Marketing OTC Drugs in Convenience Size or Sample Packages

If you’re a new company, or an existing one with a new OTC drug product, you may be considering giving away free samples to entice customers into a future purchase. Or perhaps you just want to sell your product in a small convenience-size pack so it can be displayed in a grocery store or gas station check-out location.  Marketing small packs such as these presents difficulties in terms of accommodating all of the label information required to meet FDA compliance.

When the FDA published the final rule establishing the standardized format and content (“Drug Facts”) regulations in 1999, it made no exceptions for these small packs.  Indeed, in the Comments section of the Federal Register notice, the agency specifically stated that it considered the Drug Facts information essential for safe use of the product, irrespective of the size or shape of the package, and advised manufacturers to reconfigure their packaging to meet the requirements of the regulation. 

Fast forward to 2002, at about the time that the Drug Facts requirements were to become effective, the FDA issued a partial delay of compliance for “convenience-size” OTC drug products in response to a citizen petition that had been submitted to the agency.  The FDA agreed that some accommodation may be appropriate for these products based on their limited use.  At that time, the FDA defined convenience-size package as one that (1) contains no more than two doses of the drug product and (2) because of its limited available labeling space, would require more than 60 percent of its total surface area available to bear labeling to meet the labeling requirements of 21 CFR 201.66 and therefore qualify for the modified labeling format.  To clarify further, the agency defined dose as the maximum single-serving for an adult (or child for products marketed only for children) as specified in the product's directions for use. For products marketed with directions for both adults and children, dose would mean a maximum single serving for a child as specified in those same directions.  

As a result of this stay, manufacturers selling convenience packs were allowed to continue to market their product in a labeling format different from that specified in the regulation, although the labeling would still have to comply with all other regulatory requirements (e.g., statement of identity, declaration of quantity, name and place of business, etc.)

The issue was next addressed by the FDA in the form of a proposed rule published in the Federal Register in December 2006, in which the agency retained the definitions noted above and outlined alternative labeling requirements that would allow for certain information to be omitted from the outer package, provided it was available inside the package (and the consumer directed to “See information inside before using.”)  It was noted at the time that “the proposed definition of ‘dose’ would also apply to sample and trial-sized packages that contain only one or two dosage units of an OTC drug.” 

As with any proposed rule, the FDA invited specific comments from industry and other interested parties, but to date no final rule has been published.  In the meantime, for those companies wishing to market convenience- or trial-size packages, these proposed rules provide guidance as to how the products should be labeled to meet the requirements of the Drug Facts regulation and provide consumers with the information that they need for safe use of the drugs. 

FDA Updates Establishment Registration & Drug Listing Regulations

With the new year in swing, it’s worth reminding companies of their obligation with regard to Establishment Registrations and Drug Listings.  As such, they should be aware that the FDA published a final rule amending these regulations in August of last year.   These revisions update and clarify existing regulations and implement most of those that were proposed in 2006, and which were subsequently mandated by legislative changes to the FD&C Act, particularly those requiring electronic submissions.   The effective date for updated regulations was November 29, 2016 so companies should review the regulation to make sure that they are following the new requirements.

 For OTC products, it’s worth noting that the responsibilities of private label distributors (common in the industry) and the manufacturers that supply them have been more clearly defined. 

Some of the key changes/clarifications are as follows:


  • Establishment registration number and Unique Facility Identifier (UFI) are two different numbers. The former is assigned by the FDA (upon a separate request) after an establishment is registered for the first time and is also referred to as the Facility Establishment Identifier (FEI).  The UFI is the DUNS number that is included with the initial registration.  
  • Content of labeling was added to describe what information needs to be included in that section of the drug listing submission.
  • Private label distribution, Relabeler and Repacker were added to the definitions as all of these functions have responsibilities that were previously unclear with regard to the registration and listing requirements.
  • Salvage/Salvager were added and define activities surrounding segregation of products that may have been subject to adverse storage or handling conditions but for which a firm wishes to return them to the market.

Establishment Registration

  • Establishment registration is required for all foreign and domestic manufacturers, repackers, relabelers and salvagers (unless otherwise exempt as provided for in the regulation).  
  • Private label distributors should not register any establishment (unless they also perform one of the functions above or are acting as an authorized agent on behalf of another establishment).  They must, however, apply for their own labeler code.  

