Apr 20

FDA Imports: Tradeoff — Less Vigilance for More Diligence

The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports.  Troubled by its inability to get Congressional funding to pay all of its bills, the FDA came up with an idea: have the importer and the food manufacturer pay for the inspections and re-inspections.  With congressional approval, the Food Safety Modernization Act (2011) provides the FDA with the authority to charge such fees based on past costs (currently 2013) of inspections and re-inspections, and leverage this authority to get improved behavior from the importers, and food manufacturers, and related supply chain vendors.  The FDA is also offering a program where it will relax its typical schedule of inspection and re-inspection for those companies that prove great diligence in complying with FDA requirements pertaining to FDA imports, and join the FDA’s “Voluntary Qualified Importer Program” (VQIP).

What FDA Offers for FDA Imports (documented in VQIP):

Some of the benefits that the FDA offers to those who join VQIP and have records of diligence and compliance:

  • Near immediate release of FDA imports that are named in an approved VQIP
  • Prioritized analysis of samples taken for cause or health alert
  • Allow the importer to choose to be listed as a member of VQIP that is in good standing
  • A VQIP in good standing will face review only after three years

These and other benefits make the importer’s efforts less encumbered.  FDA Imports can be held “for as long as necessary”, but are typically held three days to a week due to the amount of imports that come through a port.  This delay does not include the need to take sampling when a public health alert occurs.  Also, an importer’s reputation can be enhanced by being listed on the FDA’s VQIP “good standing” site.

FDA’s Requirements (documented in VQIP):

Some of the requirements the FDA has for applicants and holders of VQIP approved applications are:

  • Have a VQIP “Quality Assurance Program” (QAP) – as a part of VQIP application submission
  • Have every importer, manufacturing and supplier entity involved in the food or foods in the VQIP application be in good standing with the FDA.  Those having no standing as yet with the FDA require an inspection with the cost of the entity’s inspection paid for by the entity or those entities under the application
  • A Dun & Bradstreet issued number (DUNS#) for each entity involved with the foods under the VQIP application.
  • Provide a food label for each food to be covered by the VQIP application with the VQIP application

The first two requirements listed, the QAP and the importer’s entire supply chain (IESC) in good standing with the FDA, are the ones that will be costly for the IESC.  If any part of the IESC gets an inspection finding, the existing VIQP application could be in jeopardy, and require re-inspection at IESC expense.  It is not an easy decision to make.

FDA’s Gamble: Hold Pat; But Needs Players

The FDA may be well-intentioned with implementations of FSMA, but its gamble on VQIP only pays off if importers see long term value in joining and complying with FSMA and VQIP.  Otherwise, it is business as usual, seeking budget from Congress, and looking for ways to do its job in the face of increasing numbers of importers and a budget that holds the FDA back.  Importers and their supply chain will continue to face delays in release, sporadic re-inspections that delay clearance of findings, and delays in getting information and help getting through the import / broker process.

We can help you in assessing what FSMA and VQIP mean to you as an importer or member of a supply chain, as well as other FDA regulations.  Together we would review the legal and regulatory basis for your VQIP application submission, and determine the appropriate measures needed to establish compliance with federal laws and FDA regulations on your behalf. For more information about hiring a FDA regulatory lawyer to help you make a knowledgeable decision on this FDA innovation, FDA imports, and benefit from diligent FDA compliance, please contact us at contact@giannamore-law.com.

FDAKG Logo Final 150x150 FDA Imports: Tradeoff    Less Vigilance for More Diligence

Jan 21

District Court sides with Industry on Dietary Supplement Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses competent and reliable scientific evidence to support the claim.”  The current decision originates from a motion for an order to show cause filed by the Department of Justice (DOJ) on behalf of the Federal Trade Commission (FTC) and further originates from a 2011 FTC investigation concerning whether Bayer possessed competent and reliable scientific substantiation for its claims regarding PCH’s effectiveness as a digestive health product.

