Sec. 140.100 Seizure of Books that Constitute Misleading Labeling (CPG 7153.13)

BACKGROUND:

For many years, the agency has recommended the seizure not only of violative articles but also the labeling which causes them to be violative.

Printed material that promotes the use of a product is labeling within the meaning of the Act. In order to be labeling, the printed material must "accompany" the product in any one of several ways which have been well established by the courts. Although all accompanying materials constitute labeling, the extent to which they "accompany" it may be direct or indirect. For example, some printed material may consist of a printed sheet bearing the name of a particular product, stating its intended uses and directions for use, and naming the manufacturer and/or distributor. Some printed material may contain statements about several products, which statements occupy a reasonably small portion of the material, for example, one chapter in a book of twenty chapters. Additionally, this labeling may be printed not on behalf of the manufacturer or distributor of a product but by an unrelated publishing company, and may be sold routinely in book stores as well as in certain locations where its association with a product evidences the fact that it is labeling.

Over the years, courts have condemned and ordered destroyed labeling that was seized along with the product. In three cases, a claimant challenged the court's authority under the Act to seize, condemn and destroy labeling, arguing that these actions are contrary to the free speech protections of the first amendment. The courts have rejected these challenges although one court overturned the seizure of books displayed near a violative article by concluding that the books were not labeling, in that they did not "accompany" the article, rather than by reaching the first amendment issue.

In 1976, the Supreme Court extended certain free speech protections of the first amendment to what the court called "commercial speech" which includes printed material. Such speech consists of proposing or promoting a commercial transaction by, among other things, extolling the benefit of a particular product. Notwithstanding certain free speech protections, labeling including books can be regulated if it is false or misleading.

In addition to establishing certain judicial protections for commercial speech, the courts have established that speech, including commercial speech, should not be subject to a prior restraint. A prior restraint exists where the dissemination of certain speech is restricted or prohibited before its violative nature has been judicially determined. The authority provided by section 304 of the Act to seize without a prior hearing may be argued to be an unconstitutional prior restraint.

POLICY:

Where labeling other than books renders a product to be violative, and the labeling is closely associated with the product in question *(e.g. brand name, proximity at point of sale)* the agency will continue to recommend seizure of both the product and the labeling.

Where labeling is in the form of a book and the agency believes that the use of the book to promote the product creates a significant consumer deception, the agency will consider filing a complaint for forfeiture *against the product and an injunction to halt, after a hearing, the misuse of the book.*

*Material between asterisks is new or revised*

Issued: 12/1/82
Revised: 8/31/89

Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels (CPG 7150.17)

BACKGROUND:

The Metric Conversion Act of 1975 (80 stat 1007) was enacted to voluntarily increase the use of the metric system of weights and measures in the United States. In support of this policy, the agency has developed the following guidance on the use of the metric system in declaring the net quantity of contents on the labels of FDA-regulated commodities.

This guide establishes general and specific guidance for the voluntary use of metric units of quantity to state the net quantity of contents on the labeling, including the principal display panel, of an FDA-regulated commodity.

POLICY:

1. A metric declaration of quantity of contents is not considered to be "other printed label information" that would be subject to the separation requirements of 21 CFR 101.105(f), 201.62(e), 501.105(f), 701.13(f), and 801.62(e).

2. On packages of foods labeled in English, with an alternate principal display panel in a foreign language, FDA does not object to the foreign language panel bearing only a metric declaration of net contents. This assumes, of course, that the container labeling otherwise complies fully with the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations promulgated thereunder.

3. Labeling requirements for over-the-counter drugs (21 CFR 201.62(l)) provide for use of the "mcg", "l", "ml", "cm3" symbols instead of the "ug", "L". "mL" and "cm3" symbols recommended in this guide. However, FDA will not take regulatory action if a label for an over-the-counter drug bears the symbols recommended in this guide, rather than the symbols stated in 21 CFR 201.62(l).

SUPPLEMENTAL GUIDANCE:

The principles suggested here do not convey legal requirements, but those preparing labeling may rely on these principles as acceptable to FDA.

1. Definitions

A. Metric system - The International System of Units (from the French "Le Systeme International d'Unites"), as modified for use in the United States by the Secretary of Commerce . The acronym "SI" is used to refer to this metric system. A list of SI units appropriate for declarations of quantity of contents appears in section B. A complete list of SI units and other information concerning the metric system can be found in Federal Standard 376A. This standard can be purchased from the General Services Administration, Specification Unit (WFSIS), 7th and D Streets, S.W., Room 6039, Washington D.C. 20407. Also helpful in using the metric system is the Metric Editorial Guide, 4th edition, by the American National Metric Council, 1010 Vermont Avenue, N.W., Suite 320, Washington, D.C. 20015.

B. Inch-pound units - Units based upon the yard and the pound commonly used in the United States and defined by the National *Institute for* Standards *Technology.* (Units having the same names in other countries may differ in magnitude).