Drug Listing

  • Registrants are responsible for listing each drug in commercial distribution, including those drug products that are marketed through a private label distributor (although private label distributors may elect to do their own listings if acting as an authorized agent on behalf of a registrant.)
  • Registrants must review their drug listing information each June and December and either update it accordingly or certify that no changes have occurred.  The regulation is not clear how this “no changes” certification is accomplished however, the FDA subsequently published on their website that this would be done simply by submitting an update to the Labeler Code file. It’s worth noting therefore that Private Label Distributors, as “owners” of those files, would need to submit their own “no changes” certification.
  • Drug listing submissions must now include a complete listing of inactive ingredients and their corresponding Unique Ingredient Identifier (UNII) - this was previously optional.  


  • Changes that trigger a revision to the product code portion (i.e., middle segment) of the NDC were clarified.  Although the proposed rule had included a provision such that changes to inactive ingredients would necessitate a new product code, this was not adopted in the final rule.
  • The FDA clarified the restrictions for using NDC numbers on non-drug products (e.g., dietary supplements, medical foods).   Such representations render the product misbranded.  

There were 2 major changes proposed in 2006 that were NOT incorporated into the final rule:

  1. FDA did not assume responsibility for assigning the NDC to a product, but will continue to accept the product and packaging segments of the NDC that are proposed by the manufacturer in the drug listing submission. 
  2. OTC product labeling will not be required to declare the NDC numbers, although FDA will continue to request their inclusion.  

There is quite a bit more information in the regulations, particularly in the Comment section of the Federal Register notice. It’s worth reviewing that, as well as the regulations themselves, to gain an understanding of the new requirements. 

NDCs - Concept, Construction and Compliance

All drug products, whether prescription, over-the-counter, homeopathic or even combination cosmetic-drug products are required to have a National Drug Code number, otherwise known as an NDC.  This number is a unique 10-digit, 3-segment number that identifies the labeler (which could be the manufacturer or the distributor), the product, and the package size. 

The concept of an NDC, what it is and how it’s configured seems to be confusing to many companies who are under the impression that it must be obtained from the FDA. But the process is actually much easier than that once it is understood how the number is constructed.

The FDA assigns only the first part of the NDC, known as the labeler code.  This is a 5-digit number assigned to a firm upon application of a Labeler Code Request which is done through the agency’s electronic submission portal.  A “labeler” is a firm that manufactures, repackages, relabels, or distributes (under its own name) the drug. As such, private label distributors are required to have their own labeler code.  

The NDC is not required to appear on product labeling, but if a firm wishes to include it, the FDA has set forth specific criteria regarding its placement, prominence and display.  These requirements are outlined further in 21 CFR 207.35 (b)(3). 

Once it has its labeler code, the firm itself assigns the last remaining numeric characters of the NDC (the Product Code and Package Code).  As worded in 21 CFR 207.35 (b)(2)(ii):

“The manufacturer or distributor will assign the Product Code and the Package Code before drug listing and include these codes in Drug Product Listing. The manufacturer or distributor may use either of two methods in assigning the Product and Package Codes: a 3-2 Product-Package Code configuration (e.g., 542-12) or a 4-1 Product-Package Code configuration (e.g., 5421-2). A manufacturer or distributor with a given Labeler Code shall use only one such Product-Package Code configuration and shall use this same configuration in assigning the Product-Package Codes for all drugs included in the drug listing.”

While there are products with 4-4-2 NDC configurations, these are associated with companies that were in existence when 4-digit labeler codes were being assigned. The FDA currently assigns 5-digit codes only.

Once the labeler code is obtained, the company assigns the product code and package code as follows:  

The Product Code identifies the product - its strength, dosage form, and formulation. There is no set procedure or pattern but it will be unique to each firm based on their choosing. Different formulations, or different strengths of the same formulation, should have different product codes.  Likewise, products that share the same formulation but have different characteristics (e.g. shape, color) should also have different codes.  

The Package Code identifies the trade package size and type.  Different package codes differentiate between the quantitative and qualitative attributes of the product packaging, like the number of pills a bottle, or the weight or volume of a product, or the type of package like bottle, blister pack or tube.

Whether to use a 3-2 configuration or 4-1 configuration will be dependent on the number and type of products / packaging configurations of a given firm.  Consideration should be given to future growth and expansion so that a maximum number of numeric combinations are possible. In any case, it’s strongly recommended that a firm defines its numbering system in a procedure so that it is consist across the product range.  This also helps to avoid errors and duplication.

The NDC is “registered” with the FDA at the time of drug listing, i.e., when the product enters commercial distribution and subsequently gets published in the agency’s NDC Directory, a searchable database on their website. It the product is discontinued, that NDC cannot be assigned to another product for 5 years after the last expiration date of that product. Note that Drug Listing does not confer any type of FDA approval; but rather serves as a mechanism for the agency to monitor currently marketed drug products.  