Based on evidence collected from its investigation, the DOJ’s motion alleged Bayer should be held in civil contempt for violating the 2007 consent decree concerning the requirement that Bayer substantiates its dietary supplement claims with scientific evidence. Specifically, the motion alleged that Bayer wrongfully made claims that PCH supports digestive health, and the product would help alleviate constipation, diarrhea, and gas and bloating without specific randomized, double-blind, placebo-controlled trials to prove that PCH offers these health benefits. In short, the Government’s position, like we have seen time and time again from the FTC, is that the Company must have conducted human studies in order to make the arguably dietary supplement-type claims.

In defense of the motion, Bayer produced as evidence a substantial amount of public domain and proprietary scientific evidence in support of its claims regarding PCH’s effectiveness in fostering digestive health. Further, Bayer argued the DOJ’s reliance on Bayer’s lack of substantiation of its product claims exceeded legislative intent for how dietary supplements should be regulated under the Dietary Supplement Health and Education Act (DSHEA). Thus, Bayer countnered the type of evidence required to substantiate claims under the DSHEA was not Laine-Level randomized clinical trials. In other words, Bayer argued that dietary supplements do not need the requisite level of substantiation that would be necessary for the approval of a drug under federal law. Accordingly, Bayer argued it only needed to conduct a periodic review of the literature since Bayer’s structure function claims were not implied disease claims and that the appropriate scientific substantiation standard for structure-function claims does not require Laine-Level randomized clinical trials.

The main takeaway from this is that for dietary supplement manufacturers making structure/function claims, courts may be willing to interpret this a less rigorous evidentiary burden when it comes to claims substantiation, as opposed to more highly regulated products. Additionally, and somewhat more controversially, this decision has been interpreted by some to signal that digestive health structure/function claims are more expansive than originally thought, potentially including constipation, diarrhea, gas and bloating.

Navigating the web of regulations governing claims regarding dietary supplements can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of dietary supplements, please contact us at contact@giannamore-law.com.

Jan 11

FDA Clears Device via De Novo Process

On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy.  Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market.

After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer. More information about the device may be found here.

The FDA cleared the DigniCap through the de novo process. The de novo process, a relatively new pathway, provides an alternate means of clearing novel devices of low to moderate risk. Initially, Dignitana submitted the device for Premarket Approval (“PMA”) to the FDA at the beginning of 2015. After a brief review, the FDA converted the PMA to the de novo regulatory pathway since the FDA did not consider the DigniCap System a high-risk device warranting a PMA.

Through the De Novo process, device sponsors are able to utilize a hybrid-type pathway for clearance by bringing low-risk devices to market in situations where they would not otherwise be able to utilize the more confined 510(k) pathway. In particular, where the 510(k) pathway is most-frequently used to clear new devices, it is only available to those new devices that have a clear predicate device or are substantially equivalent to another legally marketed device. Devices that do not otherwise have a predicate device available but are still lower-risk that would be appropriate to merit a PMA, now have a pathway via the de novo process. More information about the De Novo process can be found here and here.

Navigating the FDA’s web of regulations governing medical devices can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of a medical device, please contact us at contact@giannamore-law.com.

Jan 11

FDA “Natural” Food Labeling

On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input after receiving two Citizen Petitions requesting the agency take action on establishing a formal definition of the term “natural” for use in food labeling and one requesting asking that the agency prohibits the use of the term “natural” on food labels.

The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in which some federal courts requested administrative determinations from the FDA as to the propriety of labeling of food products containing genetically engineered ingredients or high fructose corn syrup as “natural.”

While FDA regulations presently do not offer a formal definition of the term “natural,” the Agency has maintained a longstanding policy concerning the use of “natural” in human food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.”  Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

As part of the public comment process the FDA requests information on whether it is appropriate to define the term “natural;” suggestions as to how the agency should define “natural,” and the term’s appropriate use of the term on food labels. The FDA is accepting public comments through February 10, 2016.

