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 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

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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 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


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

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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

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

Mar 27

FDA Warns of Marketing Cosmetics with Drug Claims

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, as something designed for the, “cleansing, beautifying, promoting attractiveness, or altering the appearance [of a person].” By contrast, the Act defines a drug, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” Further, when a product is considered a cosmetic, it generally does not need FDA approval before they are sold to the public. When a product is classified as a drug, then it must generally pass FDA review before it can be marketed to consumers.

FDA has recently noted that many cosmetic companies have crossed the line with claims on their advertising or packaging, causing products that would otherwise be regulated as cosmetics to be considered drugs by the Agency. Recently, the U.S. Food and Drug Administration (FDA) has been issuing warning letters to companies whose claims have gone beyond promoting the cosmetic benefits of their product and into the territory of promising outcomes typically associated with drugs, such as indicating that the product is intended to treat or prevent disease, or change the body’s structure or functions. If a company fails to comply with these rules, the FDA may take additional action beyond issuing a warning letter, which could include removal of a product from the market or other sanctions, which would likely prove costly.

Warning letters that have been issued to cosmetics manufacturers for marketing products with claims that indicate that the product is a drug can be found here. The products range from skin care creams and lotions, hair care products, and even eyelash and eyebrow treatments.

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.

When promoting products in the cosmetics industry, it may be advantageous to sell the potential user on the benefits that they may experience. However, it is extremely difficult for any company to toe the line between cosmetic and drug claims. For this reason, it may be particularly helpful to have a trained professional examine the claims made regarding the product to ensure their compliance with all federal laws and FDA regulations.

We offer assistance to companies with label reviews and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at

Mar 17

FDA Regulation of OTC Sunscreen Products

Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing to wear sunscreen on a daily basis throughout the summer months, it is imperative that the sunscreen on the market is safe and effective. With that in mind, on November 26, 2014, Congress enacted the Sunscreen Innovation Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen with the U.S. Food & Drug Administration (“FDA”).

The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It also does not reduce the amount of adequate and relevant data on which to base FDA determinations regarding sunscreen ingredients. Rather, the regulatory process known as a time and extent application process, or “TEA”, for short, allows manufacturers to request that the FDA inspect certain active ingredients in over-the-counter (“OTC”) products. This process is mostly used when a manufacturer is able to sell an OTC product in foreign countries, but not the United States.

The first step of the TEA is for a manufacturer to prove to the FDA that it has been selling their product, with the requested active ingredient, as an OTC in one or more countries for a certain amount of time and in a manner consistent with the way it would be used in the United States. Next, the FDA will evaluate the available data on the active ingredient to determine whether it is safe for OTC use. The FDA evaluates the data submitted to determine whether an active ingredient is generally recognized as safe and effective (GRASE) for its intended use. If an ingredient is found to be GRASE, then it can be sold OTC in the United States.

Before the Act went into effect, there were 8 TEAs submitted to the FDA for review. On January 7, 2015, six (6) of the eight (8) ingredients were classified as not GRASE for use in sunscreens because more data was needed from the manufacturers to help establish the safety and effectiveness of these ingredients. On February 24, 2015, the final two (2) ingredients were also classified as not GRASE by the FDA for the same reasons as the others, in that more data was needed to demonstrate safety and effectiveness for OTC use.

As the Sunscreen Innovation Act and FDA regulation of sunscreen illustrates, even though some products may be legally sold in other countries, they may still be banned or heavily regulated in the United States. The United States has very stringent controls in place to ensure the highest quality and safety of products sold to consumers. If you are selling a product that is to be ingested or applied to the skin, it can be a difficult process to figure out which rules apply to your product and what procedures must be undertaken in order to safely get your product to market.

We offer assistance with premarket review, label reviews, and ensuring that your product complies with FDA regulations. If you would like assistance with your products, please contact us at


Feb 12

FDA Stops Company from Marketing Unapproved New Drugs

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs and devices.