New Initiatives on OTC Internal Analgesics

Despite widespread use of products such as aspirin, acetaminophen, and ibuprofen in the general population, the tentative final monograph for OTC Internal Analgesic, Antipyretic and Antirheumatic Drug Products, issued in 1988, still has not been finalized.   The FDA has instead addressed specific concerns through separate rulemaking procedures, such as mandating the addition of an alcohol warning to the labels in 1998 followed by organ-specific warnings in 2009.

Since that time, to better educate consumers and encourage safer use of these products, the FDA has also issued several guidance documents for industry recommending further changes to the labeling, packaging and even formulation, particularly for acetaminophen-containing products.  These include a draft guidance published in 2012 allowing for alternative wording in the liver warning and, late last year, a draft guidance recommending the addition of an allergy alert that would warn users of the potential for severe skin reactions.

Just recently, the agency finalized another guidance document pertaining to OTC pediatric oral liquid acetaminophen-containing products in which it recommends that manufacturers market just a single concentration of 160 mg of acetaminophen per 5 mL dose, that the products are packaged with a dosage delivery device (preferably with a flow restrictor) and that the wording on the labeling is updated to reflect these changes.  While this, as with other FDA guidance documents, is not legally enforceable, most companies had already voluntarily implemented these recommendations following an initiative started in 2011 by the Consumer Healthcare Products Association member companies.

It should be noted however, that the FDA’s concerns are not limited to acetaminophen.  Based on a Drug Safety Communication released in July, the agency will be requesting additional changes to the Drug Facts of OTC non-aspirin NSAIDs (e.g. ibuprofen, naproxen) to strengthen the existing warnings of increased risk of heart attack and stroke.   These new warnings will recommend that those taking NSAIDs seek medical attention if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.   

As with all FDA initiatives, it is recommended that firms monitor the agency website as well as Federal Register Notices to stay abreast of current developments. 

FDA Seeks Input on Regulation of Homeopathic Medicines

Last week’s announcement by the Food and Drug Administration (FDA) that it is seeking input on its oversight of homeopathic products appeared to be big news, both within the industry and across the broader news spectrum, no doubt because the homeopathic drug industry has grown significantly in recent decades.

Homeopathy is a form of alternative medicine based on the concept that a disease can be treated with minute quantities of natural substances that would, if given in larger amounts to a healthy person, produce symptoms of disease.  The practice of homeopathy has been around for more than 200 years and has its share of both critics and adherents.

The term “drugs”, as defined in the Federal Food, Drug and Cosmetic Act, encompasses articles recognized as such in both the United States Pharmacopoeia (USP) as well as the Homeopathic Pharmacopoeia of the United States (HPUS).  This latter reference has been in continuous publication since 1897 and determines which ingredients, including allowable potency levels, are officially monographed homeopathic ingredients.

FDA’s over-the-counter (OTC) drug review was established in 1972 to evaluate the safety and efficacy of OTC drug products but, at that time, the agency deferred action on homeopathic medicines.  Current regulation of homeopathic drugs falls under the auspices of a Compliance Policy Guide (“Conditions under Which Homeopathic Drugs May be Marketed”) issued in 1988.  All homeopathic medicines must be manufactured in compliance to FDA’s Good Manufacturing Practices regulation, must meet FDA’s strict labeling requirements and manufacturers must report serious adverse events to the FDA.

Nevertheless, these homeopathic products have not been evaluated by the FDA for safety and efficacy.  As such, the agency is asking for input from interested parties (manufacturers, health care professionals, consumers, etc.) as to whether the framework for regulating such products needs to be addressed.  Some of questions to be considered include:

  • current enforcement policies and/or whether there may be suitable alternatives
  • consumer and healthcare provider attitudes towards these products and whether there is sufficient information available to each in order to make informed decisions regarding their use
  • data sources that could be shared with the  FDA for the agency to better assess risk and benefit profiles of products labeled as homeopathic 

While no formal recommendations will be forthcoming at the meeting, scheduled for April 20-21, the information presented should foster much discussion as to how the current regulatory framework will change in the years ahead.

FDA Recommends New Label Warning on OTC Acetaminophen Products

On November 28, 2014, the FDA issued a draft guidance for industry recommending that an additional warning statement be included on the labeling of single- and combination-ingredient acetaminophen products informing users of the possibility of severe skin reactions. 