For more information about hiring a FDA regulatory lawyer to help you develop FDA-compliant labeling or how you can achieve FDA compliance, please contact us at contact@giannamore-law.com.KG Logo Final 150x150 FDA Natural Food Labeling

Sep 10

What’s in a Name? Everything, for “Standard” FDA Food Labeling


Particular words mean everything to the U.S. Food and Drug Administration (FDA).  It takes great pains and uses specific words to proclaim its position, and clarify what it names something, especially when it comes to setting a standard.  Most of us who have dealt with or follow FDA activities are well aware of FDA rules, such as those set forth in 21 CFR. What many do not know or realize is that the FDA has set standards for what is in, and what is not in, a commonly named food, such as mayonnaise, or tomato paste. These standards are a part of 21 CFR regulations.  Each of these foods, as well as many others, are set forth in 21 CFR Chapter 1, Sub-Chapter B, “Food For Human Consumption”. In these various sections the FDA states unequivocally what is in the food called “mayo” or “tomato paste”, and, often by omission, what is not in these foods.

May-o?  No, You are Not, by FDA Standard

As stated above, precision is essential to provide makers and sellers of food items and flavoring with clarity as to what their products are.  When a store or website advertises a human consumable food using “common names” like “Mayo”, “Mayonnaise”, or “Tomato Paste”, but has left out specific ingredients, or has added in specific ingredients that are not included in the regulations, the food item may have gone beyond the FDA definition and become a different food that may not use these identifying names.

In a recent warning letter, the FDA takes an internet food seller to task for such a violation. Found here, the FDA specifically targeted the company for marketing a food item as “mayo”, despite the fact that the product does not contain eggs. Makes it healthier, right? In addition to removing the egg component, the seller also has added a specific starch product to help with consistency of the food item. But, this is a component that is not typically in mayo.  For these and other reasons, the FDA tells the seller that it is misleading the public in its advertising, finding its labeling to be non-compliant with FDA food labeling regulations – in short, saying that mayo has eggs, and this product does not.

Another Path down into FDA Enforcement

In a too-familiar occurrence, when a seller violates one aspect of FDA food labeling regulations, the added event of labeling violations follows close behind. The standard phrasing of such violations called out in the FDA letter states: “This letter is not an all-inclusive statement of violations associated with your products or their labeling ….  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.”  Now the seller must update the site, within 15 days, removing all references to “mayonnaise”.

FDA Compliance – Seller Must Know, and Follow, the Rules

It is essential that a person selling food items understand and comply with FDA food labeling regulations. FDA food labeling regulations are non-negotiable marketing requirements a seller must meet to avoid FDA warnings.

For more information about hiring a FDA regulatory lawyer to help you make a knowledgeable decision on these and other applicable FDA regulations, please contact us at contact@giannamore-law.com.KG Logo Final 150x150 What’s in a Name? Everything, for Standard FDA Food Labeling

Jun 30

FDA Bans Trans Fats

FDA Issues Final Determination Concerning Partially Hydrogenated Oils

The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs).  FDA recently issued its final decision on how it would categorize PHOs.  Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats.  This change in categorization now puts PHOs under the regulations that govern food additives.  Current registrations of foods containing PHOs and their labeling must eliminate PHOs by June 2018.  The FDA will allow registrants to obtain new registration of use of PHOs in foods under much stricter guidelines.

FDA’s Long Pursuit of Trans Fats – A Troubled Relationship

The FDA began its relationship with trans fats and PHOs in 2006 when the FDA required that the amount of trans fats in a food be put onto the ingredients listing of the FDA-required Nutrition Facts label.  Trans fat is listed as a part of the Saturated Fat listing.  Since trans fat is typically a percentage of Saturated Fat, trans fat could list at zero grams but still be present in the food, up to 0.5 grams of trans fat, and allow the continued use of PHOs.  This is no longer the case.