2. SI Unit Prefixes

A. The following chart (excerpted from the Metric Editorial Guide) indicates SI unit prefixes that may be used on a broad range of consumer commodity labels:

              SI UNIT PREFIXES 

Multiplication 

Factor       Prefix   Symbol  Term (USA)  
10[sup]18       exa     E      one quintillion 
10[sup]15       peta    P      one quadrillion 
10[sup]12       tera    T      one trillion 
10[sup]9        giga    G      one billion 
10[sup]6        mega    M      one million 
10[sup]3        kilo    k      one thousand 
10[sup]2        hecto   h      one hundred 
10              deka    da     ten 
10[sup]-1       deci    d      one tenth 
10[sup]-2       centi   c      one hundreth 
10[sup]-3       milli   m      one thousandth 
10[sup]-6       micro   u      one millionth 
10[sup]-9       nano    n      one billionth 
10[sup]-12      pico    p      one trillionth 
10[sup]-15      femto   f      one quadrillionth 
10[sup]-18      atto    a      one quintillionth

B. In symbols or names for units having prefixes, no space is left between letters making up the symbol or the name.

Examples: mL, milliliter; mm, millimeter

C. Prefixes chosen should result in

(1) numerical values between 0.1 and 1000,and(2) decimal fractions of no more than two places.

3. Units

A. Unless FDA advises otherwise, a declaration of quantity of contents:

(1) In units of weight, is expressed in terms of the kilogram, gram, milligram, or microgram.

(2) In units of liquid measure, is expressed in terms of the liter or milliliter at 20 ^oC, except for:

• petroleum products, the declaration expresses the volume at 15 ^oC,
  
• a commodity that is normally sold and consumed while frozen, the declaration expresses the volume at the frozen temperature, and
  
• a commodity that is normally sold in the refrigerated state, the declaration expresses the volume at 4 ^oC.

(3) In units of linear measure, is expressed in terms of the meter, centimeter, or millimeter.

(4) In units of area measure, is expressed in terms of the square meter or square centimeter.

(5) In units of volume other than liquid measure, is expressed in terms of the liter and milliliter, except that the terms cubic meter and cubic centimeter are used only when specifically designated as a method of sale.

B. A number of foreign countries use "re" rather than "er" spellings for the ending of metric units of measure (e.g., metre, litre, etc.). The "er" spellings are preferred for all products sold in the U.S. FDA suggests that firms using "re" spellings revise their labels to contain "er" spellings as their labels are reprinted.

C. Unit names, including prefixes, are not capitalized except at the beginning of a sentence and in titles, headings, and other instances in which all main words are capitalized.

D. A space is left between a numeral and the unit name or symbol to which it refers.

Examples: 22 mg, 22 mL

E. The decimal marker is a dot on the line. (This is the practice in the United States and Canada; however, many countries use a comma or a raised dot).

F. Decimal notation is preferred with metric measurements, but simple fractions are acceptable, such as those where the denominator is 2, 4, and 8. A fraction should be reduced to its lowest terms.

G. A zero before the decimal point should be used in numbers between 1 and - 1 to prevent the possibility that a faint decimal point will be overlooked.

Example: The oral expression "point seven five" is written 0.75

4. Symbols

A. The following symbols for metric units are used in the declaration of quantity:

kilogram   kg     meter             m
gram       g      centimeter        cm
milligram  mg     millimeter        mm
microgram  ug     square meter      m2
liter      L      square centimeter cm2
milliliter mL     cubic meter       m3 
  cubic centimeter  cm3 

B. Symbols, except for liter, are not capitalized unless the unit is derived from a proper name. Periods should not be used after the symbol. Symbols for units are the same in singular and plural. 

Example: 1 m, 100 m

C. The "L" symbol for liter and "mL" symbol for milliliter are preferred. FDA suggests that firms using "l" and "ml" symbols revise their labels to contain "L" and "mL" symbols as their labels are reprinted.

5. Calculations

A. Conversion - The following conversion factors should be used to determine metric equivalents from inch-pound units (factors are excerpted from Federal Standard 376A):

     Length

Convert     To          Multiplied by:
inch        meter(m)    0.025 4
foot        meter(m)    0.304 8
yard        meter(m)    0.914 4

     Area 

Convert     To      Multiplied by:
sq         inch centimeter2 (cm2)  6.451 6
sq         foot meter2 (m2)        0.092 903 04
sq         yard meter2 (m2)        0.836 127 4

     Volume 

Convert       To          Multiplied by:
fluid oz      liter (L)   0.029 573 53
pt (liquid)   liter (L)   0.473 176 5
qt (liquid)   liter (L)   0.946 352 9
gal (liquid)  liter (L)   3.785 412
cubic foot    liter (L)  28.31 6 85
bushel        liter (L)  35.23 9 07

      Mass(weight

Convert               To               Multiplied by:
grain milligram (mg)   64.798 91
ounce (avoirdupois)   kilogram(kg)      0.028 349 52

pound (avoirdupois)   kilogram(kg)      0.453 592 37

B. Rounding - When the digits to be discarded begin with a 5 or more, increase by one unit the last digit retained.

Example: 8.3745, if rounded to three digits, would be 8.37; 8.3745, if rounded to four digits, would be 8.375