This new guidance is specifically directed to those companies marketing acetaminophen products under the Tentative Final Monograph for Internal Analgesic, Antipyretic and Antirheumatic Drug Products and follows an earlier Drug Safety Communication (DSC) issued by the FDA in August 2013.  At that time, following a review of its Adverse Event Reporting System database, as well as medical literature, the FDA determined that there was a potential for rare but serious skin reactions associated with the use of these products.  The DSC was issued to notify both healthcare professionals and patients of this risk and advised anyone who may have experienced a skin rash or similar reaction to stop taking the drug and seek medical attention.   The DSC also mandated the addition of a warning statement to labels of prescription drugs containing acetaminophen and requested the same for over-the-counter acetaminophen-containing products marketed under an approved application.  It appears that most of these manufacturers have incorporated the label changes.
For OTC acetaminophen products marked under the aforementioned tentative final monograph, the FDA is now encouraging these manufacturers to do likewise and has indicated that it will not object to the following language on the labeling: 

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening  blisters  rash
If a skin reaction occurs, stop use and seek medical help right away.

The new warning should be placed directly under the Liver Warning and should appear on all package configurations.  The guidance document does not address alternative wording that could potentially misbrand the product.

The FDA requests that comments on this draft guidance document be received by January 27, 2015 to ensure consideration in any final version. 

Made in the USA...but is it really?

In this global economy, where many goods can be manufactured more easily and cheaply in foreign countries, American shoppers like to express their economic patriotism and seek out products that claim to be “Made in the USA”.  This is especially true for medicines and dietary supplements that have the potential for harm if not produced in accordance with the FDA’s Good Manufacturing Practice regulations and other applicable safety standards that may not be as widely known or strictly enforced in foreign facilities.

In addition, manufacturers and distributors are eager to promote their products this way as a strategy to increase their market share and make them stand out from others that are unable to make this claim. 

But whether you are a consumer or a manufacturer, you should understand what the claim actually means.

The regulatory agency tasked with overseeing “Made in the USA” claims is the Federal Trade Commission (FTC) whose mission is, among others, to prevent deception and unfair practices in the marketplace.  For pharmaceutical and dietary supplement products to incorporate such a claim, they may only do so if “all, or virtually all” of the product is made in the USA.  

What is meant by “all, or virtually all”?  According to the FTC, this means that all significant parts and processing that go into a product must be of US origin. In other words, the product should contain no, or negligible, foreign content. In making this determination, the FTC considers several factors:

  • The final assembly or processing of the product must take place in the United States
  • The percentage of the product’s total manufacturing costs that can be assigned to US parts and processing
  • How far removed any foreign content is from the finished product (how far back in the manufacturing process was the foreign content used)

In other words, manufacturers need to consider the origin of the raw materials (ingredients) present in the product as well as the cost of labor involved in production, a very high standard to meet.  

In addition to an express claim of “Made in the USA”, manufacturers need to be cautious in their use of implied claims, such as a graphic of the American flag, on their labeling or in their advertising.  The FTC will examine such representations in the overall context in which they are used to determine if there has been a violation.

Should a manufacturer believe that its product actually does meet the requirements defined above, it should ensure that it has reliable and substantiated evidence to support the claim.  

FDA Issues Draft Guidance on OTC Pediatric Liquid Products Containing Acetaminophen

Acetaminophen is a widely used pain reliever / fever reducer found in both prescription and over-the-counter drug products, both as a single ingredient or in combination with other medicines.  Although generally safe when used at the recommended dosage levels, its presence in so many products has led to an increased incidence of unintentional overdoses in consumers that were either not aware of its presence in the various products being simultaneously ingested, or of its potential for serious adverse events when too much is taken. Such overdoses can have serious consequences, most notably liver damage and even death.

To address this concern, the FDA has issued several regulations and guidance documents over the past 15 years, from warnings on labels regarding use of acetaminophen in consumers with a history of heavy alcohol use to, more recently, limiting the strength of the drug in a given dosage unit.

As part of this on-going effort to encourage safe use of acetaminophen products, the FDA announced (Federal Register, October 8, 2014) the availability of another draft guidance on the subject entitled “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”.  In this document, the agency offers recommendations to industry to help minimize the risk to consumers of the liver damage associated with use of these products in children.  It is anticipated that these will eventually be codified into regulation following the formal notice and comment rulemaking process.

These recommendations include:

1.    Standardizing the concentration (to 160 mg per 5 mL) of acetaminophen in all single ingredient acetaminophen oral liquids marketed for pediatric use

2.    Changes to the labeling to enhance the display of this new concentration and more clearly indicate the age range and intended dosage for each 

3.    Revision of the packaging to include a dosage delivery device, preferably one with a flow restrictor, with clear markings that correlate to the dosing directions

It is noteworthy that some of these recommendations have already been adopted by much of the pharmaceutical industry voluntarily and this guidance should encourage others to follow.  