The reason PHOs became important in the food industry is that PHOs have a longer shelf life and are cheaper than other fats and oils to use in recipes.  Removal of PHOs from a food means potential changes to the Nutrition Facts label for that food.  Additionally, for an imported food currently containing PHOs, the importer will be responsible for getting its food source manufacturer to reformulate and eliminate the PHOs.

FDA’s Scope on PHOs and Trans Fat is Black and White

Using the Federal Register to issue a Declaratory Order, rather than proceeding through formal rulemaking (with the necessary notice and comment periods) the FDA has set its boundaries on what is non GRAS, on what must be eliminated, and what occurs outside these boundaries.  One boundary is that this order is for PHOs only and excludes FHOs, fully hydrogenated oils.  The Order also excludes naturally occurring trans fats, those that are not a part of PHO manufacture.  The Order clearly defines PHOs as “as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.”    The Order also provides that “Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s).

FDA’s follow-up … What’s Next?

The FDA will be busy from now through June 2018 with updates to a multitude of Nutrition Fact labels, as well as new and revised food additive submissions seeking FDA’s approval to use PHOs in some “safe” manner.  For food imports containing PHOs, this means an updated recipe with an updated Nutrition Fact label, otherwise the importer may lose the ability to import.  FDA will then be able to seize imported foods and additives containing unapproved PHOS, categorizing them as adulterated, illegal imports.  With three years available to make necessary changes, violators will get little sympathy from the FDA, and may be subject to warning letters and seizure for continued non-compliance.

We can help you comply this order and other FDA regulations by reviewing the legal and regulatory basis for your updated Nutrition Facts label and determine the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary. For more information about hiring a FDA regulatory lawyer to help you respond to this FDA Declaratory Order or how you can achieve FDA compliance, please contact us at contact@giannamore-law.com.

FDAKG Logo Final 150x150 FDA Bans Trans Fats

May 04

FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection with tobacco retailer inspection violations. The FDA has the authority to regulate tobacco products under the FD&C Act as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act, which was enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate tobacco products.

The FDA has been aggressively enforcing the Tobacco Control Act, largely against convenience stores and gas stations selling tobacco products in violation of the Tobacco Control Act by issuing tobacco warning letters quite frequently over the past several months. FDA regulations applicable to tobacco retailers prohibit the sale of cigarettes and smokeless tobacco to any person younger than 18 years of age, and impose other restrictions on labeling, marketing, and advertising of cigarettes and smokeless tobacco.

When a FDA compliance inspection reveals a violation, the tobacco retailer first receives a tobacco warning letter. A tobacco warning letter, like other FDA warning letters, contains a list of all of the violations observed during the inspection and directs the tobacco retailer to respond in writing with a plan to correct the observed violation. After receiving a tobacco warning letter, a business must respond to the FDA within 15 working days. The response to the FDA should include an explanation of the steps that the business will take to correct the violations and to prevent future violations, as well as the current contact information for the business.

After the receipt of a tobacco warning letter, if a tobacco retailer fails to correct the violation, it may result in the FDA taking regulatory action without any further notice to the tobacco retailer. Under the FD&C Act, as amended by the Tobacco Control Act, the FDA is authorized to issue a civil money penalty, no-tobacco-sale order, seizure, criminal penalties, and/or an injunction, which would prohibit the business from further tobacco sales.

Tobacco Control Act and Tobacco Retailers

The FDA can issue tobacco warning letters due to a number of different violations of the requirements set forth in the Tobacco Control Act. In particular, the regulations:

  • Prohibit the sale or distribution of brand-identified promotional nontobacco items such as hats and tee shirts;
  • Prohibit the sponsorship of sporting and other events, or teams;
  • Prohibit free samples of cigarettes and restrict distribution of free samples of smokeless tobacco to “qualified adult-only facilities;”
  • Require retailers to verify a purchaser’s age by photographic identification.
  • Prohibit opening cigarette or smokeless tobacco packages to sell products in smaller amounts;
  • Prohibit free samples of cigarettes.

