characterize liquid products that are dietary supplements and those that characterize beverages that are conventional foods.  Such factors include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling and advertising.

The second guidance - Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements - reminds the industry of requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances added to both conventional foods, such as beverages, and to dietary supplements.

Why does it matter whether a food is a beverage or a dietary supplement? 

All ingredients intentionally added to conventional foods or beverages are considered food additives.  Food additives must either be approved by the FDA, deemed generally recognized as safe (GRAS), or otherwise exempted.  A company may self-affirm the GRAS status of a food ingredient in its product(s).  It is not mandatory for the company to submit a self-affirmed GRAS report to the FDA, however, it must be prepared to do so upon the FDA's request.  Further, the costs associated with GRAS determinations can run upwards of $75,000 to $100,00 per ingredient.

Ingredients in a dietary supplement, on the other hand, have different requirements.  For example, if an ingredient meets one of the definitions of dietary ingredient and was used as a dietary ingredient prior to October 1994, no additional proof of safety is required.  Therefore, many companies may have used the dietary supplement route to market their liquid food products to save money.  However, the costs associated with complying with the more stringent good manufacturing practices (GMP) for dietary supplements, as well as their added post-marketing requirements (adverse event reporting and record keeping), can make it more expensive to market a dietary supplement vs. a beverage, in the long run.

Therefore, it is important to consider all the potential costs involved for regulatory compliance when a company decides whether to include a particular ingredient in its next liquid food product.

Tuesday, January 7, 2014

FTC takes actions against makers of weight-loss products

The Federal Trade Commission (FTC) announced enforcement actions against four companies the agency said used deceptive advertising claims to sell weight-loss products.   In total, the four companies - Sensa, L'Occitane, HCG Diet Direct and LeanSpa - have agreed to pay about $34 million for consumer redress. 

The FTC has also updated guidance for publisher and broadcasters on how to spot phony weight-loss claims when screening ads for publication.  “Gut Check: A Reference Guide for Media on Spotting False Weight-Loss Claims” describes seven weight loss claims that can’t be true and should prompt a “gut check” – a second look to make sure publishers are not running advertisements with claims known to be false.  The guide also contains advice on dealing with problematic areas like consumer testimonials and fine print disclosures.  The Gut Check guidance updates the Red Flag Bogus Weight-Loss Claims reference guide for media that the FTC first published in 2003.

Sensa sold a sprinkle-on food additive that promised users would lose weight without exercising.  Users paid about $60 for one-month supply of Sensa products, which were sold online and at retail chains that included Costco and GNC.  U.S. retail sales between 2008 and 2012 totaled more than $364 million, according to the FTC.  The FTC said Sensa used faulty science in its marketing to mislead consumers and ordered the company to return $26.6 million to consumers.  The case was filed against Sensa, its parent firm, and two individuals who was chief executive and co-owner of the company.

L'Occitane, which the FTC said had no evidence to back up the claim that its skin cream would slim down a person's body, will pay $450,000.  HCG Diet Direct, which marketed a human hormone for weight-loss treatments, will surrender about $7.3 million in assets.

The fourth company, LeanSpa, which marketed acai berry and colon cleanse supplements, was granted a suspended settlement from the FTC because the company's inability to pay.

Weight-loss products remain one of the FTC's top enforcement priorities.   Makers of weight-loss products should ensure that their product claims (including testimonials used) are truthful, not misleading and supported by scientific evidence.