The FDA requests that any comments on this draft guidance document be received by December 8, 2014 to ensure consideration in any final version. 

Using Social Media to Promote your Consumer Healthcare Products

Facebook, LinkedIn, Twitter, Pinterest, Instagram – just a few of the common words today that were unheard of not that long ago.  Collectively they, and similar internet-based platforms, are known as social media and there are not many people that do not use at least one of these in their daily interactions with family and friends.  

Because of this widespread use, businesses have also recognized its potential as a marketing tool, allowing them to promote their products or services to a much larger audience than may have been previously accessible.  But, for those industries regulated by the Food and Drug Administration, there are additional implications in terms of maintaining compliance to applicable laws and regulations.

As such, the FDA issued 3 draft guidance documents this year pertaining to the use of social media for product advertising and promotion in an effort to help industry meet its regulatory obligations.  Although the scope of the documents is not applicable to OTC products, those companies that manufacture or distribute OTC drugs, dietary supplements or cosmetics should consider the general principles contained within, both in the development of their labeling as well as any subsequent marketing strategy using social media. In addition, as the advertising and promotion of these consumer products is governed by the Federal Trade Commission (FTC) companies must be aware of, and in compliance to, regulations promulgated by that agency.

When using social media for promotional activities, companies should take into account the following to ensure they are meeting both FDA and FTC requirements:

•    information should be presented in consumer-friendly language and consistent with FDA-required labeling for the product
•    information must be true; not false or deceptive in any way; any claims should be substantiated
•    information must present a fair balance between product effectiveness as well as any risk, and these should be published together in the same communication
•    if using a social media platform with character-space limitations, a mechanism (such as a hyperlink) should be provided to allow direct access to more complete information
•    any use of endorsements and testimonials should incorporate recommendations in the appropriate FTC Guides concerning such statements

While the points listed above are easily understandable for social media platforms controlled and operated by the company manufacturing or distributing a particular product, a challenge is presented when independent third parties get involved.   This User Generated Content (UGC) might appear on the interactive part of a company website or social media platform, or it may appear on a site that is independent of the company.  Sometimes this content is continuous and interactive such as seen on Facebook or it might just be a forum that allows information to be posted.  In such cases, companies should be careful how they react or respond to such posts as there have been instances whereby these have been considered endorsements of unapproved claims, resulting in issuance of an FDA warning letter.

Neither the FDA nor FTC are likely to hold companies responsible for third-party content and companies should be advised to avoid use of such statements in their own product advertising and promotions.   In addition, companies should have a written policy as to how they will address, if at all, situations in which UGC is incorrect or inaccurate, especially if there is a safety consideration or legal risk associated with a posting. 

Social media is here to stay and will likely expand in the years ahead. It is important to recognize that, while it will provide businesses with many opportunities for growth and expansion, this must be accompanied by a commitment to maintaining compliance to all relevant government regulations.

Gluten-Free Claims on Dietary Supplements and OTC Drugs

In the past decade there has been an increasing awareness of, and questions about, gluten.  What is this substance?  Why are so many people concerned about its presence in foods, medicines and dietary supplements?

Gluten is a protein found in cereal grains. While present in all grains, it is the gluten in wheat, barley, rye (and, to a lesser extent, oats) that triggers an autoimmune response in people with a condition called celiac disease.  Not a typical food allergy, celiac disease patients are unable to digest gluten, resulting in inflammation of the small intestine such that nutrients from the food cannot be properly absorbed.

Once the condition is diagnosed, the management of the disease sounds simple; just avoid ingesting any product that contains gluten.  But this is not so easy when it comes to drugs and dietary supplements in which the list of ingredients may be long and unfamiliar. Questions from consumers pertaining to gluten content are therefore very common to companies manufacturing these products.

While many products on the market are labeled as “gluten-free”, the actual requirements to make this claim had not been defined by the FDA until recently.  The final rule (implemented as part of the Food Allergen Labeling and Consumer Protection Act) was published last year and became effective August 5, 2014.  It is currently applicable only to foods and dietary supplements.  For drug products (prescription, non-prescription, biologic and homeopathic) the FDA is currently evaluating responses received to a December 2011 Federal Register notice requesting public comments.

