Regulatory Focus™ > News Articles > Weighty Matters: Warning Letter Cites Rare Labeling Omission

Weighty Matters: Warning Letter Cites Rare Labeling Omission

Posted 04 March 2014 | By Alexander Gaffney, RAC

Warning Letters, sent by the US Food and Drug Administration (FDA) to companies that have fallen afoul of federal regulations, are often a good way learn what you should absolutely not be doing.

Case in point: a December 2013 Warning Letter to a dietary supplement manufacturer in which FDA inspectors allege that the company didn't seem to be verifying the identity of its raw ingredients, leaving open the possibility that the end manufactured product might be deficient in quality.

That, however, is a fairly common violation as far as Warning Letters go. FDA has sent dozens of letters on the subject in just the last five years.

But what Warning Letters can also do is provide insight into some of the less-common violations seen under the Federal Food Drug and Cosmetic Act (FD&C Act), the backbone of FDA's regulatory power.

Dive deep into that same December 2013 Warning Letter and you'll find a curious violation under 21 CFR 101.105(j)(3), a regulation which covers food labeling. As dietary supplements are technically food products, they are bound by food labeling regulations, and must do the following:

(j) On packages containing less than 4 pounds or 1 gallon and labeled in terms of weight or fluid measure:

 (3) The declaration may appear in more than one line. The term "net weight" shall be used when stating the net quantity of contents in terms of weight. Use of the terms "net" or "net contents" in terms of fluid measure or numerical count is optional. It is sufficient to distinguish avoirdupois ounce from fluid ounce through association of terms; for example, "Net wt. 6 oz" or "6 oz Net wt." and "6 fl oz" or "Net contents 6 fl oz".

The problem with Health Breakthrough International's products, including MPS Gold 100, was that they left out that crucial wording. A photo of the product shows it as listing "122.40 grams (4.3 ounce)" on the front of the product. However, it is unclear if that is the weight of the product, the weight of the product and its packaging, or simply the manufacturer's favorite number.

But for these two omitted words on the label, it would not have been a problem, FDA said.

According to records, FDA has only twice before cited supplement manufacturers for this omission: Once in 2006, and again in February 2013.


FDA Warning Letter  to Health Breakthrough International

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