According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs. As explained by FDA, the company undertook steps to correct the violations, but the Agency deemed the response ineffective. In February 2013, the FDA issued a warning letter to the company for violations of the CGMP and the Federal Food, Drug, and Cosmetic Act (FFDCA) by manufacturing and marketing both over-the-counter (OTC) and prescription drug products without an approved application (unapproved new drugs). According to the FDA Warning Letter, the Agency deemed the products to be drugs due to certain disease claims made in the Company’s marketing materials and since no approved applications were held by the Company, the products were deemed unapproved new drugs. For example, some of the claims at issue included: “Methods and composition for the treatment of vaginal diseases employing peroxide-producing enzymes and peroxidases,” “Helps Prevent The Causes Of Vaginosis, Yeast Infection and Bad Odor,” and “Probiotics: Potential to Prevent HIV and Sexually Transmitted Infections in Women.” Accordingly, the Company’s labeling was one of the major issues that led to FDA’s finding of unapproved new drugs, prompting FDA enforcement action.

On June 25, 2014, the FDA filed for a permanent injunction , as the Agency argued that the Company’s operations remained non-compliant with FDA regulations. That injunction was granted on January 30, 2015. One of the main issues here was Laclede’s failure to properly label their products. The consent decree for permanent injunction specifies that Laclede may not market any products with the words “prebiotic” or “actibiotic” on its labels or packages without first obtaining the FDA’s approval. In addition, Laclede may not market any products referencing “lubrication” without appropriate FDA approval.

In sum, properly labeling products is one of the most critical steps in the product development process. Compliance with the regulations is a must to ensure that your products stay on the shelf and that your company is not the subject of FDA enforcement action. Our firm offers comprehensive label reviews and packaging requirement assistance to help our clients ensure that their products are fully compliant with all applicable rules and regulations. If you would like assistance with your products, please contact us at

Feb 04

FDA Guides on General Wellness and Low Risk Devices

On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is …intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man … or intended to affect the structure or any function of the body of man….”

In the recently published FDA guidance, the FDA is instructing its staff not to consider “general wellness products” as “devices” for purposes of the FDCA, meaning that these low risk devices will not have the considerable oversight that other “devices” receive from the FDA. The proposed guidance document defines a “general wellness product” as meeting a two-factor test. First, that the products are intended for only general wellness use, as defined in this guidance. Second, that the products present a very low risk to users’ safety. However, the decision by the FDA not to regulate these products does not mean that those classes of products are safe, effective, and not misbranded for its intended use.

General Wellness Products

For a product to be classified as a general wellness product, it must meet one of two criteria:

1. It must have, “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity;” or

2. It must have an, “intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of                  certain chronic diseases or conditions…”

General wellness products are allowed to make claims about improving a general state of health, but they must not make any references to diseases or conditions. General wellness products are only allowed to make references to diseases or conditions when it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. This means that generally accepted science has proven that healthy lifestyle choices may play an important role in health outcomes.

Low Risk Devices

If a product presents an inherent risk to the safety of the user, then it is not exempted by this guidance document. If a product does any of the following four things, then it is not a low risk product for purposes of this guidance document and is not considered a general wellness product if:

1. the product is invasive;

2. the low risk device involves an intervention or technology that may pose a risk to a user’s safety if device controls are not                    applied, such as risks from lasers, radiation exposure, or implants;

3. it raises novel questions of usability, or

4. if the low risk device raises questions of biocompatibility.

This guidance document is an interesting stance from the FDA insomuch as the FDA is taking a self-limiting position by essentially saying that the Agency should not be regulating these devices. Rarely does the FDA take such a self-limiting stance on issues of product regulation. However, just because the FDA is not regulating these General Wellness products, it does not mean that they are completely unregulated. The Consumer Product Safety Commission (CPSC) may also have the authority to decide whether a general wellness product is a consumer product under CPSC’s authority vested in it by the Consumer Product Safety Act. Accordingly, how this guidance document and federal law will be applied in practice remains to be seen.

A guidance document serves as the Agency’s official stance on a subject. Further, it does not create any legally enforceable duties upon the Agency. It solely guides the decision makers within an agency to uniformly apply the specified laws and regulations. This proposed guidance document is open to public comment before it becomes final. Currently, electronic comments can be sent to the FDA at this website. The public comment period is open for 90 days, and then the Agency will review all of the comments that are received and will finalize the guidance document.

Navigating the web of regulations and regulatory bodies can be a daunting task. When selling or distributing a product, a company must be absolutely certain that they are meeting all regulatory requirements or risk enforcement action. If you think your product may be affected by the new guidance document and want to be sure your claims and labeling are in compliance or see how you may be regulated by FDA, our office offers reviews of product labels and health claims. If you have any questions about the new guidance document or whether your product is considered a “device” please contact us at

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