Often, convenience stores and other establishments receive tobacco warning letters in connection with this final requirement – the failure to verify a purchaser’s age, which may also result in Warning letters issued by the FDA for violations of the Tobacco Control Act can be viewed here.

Tobacco Warning Letters: What’s Next?

If your business receives a tobacco warning letter or notice of a tobacco retailer inspection violations, it is extremely important that you take swift action to correct the violations. As stated in all tobacco retailer warning letters, a business only has 15 working days to respond to the FDA. Without a response, the FDA can pursue further legal action against your business with no further notice. 15 days is an extremely short period of time and once a warning letter is received, so swift action must be taken.

We can help you respond to tobacco warning letters and other FDA warning letters by reviewing the legal and regulatory basis for your warning letter, determining the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary, and drafting a response to your warning letter on your behalf. For more information about hiring a FDA regulatory lawyer to help you respond to FDA warning letters or how you can achieve FDA compliance, please contact us at contact@giannamore-law.com.KG Logo Final 150x150 FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

Apr 30

Potential Changes to FDA Regulation of Homeopathic Drugs

On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of regulating homeopathic drugs in a manner consistent with over-the-counter (OTC) drugs. A primer for the public hearing can be found in the federal register, here.

Homeopathy began in the 18th century, based off of teachings from a German scientist, Samuel Hahnemann. The main concept in homeopathy is that, “like cures like” (similia similibus curentur) meaning that disease causing substances can also be used to cure those same diseases, if the substances are greatly diluted.

The FDA is considering whether homeopathic drugs should be treated like OTC drugs and undergo clinical trials to be proven safe and effective, as well as obtain approval for labeling. The new calls for regulation are in response to the current boom of the homeopathic industry in recent years. The last time that homeopathic drugs were examined by the FDA was in 1988. In 1988, homeopathic products were only a multimillion-dollar industry in the United States. According to the Center for Disease Control and Prevention, sales of homeopathic products reached nearly $3 billion in 2007. Due to the increased sales volume of homeopathic products and concern in recent years, the FDA believes that it now has more information to work with in order to make a decision.

Currently, homeopathic drugs are subject to various FDA administered laws and regulations. In particular, homeopathic drug manufacturers must also comply with certain FDA regulatory requirements, explained here in the compliance policy guide and explaining the conditions under which homeopathic drugs may be marketed. Further, manufacturers must also comply with the Food, Drug, and Cosmetic Act. Accordingly, industry advocates argue that the current regulatory scheme is more than adequate to ensure that consumers who choose homeopathic products receive safe and effective products.

Currently, the FDA is gathering information about homeopathic drugs in order to determine if they should be regulated like other over the counter medicines, like aspirin or decongestants and require approval for marketing. Because the state of laws and regulations applicable to homeopathic drugs may be changing very soon, any person or company in this industry should be on alert for changing requirements for their products. It is important to consult with an expert before any new policy comes into effect to ensure full compliance with new laws and regulations.

We offer comprehensive FDA compliance assistance, including label reviews and reviews of health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at contact@giannamore-law.com.


Apr 23

US Marshals Seize Topical Products Deemed Drugs by FDA

On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, Inc. of New Jersey and marketed the topical products, deemed drugs by the FDA to consumers.

The FDA conducted an inspection in late 2014 that revealed that Stratus was marketing these topical products without first acquiring the required FDA-approved drug applications, which is typically required when marketing drug products under the Federal Food, Drug and Cosmetic Act (“FFDCA”). The FDA found these products to be drugs under the FFDCA, as opposed to cosmetics, like many other topically-applied products, as they were being marketed to treat various diseases and/or conditions, including:

  • a solution used to treat excessive sweating;
  • an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea and seborrhea;
  • a topical ointment used to treat wounds;
  • a topical cream and gel to treat psoriasis, eczema and other skin conditions; and
  • analgesic ear drops used to treat ear pain.