The use of the term “gluten-free” on product labeling is strictly voluntary.  However, if a dietary supplement company is making this claim, it now means that the product does not contain any ingredient that is: 

1.    a gluten-containing grain
2.    derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 
3.    derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food

In addition, any unavoidable presence of gluten in products labeled as gluten-free, whether manufactured as such or that are inherently free of gluten, must be below 20 ppm.

The rule does not require companies to test their products for the presence of gluten but, if the gluten-free claim is made on any item, the company is responsible for ensuring that it contains less than 20 ppm of gluten.  This can be accomplished through:

•    testing the ingredients for gluten content using a scientifically valid method
•    requesting certificates of analysis from raw material suppliers, indicating gluten testing has been performed
•    participating in a third-party gluten-free certification program

Whichever method is chosen, appropriate records should be maintained, as always, in accordance with applicable regulation.  Also, companies should ensure that their responses to gluten content enquiries from consumers take into account the 20 ppm threshold.  While these responses would not fall under FDA’s definition of a label claim, this new requirement should be applied consistently in all product communications to avoid confusion.

For industry, this ruling provides a single definition and standard for ensuring product labeling is in compliance.  For consumers with celiac disease, or others who just want to avoid gluten in their diet, it provides confidence that such claims mean the same thing for all dietary supplements they may be using.

Dietary Supplements - Are More Regulations Needed?

Dietary supplements certainly seem to be in the news these days – and even more so when a well-known TV personality testifies before Congress.  Senator Claire McCaskill, chairwoman of the subcommittee on Consumer Protection, Product Safety and Insurance recently led a hearing that was convened to examine the false advertising claims made for weight loss products, some of which were promoted on “The Dr. Oz Show”.  Much has been written about the testimony and, as a result, the dietary supplement industry is coming under heavy criticism.

Is the industry too lax?  Is more regulation the answer?  Common assumptions among those reporting on the issue seem to be: 

1.    Dietary supplement manufacturers do not have to prove that their products work.
2.    Dietary supplements are allowed to make whatever claims they want.
3.    Dietary supplement manufacturers do not have to prove safety of their products.
4.    Dietary supplements are not regulated by the FDA.

Are these statements true?

The FDA defines a dietary supplement as a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet.” and includes, but is not limited to, vitamins, minerals, herbs, and amino acids. Such products are not intended to diagnose, cure, mitigate, treat or prevent a disease so they cannot be subjected to a standard of efficacy that would be expected of a drug product.

However, when a dietary supplement makes a claim, e.g., that it is going help a person lose weight, lower their cholesterol or improve their sexual stamina, then there is an assumption that it is going to have an actual pharmacological effect on one’s body.  There are three types of claims allowed by the FDA - health claims, nutrient content claims and structure function claims – none of which are the same as a drug claim and for which there are applicable regulations already in existence.  

With regard to safety, it is true that the manufacturer, not the FDA, is responsible for ensuring that the marketed product is safe. But again, it must be stressed that there are already rules and regulations that govern the dietary ingredients, the label content, good manufacturing practice, adverse event reporting, etc.  How would additional regulations make the product safer? 

So if dietary supplements are already regulated, what can be done to prevent bogus or tainted product from reaching the market?  

•    Increased enforcement of existing regulation through tighter vigilance of the market.  Although the FDA has limited resources, perhaps more of them could be allocated to monitoring of the internet and other media where it is not difficult to come across violative products. 
•    Strong penalties for companies (and their owners/operators) found in violation.  In a recent case in which a company was found to have been distributing adulterated product containing a prescription drug, the owner was fined only $60,000, an amount that is unlikely to deter others in a multi-billion dollar industry.
•    Better communication between the FDA and industry. While the current regulations do provide the framework, they are numerous and often difficult to interpret. Rather than more regulation, perhaps additional guidance documents could developed for industry to help determine what is acceptable in terms of dietary ingredients and making claims.  
•    Improved consumer education efforts.  Despite efforts by the healthcare industry and the FDA to educate consumers on the appropriate use of dietary supplements, there still appears to be far too many people looking for that “magic bullet”.  

In closing, it must be noted that there are many reputable, responsible dietary supplement manufacturers who make good products and follow the laws and regulations in existence.  They should not be penalized because others choose not to, nor should consumers be deprived of these products for which there is a strong demand.

Government Regulations in the OTC Drug and Dietary Supplement World - Does the Profusion Lead to Confusion?

Regulations, regulations, regulations…no matter what industry in which you are working, it is likely to be governed by some type of federal regulation.  Regardless of whether you believe them to be useful and necessary or just burdensome, compliance is expected and this is often difficult due to the very breadth and nature of what is required.  Ignorance of any of these regulations will not serve as an adequate excuse in the event of an inspection by a federal authority.