C. Significant digits - Consider significant digits when converting and rounding inch-pound units to metric units. Significant digits as defined by the American Heritage Dictionary are "digits of the decimal form of a number beginning with the leftmost nonzero digit and extending to the right to include all digits warranted by the accuracy of measuring devices used to obtain the numbers." Although zero digits at the beginning of a number (e.g., 0.1, 0.01) are never significant digits, zero digits at the end of a number (e.g., 0.10, 10, 10 000) may be significant digits if the digit is known to be reasonably reliable. The Metric Editorial Guide advises that "Zeros at the end of a number are not considered significant unless their use results in a number that is closer to the true value than would be the case if the number were increased or decreased by 1." The position of a decimal point in a number does not affect the number of significant digits in that number (e.g., the number 2834, 28.34, and 0.002 834 all have four significant digits.

The Metric Editorial Guide provides the following rules concerning significant digits:

(1) If the first significant digit of the metric value is EQUAL TO OR LARGER than the first significant digit of the inch-pound value, round the metric value to the SAME NUMBER of significant digits as there are in the inch-pound value.

Examples: (1st significant figures underlined):

15 oz x 0.028 349 52 kg/oz = 0.425 24
8 kg which rounds to 0.43 kg
15 fl oz x 0.029 573 53 L/fl oz = 0.443
602 95 L which rounds to 0.44 L

(2) If the first significant digit of the metric value is SMALLER than the first significant digit of the inch-pound value, round the metric value to ONE MORE significant digit than is in the inch-pound value.

Examples: (1st significant digit underlined):

65 fl oz x 0.029 573 53 L/fl oz = 1.922 279 4 L which rounds to 1.92 L

8 ft x 0.304 8 m/ft - 2.4384 m which rounds to 2.4 m

(3) The above rules do not eliminate the necessity for using good judgment. If you believe that a dimension given as 8 ft is valid to the nearest 1/10 inch, you should consider it to mean 96.0 inches and treat it as having 3 significant digits. The rounded dimension would then be 2.438 instead of 2.4 m.

6. Placement

A. When a metric declaration of quantity of contents appears on a principal display panel (PDP) of an FDA-regulated commodity within the bottom 30 percent of the area of the PDP, the metric declaration should be placed with the required inch-pound declaration of net quantity of contents.

B. A metric declaration in the bottom 30 percent of PDP may appear as the primary declaration of quantity of contents on the PDP. This metric declaration may appear above or below or to the left or the right of the inch-pound declaration of quantity. The inch-pound declaration of quantity should not be omitted from the PDP. However, on an alternate PDP that serves solely as a foreign language PDP, FDA does not object to the foreign language PDP bearing only a metric declaration of net contents. This assumes, of course, that the container labeling otherwise complies fully with the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations promulgated thereunder.

C. A metric declaration in the bottom 30 percent of PDP should comply with all provisions of FDA regulations (e.g., 21 CFR 101.105 (foods), 21 CFR 201.62 (drugs), 21 CFR 501.105 (animal food), 21 CFR 701.13 (cosmetics) and 21 CFR 801.62 (medical devices) pertaining to the required inch-pound declaration of net quantity of contents, except for provisions pertaining to a statement of count or dual statement of count or a dual statement of quantity. Manufacturers should exercise care to assure that the combined inch-pound/metric declaration complies with all location, separation, and type size requirements of the regulations and with the principles set forth in this guide. Because lower case letters are required for most metric symbols, care must be exercised to insure that both upper and lower case letters meet all letter height requirements. In lieu of the symbol, the full name of metric unit may be used, e.g., "GRAM" or "gram" or;, provided the lower case letters meet the type size requirements. Exponents should be one-half the type size of the symbol letters used.

D. Use the term "Net Weight" or "Net Wt" whenever the required declaration of net quantity of contents is in terms of weight. The metric declaration may be placed before or after such terms.

E. Whenever the required declaration of net quantity of contents is in terms of fluid measure or numerical count, the terms "net" or "Net Contents" may be used in the declaration. The metric declaration may be placed before or after such terms.

F. Always use parentheses for the second expression of a dual inch-pound declaration (e.g., net weight 24 oz (1 lb 8 oz)). Additional parentheses should be used when the metric and U.S. customary declarations appear on one line.