After the investigation concluded, the U.S. Attorney’s Office filed a complaint in federal court in the Southern District of Florida, alleging that the products sold by Stratus are unapproved new drugs and misbranded drugs under the FFDCA.

The FDA had the authority to seize Stratus’ products under the FFDCA, as explained in detail in the Marketed Unapproved Drugs Compliance Policy Guide. The compliance policy guide states that persons or companies that are marketing unapproved drugs are subject to FDA enforcement at any time. The FDA is not required to, and generally does not give special prior notice to a person or company that a drug product may be subject to enforcement action, including seizures.

The Policy guide also explains the priorities of the FDA for enforcement actions against violators. The enforcement priorities include drugs with potential safety risks, drugs that lack evidence of effectiveness, drugs that are reformulated to evade an FDA enforcement action, and unapproved new drugs that also violate the FFDCA in other ways (such as a new drug violating current good manufacturing practice).

Prior to marketing any product that may be deemed a drug or pharmaceutical product, it is very important that all steps be completed correctly to ensure compliance with, not only the Federal Food, Drug, and Cosmetic Act, but all other applicable laws. To ensure that your drug or cosmetic product is not in violation of federal law, it is important to consult with a seasoned professional.

We offer professional assistance to companies and individuals seeking to comply with all applicable rules and regulations. Our firm offers comprehensive review of structure function claims, label reviews, and health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at contact@giannamore-law.com.

KG Logo Final 150x150 US Marshals Seize Topical Products Deemed Drugs by FDA



Apr 07

Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of the industry’s premier sources for specialized, in-depth coverage and analysis of regulatory and market developments across the personal care and cosmetics industries. The full text of the article interview may be accessed here.

The article focuses on cosmetics companies’ efforts to simultaneously promote their products effectively while abiding by all applicable laws and regulations. On this blog, we have previously discussed the challenges and pitfalls associated with marketing cosmetics with drug claims. In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

Many small companies choose to invest in regulatory counsel before putting their products out on the marketplace. Giannamore described her role as a regulatory counsel as, “scal[ing] [the cosmetics companies] back, pointing out what things are definitely going to get you in trouble while keeping in mind that the product has to do something.” The marketing process is usually a risk aversion exercise, seeing how much risk the company wants to take on. She further described the role of regulatory counsel as, “finding creative ways” to convey the benefits of a product without violating the Federal Food, Drug, and Cosmetic Act.

Giannamore went on to tout the benefits of hiring regulatory counsel at an early stage of the product development process. “A lot of people come to me and they already have an FDA warning letter, or they’re importing and they’ve been stopped [due to excessive claims or other issues],” said Giannamore. Many times the companies do not hire regulatory counsel, “due to lack of resources in the beginning or it just not being something that’s high on the totem pole because they’re thinking ‘We’re a small company, [the FDA] is not going to target us.’”

Hiring regulatory counsel can prove to be a sound business decision, despite the cost, particularly because of the additional expense that would be incurred if the company receives a FDA warning letter. Recently, John Bailey, of the EAS Consulting Group and formerly a director of the FDA’s cosmetics program and the chief scientist at the Personal Care Products Council, addressed the substantial costs associated with an FDA warning letter or instituting corrective measures. The FDA may require companies to re-label their products and can have production and shipments shut down in the meantime.

The actual costs of an FDA warning letter may be even greater than just the cost to re-label products and lost sales. In addition, a FDA warning letter is a public relations nightmare, according to Giannamore. “If anybody’s ever Googling you, that’s now the first thing that comes up… They’re going to say ‘Oh my God, they have a warning letter; don’t buy their product.”

We offer assistance to companies with label reviews, reviews of their marketing content, and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@giannamore-law.com.

KG Logo Final 150x150 Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

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