In the pharmaceutical/dietary supplement industry, regulatory professionals concentrate on those regulations promulgated by the Food and Drug Administration which cover nearly everything – good manufacturing practice, labeling, drug applications, recalls and much more. While certainly comprehensive, there are other government agencies whose rules and regulations are applicable to over-the-counter (OTC) drug and dietary supplement products.  These include:

Consumer Product Safety Commission – The CPSC is tasked with protecting the public from unreasonable risk of injury or death. As such, it administers the Poison Prevention Packaging Act that requires child-resistant packaging for hazardous household products. This includes most oral prescription drugs as well as specified OTCs and dietary supplements.  The agency also oversees the Consumer Product Safety Improvement Act that requires the issuance of a Certificate of Conformance for any product that is subject to a CPSC rule.

Drug Enforcement Administration – The DEA is responsible for enforcing the controlled substances laws and regulations.  While most controlled substances are prescription drugs, there are a few OTC products within the DEA’s scope as well.  All of these have additional labeling, packaging, record-keeping and other requirements.

Federal Trade Commission – The FTC protects the public from unfair, deceptive or fraudulent practices in the marketplace. As such it collaborates with the FDA in identifying those drug or dietary supplement products making unsubstantiated claims or that have false or misleading advertisements.

United States Pharmacopeial Convention – The USP is a scientific organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements. Although not a federal agency, its standards are legally enforceable by the FDA.

In addition to the above, there are other laws that have been enacted by Congress in recent years that impact the manufacture and distribution of OTC drugs and dietary supplements, of which regulatory professionals must be cognizant.

Dietary Supplement and Non-prescription Drug Consumer Protection Act – This law was enacted in 2006 and requires manufacturers, packers or distributors whose name appears on an OTC drug or dietary supplement label to submit to the FDA any report received of a serious adverse event associated with their products.  To accomplish this, product labels must include contact details (telephone number or full domestic address) through which the adverse event details can be reported.

Food Allergen Labeling and Consumer Protection Act – This law applies to dietary supplements as well as food and was enacted in 2004 (the labeling provisions of which became effective in 2006).  It identifies eight major food allergens which, if present in the product, must be declared on the label.

Keeping up with existing government regulations, as well as new initiatives that come along, is not an easy task. While larger companies have the luxury of employing departments staffed with experienced and knowledgeable professionals, smaller firms may have only one or two people who are expected to keep the company in compliance (and may have other responsibilities as well.)  Fortunately, there are numerous consulting firms that can provide this expertise and at a cost far lower than that of a product recall should a company’s compliance efforts fall short.  Reaching and maintaining a state of compliance is not only good for your company, it is good for your customers too as they can be assured of purchasing a quality product.

Understanding and Managing Product Recalls

If you a manufacturing firm in any industry, the word “RECALL” is not one that you want to hear.  The media is currently focused General Motors and the recall involving the faulty ignition switch and why it took the company so long to publicize the issue.  These are all good questions for which GM will bear the responsibility to address.  But pharmaceutical companies have their fair share of recalls too, as can be found in the Food and Drug Administration’s (FDA) weekly Enforcement Report.

The Code of Federal Regulations, Title 21, Part 7 (Enforcement Policy) defines the recall procedure and includes when and how a recall should be initiated.  The policy is further described in a guidance document, initially published in 2003.  Yet, some companies are not aware of their obligations and/or downplay problems that arise, believing they do not rise to the level necessitating a recall.

So why are companies reluctant to initiate a recall?  Certainly it is going to cost both money and time; there are the actual recall expenditures, lost income from not having product on the market, investigations into what went wrong and implementing the necessary corrective action.  There is fear of bad publicity and/or potential lawsuits, especially if there is a significant health hazard presented.  In addition, a recall may prompt an FDA inspection, which could result in the agency identifying further deficiencies in your systems and procedures.

These are all very real concerns faced by manufacturing firms but it does not mean that recalls should be avoided.  If one of your products on the market has deteriorated or is not meeting its specification, it is best to act quickly to address the problem.  Identify and isolate the offending product, contact the FDA and make them aware of the situation, investigate the problem and initiate corrective action, prepare your recall communications and contact your customers.  Use the recall as a basis for identifying those systems and procedures that were deficient and take the opportunity to improve them.

If the problem is ignored, the long term consequences could be far greater – lost sales, unhappy customers not to mention possible litigation and the bad publicity that may ensue.  But if the FDA, your customers and the public see that your company is taking safety and regulatory compliance seriously, you will survive a recall and learn from it.