G. Examples of inch-pound/metric declarations:

(1) Net Wt 425 g (15 oz) or Net Weight 15 oz (425 g) (assumes ounces are known to 3 significant digits, i.e., 15.0 oz)

(2) Net Wt 680 g (24 oz) (l lb 8 oz) or Net Weight 680 g (24 oz (1 lb 8 oz)) or Net Wt 24 oz (l lb 8 oz) 680 g or NET WEIGHT (680 g) 24 oz (1 lb 8 oz) (assumes ounces are known to 3 significant digits, i.e., 24.0 oz)

(3) 1 L (33.8 fl oz) (1 qt 1.8 oz) or 1 L (33.8 fl oz (1 qt 1.8 oz)) Net or Net Contents 33.8 fl oz (1 qt 1.8 oz) 1 L

*Material between asterisks is new or revised*

Issued: 4/1/87
Revised: 3/95

Sub Chapter 150 Laboratory/Analytic

Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis (CPG 7150.18)

BACKGROUND:

FDA occasionally receives requests for microbiological cultures isolated from samples analyzed by FDA. Requests for other entities isolated, extracted, or produced by sample analysis, i.e., chemical isolates, extracts, filth debris, etc., may also be received, especially regarding consumer complaint samples.

The Federal Food, Drug, and Cosmetic Act, makes no provision for FDA to provide to requesters portions of end or intermediate products resulting from FDA sample analysis. Section 702(b) of the act provides that, upon request, a part of an official sample of a food, drug, or cosmetic will be provided for examination or analysis to any person named on the label, the owner of the sampled product, or his attorney or agent. This section of the act applies to portions of the sampled commodity. It does not apply to intermediate or end products resulting from sample analysis.

POLICY:

Portions of intermediate or end products resulting from FDA sample analyses will not be routinely provided to requesters from outside the agency, including consumers from whom samples have been collected as part of the complaint investigation.

Exceptions to this policy may be considered when the agency determines that providing portions of intermediate or end products to the requester would help resolve a serious public health matter or would benefit the public wellbeing. When a request appears to warrant such consideration, the request should be referred to the Office of Compliance within the appropriate center for review.

Issued: 3/23/88

Sec. 150.500 Analytical Methodology Used by FDA - Drugs (CPG 7152.01)

BACKGROUND:

There have been continuing problems concerning the appropriate analytical methodology used by FDA laboratories in support of regulatory actions. In several cases regulatory actions have been disapproved and much analyst time wasted because the analyst did not adhere to the appropriate analytical method. Where regulatory actions are predicated upon analytical findings the appropriate methods are generally those stated in the USP/NF, an NDA, or a firm's Standard Operating Procedure, as applicable.

POLICY:

Where FDA sample analysis is a basis for regulatory action only the following procedures are considered appropriate, unless specific instructions to the contrary are given by Center for *Drug Evaluation and Research.*

1. For official drugs (USP/NF) the official compendial analytical methods are to be used, unless the FDA has promulgated regulations under Section 501(b) (or, for antibiotics, Section 507) of the Act prescribing appropriate tests or assay methods, in which case the regulations are to be followed.

2. A non-official drug which is the subject of a new drug application is to be analyzed by the method in the NDA or ANDA.

3. A non-official drug which is not a new drug is to be analyzed by the method used by the manufacturer as part of its standard operating procedures. If the FDA analyst has concern over the validity of the unofficial method, those concerns should be documented.

4. When analyzing a product by any of the above methods, the method must be strictly followed.

5. When a drug is not covered by the above situations, the analyst may select an appropriate method with which to analyze the product. In selecting the method first consideration should be given to any existing AOAC method because AOAC methods have withstood the rigors of collaborative study. Any method selected must have been properly validated. If not previously validated it must be validated when it is used. Validation data must be submitted with worksheets when regulatory action is recommended.

6. When the compendial, NDA, or firm's method is not satisfactory (e.g., due to an interfering substance, non-reproducible method, (etc.)), then this should be reported to the Division of Manufacturing and Product Quality (HFD-320) for further followup and guidance.

For surveillance samples such as those collected during a multiple drug survey, the laboratory may substitute a validated non-official method for the original analysis. However, any out-of-limit results must be confirmed by check analysis using the official or other appropriate method.

*Material between asterisks is new or revised*

Issued: 7/1/81
Revised: 9/1/86, 3/95

Sub Chapter 160 Regulatory

Sec. 160.100 Regulatory Actions and Small Business (CPG 7153.12)

BACKGROUND:

On September 19, 1980, President Carter signed the Regulatory Flexibility Act, S. 229. This Act delineates procedures for regulatory and informational requirements to ensure that the special needs of small business are considered. Some of the Act's goals are:

To improve the relationship between Government and small business.

To ensure that Federal regulations do not impose unnecessary or undue burdens on small business.

Historically, FDA has always responded to inquiries relating to the enforcement of the laws and regulations it has responsibility to enforce. However, with one exception, it has not sought out those - such as members of the small business community - who might have a greater need for assistance. The exception is the Office of Small Manufacturers Assistance which was established in the *Center for Devices and Radiological Health* in compliance with Section 10 of the Medical Device Amendments of 1976. This office has an aggressive outreach program for the specific purpose of finding small manufacturers (of medical devices) and helping them comply with FDA regulations. FDA has initiated an agency-wide small business assistance program in accordance with presidential directives issued on June 14, 1978 and November 16, 1979.

The objectives of this program are to:

- Take all feasible steps to minimize the economic impact of regulation.

