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  4. CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug Use
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GUIDANCE DOCUMENT

CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug Use March 1995

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

BACKGROUND:

Pangamic acid has been promoted both as a dietary supplement and as a drug. Information available to us indicates that there has been no identity established for a substance characterized by the name pangamic acid (or "vitamin B-15"). The chemical structure and nature of such a substance has not been definitely determined. In addition, we are not aware of any accepted scientific evidence which establishes the nutritional properties of pangamic acid or which has identified a deficiency of this substance in man or animals. We are also unaware of a suitable specific analytical method for its determination. A similar product, containing a mixture of calcium gluconate and dimethyl glycene, has been promoted as the building blocks of "calcium pangamate," a salt of the so-called Vitamin B-15.

POLICY:

The Act defines the term "drug" in part as "... articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals ...." *Pangamic acid has historically been promoted as a treatment for cancer, along with other disease conditions.* If pangamic acid is offered for such purposes, it would be considered a drug and require clearance under the new drug provisions of the Act. Since pangamic acid has no approved new drug application it must also be considered a new drug without an approved new drug application.

REGULATORY ACTION GUIDANCE:

  1. Domestic - Recommend legal action to *Division of Drug Labeling Compliance (HFD-310) on all pangamic acid products with accompanying labeling containing disease claims* (including products containing dimethyl glycine mixed with other compounds such as calcium gluconate) or on the manufacturer, packer, or distributor, in accordance with the following principles:

     

    1. Seizure - Recommend open-ended seizures as the primary initial action against *manufacturers*, major repackers and distributors.

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    2. Injunction - Recommended injunction

      When follow-up to open-ended seizures reveals that a *manufacturer, major* repacker or distributor is continuing to distribute *pangamic acid labeled as drugs*. Injunction may be recommended by using established procedures or by amending the complaint for forfeiture, whichever is appropriate.

    3. Criminal Contempt - Recommend criminal contempt when follow-up investigation reveals violation of the injunction.

      SPECIMEN CHARGES:

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      Drug Charge: The article is a drug within the meaning of 21 U.S.C. 321(p) which, pursuant to 21 U.S.C. 355(a), may not be introduced or delivered for introduction into interstates commerce since it is a "New Dug" within the meaning of 21 U.S.C. 321(p), and no approval of an application filed pursuant to 21 U.S.C. 355(b) is in effect for the drug.

  2. Imports

    Detain imports of pangamic acid products offered as a drug.

    SPECIMEN CHARGES:

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    Drug Charge: The article is violative within the meaning of 21 U.S.C. 381(a)(3) in that it appears to be a new drug within the meaning of 21 U.S.C. 321(p) for which no approval of an application filed pursuant to 21 U.S.C. 355(b) Is in effect for such drug.

NOTE: The regulatory action criteria do not apply to dimethyl glycine, when labeled as such and offered as a single ingredient compound for food use only.

***This CPG is Under Review***

*Material between asterisks is new or revised*
<> Indicates material has been deleted

Issued: 10/20/76
Reissued: 10/1/80
Revised: 9/1/83, 10/13/89, 3/95

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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