OTC Products in a Consumer Driven World


As any consumer can tell you, the array of over-the-counter (OTC) drug and dietary supplement products on a retail pharmacy shelf can be mind-boggling.  Whether single or multi-ingredient, the choice appears to be unlimited.  If you are like me, in the industry and familiar with the product labels, perhaps it is not so daunting.  But put yourself in the shoes of the average consumer trying to select a product for themselves or their child, with limited knowledge of the ingredients and indications, how do they decide what is most appropriate, particularly if there is no pharmacist on duty?  It is clear that more can be done to help the public in making that choice.

To that end, I recently had the pleasure of attending the annual Regulatory, Scientific and Quality Conference put on by the Consumer Healthcare Products Association (CHPA) in Washington DC.  For those that are not familiar with the organization, CHPA is one of the oldest trade associations in the USA, representing manufacturers and distributors of OTC drugs and dietary supplements.  As advocates for the industry, they provide input to government agencies regarding legislation and are also involved in consumer education promoting safe and effective use of these products.

The program included speakers from many different companies and disciplines as well as a strong showing from the Food and Drug Administration (FDA).  It was heartening to see the communication and desire for collaboration between the public and private sectors, each realizing that the other has a role to play in ensuring consumers have access to quality OTC products.  The topics ranged from new regulatory initiatives (e.g., updates to the OTC monographs), to challenges facing industry (such as supply chain issues), to the importance of quality metrics in manufacturing.  Due to the nature of the conference, not all sessions could be attended but, based on those that were, all were relevant and worthwhile.

The conference confirmed my belief that my job as a quality/regulatory professional is to not only help manufacturers and distributors understand the regulations, but how adherence to them will benefit both themselves and their customers.  In the end, if the labels are clear, concise and correct and that the product inside meets all required quality standards, both the FDA and consumer will be satisfied.

Regulatory Compliance Challenges: OTC Drug and Dietary Supplement Labels

With the Food and Drug Administration’s (FDA’s) two announcements earlier this year regarding its interest in altering or improving the Over-the-Counter (OTC) Drug monograph system which could potentially impact labeling, followed by its proposal one week later to revise the nutrition labeling of foods and dietary supplements, it is clear that keeping your product labeling in compliance to regulation is no easy task.

The initial regulation requiring the Supplement Facts table was published in the Federal Register in 1997 and two years later came the format and content requirements (i.e., Drug Facts) for OTC products.  While these regulations brought a certain amount of uniformity to labels making it easier for consumers to compare products, there continues to be differences among brands as to how the regulations are interpreted or how the information itself is presented on the label.  In addition to what is required by these regulations, there are other laws that impact labeling, e.g. the Food Allergen Labeling and Consumer Protection Act and the Dietary Supplement and Nonprescription Drug Consumer Protection Act.  Thirdly, there are individual State requirements that may come into play, such as California’s Proposition 65 requiring notification that a product contains an ingredient that may cause cancer, birth defects or reproductive harm.  And finally, companies must be cognizant of making false advertising claims that could come to the attention of the Federal Trade Commission.

So how can a manufacturer or distributor keep track of all of these requirements?  There are strategies that can be implemented to help navigate this minefield.

Read and become familiar with the Code of Federal Regulations, or at least those titles and sections that are applicable to your products.  They provide the framework from which any label should be developed.

Be vigilant.  Check the Federal Register routinely for new labeling regulations being published.  Be aware of new legislation that gets enacted by Congress.  Monitor the FDA’s website as well as industry press announcements for new safety information that comes to light regarding a specific product or ingredient.

Know your products.  Know what is in them and be familiar with any regulations that are applicable to the individual ingredients or their quantity within the product that may necessitate an allergen declaration or a quantitative content declaration.

Check competitors’ product labels.  Don’t necessarily rely on them to be correct but, depending on the knowledge and experience of their regulatory personnel, they might include information that you missed and it gives you an opportunity to correct your own labels.

Develop label specifications.  Use these to review your labels while they are being developed or revised. This will ensure uniformity of label content between different package sizes and/or among similar families of products.

Invest in proofreading software.  While this might not be feasible for smaller companies or those with a limited product line, such equipment can detect errors in the text and artwork before they become costly.

Learn from mistakes (both yours and others.)  If you get cited by the FDA for misbranding due to an error or omission, or see that your competitor has, check all of your labels to ensure it is not duplicated elsewhere.

Remember that your label is arguably the best advertisement for your product.  While its artwork may provide the initial attraction for a consumer, the content on that label and how it is presented will not only help with the sale but will also keep the product from subsequently being recalled.