- Encourage small businesses to participate in the Agency's decision making processes.

- Provide small business with easier access to all levels of the Agency.

- Provide regulatory options which are least costly to small business.

- Help small business to understand and comply with FDA's regulations.

A number of efforts in this program are being implemented through Small Business Representatives (SBR's) working out of the New York, Atlanta, Chicago, and San Francisco regional offices. Firms located outside of the geographical areas of the four SBR's may continue to contact the nearest FDA district office for information and assistance. They may also direct inquiries to:

*Industry Liaison Staff, Office of External Affairs HF-50
5600 Fishers Lane
Rockville, Maryland 20857
(301) 443-*6776*

Medical device manufacturers should address their requests to:

Division of Small Manufacturers Assistance (DSMA) HFZ-220
*1350 Piccard Drive*
Rockville, MD 20850
(301) 443-6597*

The Small Business Representatives, the Field Small Business Coordinator, and the FDA district offices are providing the following services:

- Giving technical assistance.

- Clarifying FDA rules and regulations.

- Providing information on proposed regulations and other issues and encouraging small businesses to provide comments and petitions to the Agency.

- Providing information on Agency hearing procedures and how small businesses can participate in hearings.

- Interpreting the laws and regulations as they apply to specific circumstances.

- Suggesting methods of meeting Agency requirements.

- Explaining registration, reporting requirements, and providing the forms.

- Conducting workshops and seminars specifically directed to the problems of small businesses.

At the request of a firm, the SBR may make onsite visits. During these onsite visits, the SBR will review and analyze problems that concern the firm, as well as any problems encountered during the visit. The SBR (or DSMA representative) will explain how the law and regulations apply to these concerns and possible courses of action available to the firm and to the agency.

POLICY:

Onsite Visits

The SBR must submit to the appropriate Regional Food and Drug Director a general summary of each visit. (This summary is available to the public under the Freedom of Information Act.) This informal report will briefly describe the reason for the visit, list the topics discussed, and in the event that the SBR observes violations, describe their characteristics. Although these visits are nonregulatory in nature, they may in some instances result in later compliance inspections.

FDA will continue to assist firms attempting to bring themselves into compliance. Such cooperation provides added assurance that the public will receive safe and wholesome products. Special consideration for the needs of small businesses does not include concessions from compliance with the laws and regulations. All firms, regardless of size, must comply with the laws for which FDA has responsibility.

If a *Warning* letter has issued, or other regulatory action has commenced against a firm or its product, the firm in question will not be serviced by FDA's small business assistance program. Until such regulatory action is terminated, any information or assistance desired by the firm will be handled by other Food and Drug personnel.

*Material between asterisks is new or revised*

Issued: 4/1/81
Revised: 8/31/89, 3/95

Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity (CPG 7153.09)

BACKGROUND:

The Food and Drug Administration has used income tax information from the Internal Revenue Service in the past to aid the agency's investigative efforts.

POLICY:

The policy of the agency is that such usage will not be routine. The need for such information will, under all circumstances, be referred to the Associate Commissioner for Regulatory Affairs for a final determination.

If income tax information or actual tax returns are received from the IRS, all such information will be treated as confidential. The physical location of all such information as well as persons who have access to it will be reported to the Associate Commissioner for Regulatory Affairs who will approve these arrangements.

*Any request for information FDA obtained from IRS should be referred to IRS for response. Privacy Act considerations are covered under 21 CFR 21.1 and 21.10.*

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 2/23/88, 4/21/88

Sec. 160.300 Requests for Records Under Section 703 (CPG 7153.02)

BACKGROUND:

*Questions have existed among the field districts regarding the existence and extent of their authority to deal with demands for written requests under Section 703. A memorandum on 3/27/67 from the then Bureau of Regulatory Compliance to District Directors delegated to the districts full authority to issue letters upon demand under Section 703. This authority is still in effect.

Evidence obtained in response to a specific written request under Section 703 cannot be used in a criminal prosecution of the person from whom obtained. Your attention is invited to the definition of the term "person" contained in Section 201(e). This means that a contemplated defendant from whom evidence is so obtained will not be prosecuted with respect to any particular count in which evidence so obtained is directly or indirectly involved. This does not, however, mean that evidence obtained under this section cannot be used to support seizure action or a complaint for injunction.*

POLICY:

A *Section* 703 letter may be issued by the field or district office anytime a decision is made that the importance of the evidence to be obtained outweighs the disability of precluding prosecution of the person from whom the evidence is being obtained, on the particular facts about which the evidence is being sought. This assumes that the necessary evidence cannot be legally obtained from other sources.

*Material between asterisks is new or revised*

Issued: 12/3/73
Revised: 10/1/80, 8/31/89

Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation (CPG 7153.03)

BACKGROUND:

Section 305 of the Act states: "Before any violation of this Act is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding."

A similar provision was incorporated in the 1906 Act. This subject is also covered by regulation under 21 CFR 7.84, 7.85, and 7.87.

*Section 305 procedures have been used as a warning in order to induce corrective action. Such use solely for purposes of warning in order to induce correction is contrary to the purpose of Section 305, and should not be used in lieu of other procedures to achieve corrective action.*

POLICY:

*Section 305* should be used only when initiation of prosecution is actually being considered by the agency.

*Material between asterisks is new or revised*

Issued: 12/3/73
Revised: 10/1/80, 8/31/89

Sec. 160.500 Answering Inquiries on Status of Criminal Referrals (CPG 7153.05)

BACKGROUND:

Potential criminal cases are frequently preceded by an opportunity for proposed defendants to present their views on whether a criminal action should be forwarded to the United States Attorney. It is not unusual for prospective defendants, their attorney, and/or their representative to contact district headquarters offices subsequent to the Section 305 meeting to inquire about the agency decision and status of the case. The following policy applies to such inquiries from such persons.

POLICY:

1. The inquirer may be advised, if it is true, that a decision was reached not to forward a case for prosecution.

2. If the inquirer is confirmed to be the subject of the potential referral (or a representative of a subject) and the proposed case has not as yet been forwarded to the Department of Justice, advise the inquirer the case is still under consideration. Avoid identifying the unit handling the case at that time (i.e. district, center, *Chief Counsel,* or Commissioner's office).

3. If the subject of the potential referral wishes to submit additional facts, be guided by 21 CFR 7.85 (g). If the inquirer wishes a meeting to present such facts, the Agency may want to meet with the individual if it will not unduly delay processing of the matter. Inform the inquirer that we will give appropriate consideration to what other facts are presented that have a direct bearing on the case. Any such meeting with a person previously accorded an opportunity to present views under Section 305 will be considered an extension of that opportunity.

4. Once a case has been referred to the Department of Justice the matter is no longer in the hands of the Agency. It is then the prerogative of the Department of Justice to determine what contacts to have with the proposed defendant. Do not reveal to an inquirer that any matter has been referred to the Department of Justice unless FDA's Office of Chief Counsel has confirmed that the referral may be revealed. Inform the inquirer that the case is still under consideration and notify the *Office of General Counsel* of the communications.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 4/10/9, 8/96

Sec. 160.600 Payment of Expert Witnesses (CPG 7153.07)

BACKGROUND:

FDA Staff Manual Guide 2610.2 sets *limits for expert witness court appearance fees* in a Food and Drug case. The Department of Justice has no strict set limits and usually can pay considerably more than FDA in order to obtain expert witnesses.

Traditionally, FDA has paid expert fees in all of our cases. However, because of our fee limit, it has been difficult in some cases to obtain appropriate expert testimony. On occasion, in such cases, the local U.S. Attorney has paid all or part of those expert witness fees, particularly when that office has been particularly active in the case.

Department of Justice policy in payment of experts in Food and Drug cases has not always been clear or consistent and frequently depends on which part of the Department is involved, i.e., U.S. Attorney or Office of Consumer Litigation.

POLICY:

Accordingly, the agency should, in the first instance, assume that it will bear the cost of expert testimony to the limits of the FDA expert witness schedule. However, in the light of past history, whenever it seems appropriate or necessary to have a greater supply of funds for this purpose, the agency should inquire of the appropriate Department of Justice representative whether they will participate in the payment of such fees for the experts needed in our cases.

*Material between asterisks is new or revised*

Issued: 10/26/76
Revised: 11/29/77, 10/1/80, 12/3/86, 10/16/87

Sec. 160.700 Reconditioning of Foods Adulterated Under 402(a)(4) (CPG 7153.04)

BACKGROUND:

Questions have arisen concerning what is adequate reconditioning of food products found to be prepared, packed or held under conditions which cause them to be adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

The following policy applies to foods which are proposed to be reconditioned after having been seized because of being prepared, packed, or held under Section 402(a)(4) conditions. It also applies to the situation where a lot of food is being voluntarily reconditioned after having been prepared, packed, or held under Section 402(a)(4) conditions.

POLICY:

*FDA will accept reconditioning proposals for foods adulterated due to Section 402(a)(4) conditions when such proposals include provisions for determining:

1. whether the food has become physically contaminated,

2. the extent and type of any contamination, and

3. procedures that will result in eliminating such contamination.

In addition, the proposal must provide for removing the Section 402(a)(4) conditions which cause the product to be adulterated. These conditions pertain not only to the product itself, but also to the environment found within the facility in which the product was prepared, packed or held. This is particularly important because a Section 402(a)(4) charge is actually an environmental charge. Correction could be achieved, for example, by brushing or vacuum cleaning filth from the outside of a bag, stripping stained outer layers from a multi-ply bag, or rebagging the product. Such actions, however, are product specific and do not address the corresponding corrections necessary to remove the (a)(4) conditions in the facility. Examples of facility related corrections could include: contracting with an exterminator, performing structural modifications to the actual building to preclude rodent entry, setting up a plan to assure appropriate stock rotation or other actions that would result in the elimination of the rodent or insect infestation. If the facility deficiencies are not corrected, moving the food to a sanitary facility may be necessary before reconditioning can begin.

Sampling and testing may also be required during and after completion of the reconditioning process.*

*Material between asterisks is new or revised*

Issued: 4/7/76
Revised: 10/1/80, 7/21/89

Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning (CPG 7153.14)

BACKGROUND:

The question has arisen as to whether drug and device products that have been produced or held by methods or under conditions not in accordance with Good Manufacturing Practice regulations, and consequently determined to be adulterated, may be reconditioned and returned to trade channels. Situations covered by this CPG are those in which a "formal" judgment of adulteration has been rendered; e.g., drug and device products that have been seized and condemned pursuant to Section 304 of the Act due to Good Manufacturing Practice deficiencies, drug and device products that have been recalled because they were found to be in violation of the CGMPRs, etc. Although GMP deficiencies can be corrected in subsequent batches or lots of the involved product(s), it may be difficult or impossible to correct the effect of the deficiencies retrospectively in batches or lots already produced.

POLICY:

The reconditioning of drug and device products found to be adulterated as a result of having been produced, processed, or held under conditions which are deficient with regard to Good Manufacturing Practice regulations may be approved providing all of the following conditions are met as follows:

1. Any reconditioning proposal must be reviewed by all parties concerned (District, Center, OE, *OCC*) to determine whether the plan can reasonably be expected to bring the drug device product(s) into compliance.

2. In order to be acceptable, a proposed reconditioning plan must overcome any observed GMP deficiencies and correct any known product defects present.

3. If the lot to be reconditioned is held within the facility where the GMP violations occurred, the violative conditions must be corrected in advance of accepting a reconditioning proposal, or included as part of the reconditioning proposal.

4. If the lot is held in a facility separate from the one in which the GMP violations occurred and the separate facility is in compliance, a reconditioning proposal can be considered as provided for in paragraphs 1 and 2 above.

No product shall be released until all reconditioning commitments are fully met as verified by FDA.

*Material between asterisks is new or revised*

Issued: 3/1/83
Revised: 3/95, 8/96

Sub Chapter 170 Specific Problems - Non-Food, Drug, or Cosmetic Related

Sec. 170.100 Turtles - Ban on Interstate and Intrastate Sales and Distribution (CPG 7129.01)

BACKGROUND:

Turtles may carry Salmonella genus (including Salmonella arizona strains) bacteria and may transmit these bacteria to humans, causing salmonellosis. Salmonellosis is characterized by severe gastrointestinal symptoms (abdominal pain, nausea, fever, and diarrhea) and occasionally results in death.

POLICY:

The sale or commercial distribution of viable turtle eggs and small turtles (carapace length less than 4 inches) for use as pets is banned under 21 CFR 1240.62. The ban is based on the Public Health Service Act (section 361, 58 Stat. 703) and therefore applies to both intrastate and interstate sale and distribution. Exceptions to the ban under 21 CFR 1240.62 permit sales of turtles and turtle eggs for use in bona fide scientific, educational, or exhibitional purposes other than as pets and of marine (ocean) turtles. Other exceptions to the ban are the sale of turtles and turtle eggs not in connection with a business (e.g., limited sales between turtle fanciers have been permitted) or that are intended only for export. The ban applies to small turtles (under 4 inch carapace length) because these are most likely to be held for sale as children's pets, and the purpose of the ban is to protect children from turtle-born salmonellosis.

FDA will respond to consumer and state and local government complaints. If illegal turtles are encountered during the course of regular FDA activities appropriate action should be taken. If illegal pet turtles are found in distribution channels, the following are recommended:

1. Determine whether the State or local government has regulations controlling turtles. If so, they should be encouraged to assume primary responsibility and report the source or subsequent distribution of the turtles outside their jurisdiction to FDA for appropriate followup. If a State or local government is unable or unwilling to take appropriate action, FDA will assume primary responsibility for the investigation.

2. Advise the person or persons who are offering for sale, or other commercial distribution, turtles with a carapace length of less than four (4) inches in length or viable turtle eggs, that they are in violation of 21 CFR 1240.62. Provide a copy of the regulations to the person in charge.

3. Determine, if possible, the source and subsequent distribution of illegal turtles. Send surveillance reports to the home districts of the turtle suppliers and distributors and report sub-distribution so that followup may be made to effect removal of turtles from distribution. Also, report purported "legal" distribution under the exceptions listed in 21 CFR 1240.62 (e.g., shipments to pet stores invoiced as "for scientific purposes") so that investigations can be made of diversions to pet sales.

4. Encourage appropriate voluntary disposition whenever possible (see paragraph 6).

5. If voluntary disposition cannot be obtained, issue a Demand for Disposition letter. If sale or distribution of turtles or turtle eggs in violation of 21 CFR 1240.62 has already been documented by a State or local government agency, the Demand for Disposition letter may be issued on that basis. (For a guide for preparation of the Demand for Disposition letter see Attachment A.) After service of the Demand for Disposition, take all reasonable precautions to insure that the person in possession of the turtles or turtle eggs will not sell, distribute, or otherwise dispose of any of the turtles or turtle eggs except in a manner that precludes children obtaining the turtles.

6. Any reasonable voluntary or on-demand method of disposition that accomplishes the goal of removing small turtles from general sale, or distribution is acceptable (e.g., donation to a zoo). The Humane Society may be willing to supervise release to the wild in an appropriate habitat. Destruction of the turtles by FDA personnel at the district office using a humane method is indicated if an acceptable alternative method of disposition is not available. Because turtles are "cold blooded," freezing is a humane method of destruction.

7. Following destruction, the turtles should be disposed of in a manner to preclude spread of any contaminating organism.

8. Forward a copy of the investigation (including the source, any subsequent distribution and disposition) to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*.

REGULATORY ACTION GUIDANCE:

If a dealer refuses to comply after receiving the Demand for Disposition letter (Attachment A), and evidence is obtained that turtles continue to be held for sale or distribution in violation of 21 CFR 1240.62, *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* should be contacted before submission of a regulatory action proposal.

GUIDE LETTER FOR DEMAND FOR DISPOSITION

On June 1, 1983, FDA investigator Jones inspected (insert name of organization, company, person, or persons).

The inspection showed that turtles were being offered for sale or public commercial distribution (recite with particularity the facts which justify the demand).

Pursuant to the Code of Federal Regulations, Title 21, section 1240.62, a copy of which is attached, demand is made that these turtles shall not be sold, distributed or otherwise disposed of except by an approved method of disposition (e.g., destruction by a humane method such as by freezing, release to the wild, or donation to a zoo) by or under the Supervision of the ____________ District of the Food and Drug Administration.

You may comply with this demand for disposition or within 10 working days appeal the demand to the Director of the *Center for Food Safety and Applied Nutrition*, Food and Drug Administration, 200 C Street, S.W., Washington, DC 20204. Such manner of appeal is described in section 1240.62(c) of the attached regulation (21 CFR 1240.62). Please contact _________________ at (telephone No.) to arrange for supervision of the disposition of the turtles.

/s/

District Director

*Material between asterisks is new or revised*

Issued: 5/1/84
Revised: 8/31/89, 3/95

Model Certificate for Export

The U.S. Food and Drug Administration certifies for [COUNTRY] the following information concerning the product listed below manufactured or distributed by [NAME OF COMPANY], [ADDRESS]:

NAME OF PRODUCT (GENERIC NAME IF APPLICABLE)

CENTRAL FILE NUMBER (CFN) (IF UNIQUE IDENTIFIER IS REQUIRED)

PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA NUMBER, 510(k) Number)

The product (and the plant which produces it) described above are subject to the jurisdiction of the Food and Drug Administration.

It is certified that the above listed product may be freely marketed in, or may otherwise be exported, from the United States of America at this time.

The manufacturing plant in which the products are produced is subject to periodic inspections, and the last such inspection showed that the plant, at that time, appeared to be in compliance with current Good Manufacturing Practice (GMP) required by the Federal Food, Drug, and Cosmetic Act.

Signature

Title

Food an Drug Administration

________________________________________________________________________ __ ___________________

Country of _________________

State of _________________

Subscribed and sworn to before me this _________________ day of _________________.

APPENDIX 2 - EC EXPORT HEALTH CERTIFICATE

CERTIFICATE NO. _________________

HEALTH CERTIFICATE

Covering fishery products for import into the European Community.

Country of dispatch: __________________________________

Competent authority (1): __________________________________

Inspection body (1): ____________________________________________________

Reference number of health certificate: __________________________________

1. Details identifying the fishery products

Description

- Species (scientific name) __________________________________

- State (2) or type of processing __________________________________

Type of packaging: __________________________________

Number of packaging: __________________________________

Net Weight: __________________________________

Temperature required during storage and transport:_____________________________

2. Provenance of the fishery products

Address(es) and number(s) of preparation or processing establishment(s) authorized for exports by the competent authority: _______________________________________________________________________

3. Destination of the fishery products

The fishery products are to be dispatched from :__________________________________________________

(Place of dispatch)

to:______________________________________________________________________ __ __________

(Country and place of destination)

by the following means of transport:__________________________________________________________

Name and address of consignor:_______________________________________________________________

Name of consignee and address at place of destination: __________________________________________

Signature:__________________________________ Date:__________________________________

4. Health Attestation

The undersigned official inspector hereby certifies that:

1. The fishery products above have been handled, prepared or processed, identified, stored and transported under conditions at least equivalent to those laid down in Council Directives 91/493/EC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products.

2. In addition, in the case of frozen or processed bivalve mollusks, the latter have been gathered in production areas subject to conditions at least equivalent to those laid down in Council Directive 91/492/EC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve mollusks.

Done at __________________________________ on __________________________________

(Place) (Date)

__________________________________

Signature of Official Inspector

__________________________________

Name in capitals, capacity and qualifications